Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10596276 DP* Stable, concentrated radionuclide complex solutions Claim Types: Product-by-proces; Process Pat. Sub. Date(s): 001: Apr 13, 2020 | Jul 25, 2038 | |
| Pat. No. 10596278 DP* Stable, concentrated radionuclide complex solutions Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 13, 2020 | Jul 25, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 26, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 26, 2025 | ODE-166: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) including foregut, midgut, and hindgut neuroendocrine tumors in adults |
AAA USA INC
NETSPOT (POWDER) (INTRAVENOUS) GALLIUM DOTATATE GA-68
NDA Applicant: AAA USA INC NDA No.: 208547 Prod. No.: 001 RX (2.1-5.5mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9375498 DP* Process for the preparation of complexes of .sup.68Ga Claim Types: Kit; Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Jul 9, 2018 | Aug 10, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 1, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 1, 2023 | ODE-120: For use after radiolabeling with Ga 68, with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. |
AADI
FYARRO (POWDER) (INTRAVENOUS) SIROLIMUS
Drug Classes: Immunological Agents:Immunosuppressants == kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: AADI NDA No.: 213312 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8911786 DP* Nanoparticle comprising rapamycin and albumin as anticancer agent Claim Types: Method of use; Formulation; Kit Pat. Sub. Date(s): 001: Dec 17, 2021 | Feb 14, 2029 | U-3259: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) |
| Pat. No. 10206887 DP* Prion free nanoparticle compositions and methods of making thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2021 | Apr 15, 2030 | |
| Pat. No. 10705070 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Claim Types: Process Pat. Sub. Date(s): 001: Dec 17, 2021 | Mar 5, 2036 | |
| Pat. No. 10973806 Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2021 | Jun 29, 2036 | U-3258: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose between about 56 mg/m2 and about 100 mg/m2 administered on days 1 and 8 of a 21-day cycle |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 22, 2024 |
ABBVIE
ANDROGEL (GEL; GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB1]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ABBVIE NDA No.: 021015 Prod. No.: 001 RX (25MG/2.5GM PACKET); 002 RX (50MG/5GM PACKET) NDA No.: 021015 Prod. No.: 003 DISC (12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration Pat. Sub. Date(s): All strengths: None | Mar 1, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 14, 2015 | Mar 2, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Mar 2, 2021 *PED | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
ABBVIE
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ABBVIE NDA No.: 022309 Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)); 003 RX (1.62% (40.5MG/2.5GM PACKET))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration Pat. Sub. Date(s): 001: None; 002: May 23, 2014; 003: May 23, 2014 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8466136 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | |
| Pat. No. 8466137 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8466138 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8486925 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2013 | Oct 12, 2026 | |
| Pat. No. 8729057 DP* Testosterone gel and method of use Claim Types: Composition Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014 | Oct 12, 2026 | |
| Pat. No. 8741881 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2014 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8754070 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 16, 2014 | Oct 12, 2026 | |
| Pat. No. 8759329 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2014 | Oct 12, 2026 | |
| Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 14, 2015 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2015 | Mar 2, 2021 *PED | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
ABBVIE
TRICOR (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE NDA No.: 021656 Prod. No.: 001 RX (48MG); 002 RX (145MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7276249 DP* Nanoparticulate fibrate formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Feb 21, 2023 | |
| Pat. No. 7320802 Methods of treatment using nanoparticulate fenofibrate compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Feb 21, 2023 | U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V) |
ABBVIE
TRILIPIX (CAPSULE, DELAYED RELEASE) (ORAL) CHOLINE FENOFIBRATE [GENERIC AB]
NDA Applicant: ABBVIE NDA No.: 022224 Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Jan 7, 2025 |
ABBVIE
ZEMPLAR (SOLUTION) (INTRAVENOUS) PARICALCITOL [GENERIC AP]
Drug Classes: Metabolic Bone Disease Agents == vitamin D3 analog
NDA Applicant: ABBVIE NDA No.: 020819 Prod. No.: 001 RX (0.005MG/ML (0.005MG/ML)); 002 RX (0.002MG/ML (0.002MG/ML)); 003 RX (0.01MG/2ML (0.005MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Oct 18, 2023 |
ABBVIE
ZEMPLAR (CAPSULE) (ORAL) PARICALCITOL [GENERIC AB]
Drug Classes: Metabolic Bone Disease Agents == vitamin D3 analog
NDA Applicant: ABBVIE NDA No.: 021606 Prod. No.: 001 RX (1MCG); 002 RX (2MCG) NDA No.: 021606 Prod. No.: 003 DISC (4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2023 | ODE-125: Indicated in pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and ckd stage 5 in patients on hemodialysis or peritoneal dialysis |
ABBVIE ENDOCRINE INC
LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC NDA No.: 020517 Prod. No.: 003 RX (45MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8815801 DP* Controlled release composition and method of producing the same Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 13, 2015 | Jun 28, 2022 | |
| Pat. No. 8921326 DP* Sustained-release composition and method for producing the same Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 13, 2015 | Feb 5, 2031 | U-1666: Palliative treatment of prostate cancer |
ABBVIE INC
DUOPA (SUSPENSION) (ENTERAL) CARBIDOPA; LEVODOPA
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors == Antiparkinson Agents:Antiparkinson Agents, Other == aromatic amino acid decarboxylation inhibitor
NDA Applicant: ABBVIE INC NDA No.: 203952 Prod. No.: 001 RX (4.63MG/ML;20MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2022 | ODE-84: Treatment of motor fluctuations in patients with advanced Parkinson's disease |
ABBVIE INC
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC NDA No.: 209394 Prod. No.: 001 RX (100MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 29, 2017 | Jul 19, 2032 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 8937150 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 29, 2017 | Nov 18, 2032 *PED | |
| Pat. No. 9321807 DS* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 29, 2017 | Dec 5, 2035 *PED | |
| Pat. No. 9586978 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 29, 2017 | May 6, 2031 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 10028937 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 24, 2018 | Dec 10, 2030 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 10039754 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Dec 10, 2030 *PED | U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Pat. No. 10286029 Method for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2019 | Sep 14, 2034 *PED | U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Mar 26, 2023 PED | D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study |
| Exclusivity Code: M - Miscellaneous | Aug 6, 2021 | M-230: Revisions to the glecaprevir/pibrentasvir combination product prescribing information to include safety and efficacy data from the HCV/HIV-1 coinfection study M14-730 and from the liver and renal transplant study M13-596 |
| Exclusivity Code: M - Miscellaneous | Oct 10, 2023 PED | M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection |
| Exclusivity Code: NCE - New chemical entity | Feb 3, 2023 PED | |
| Exclusivity Code: NPP - New patient population | Oct 30, 2022 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 30, 2026 PED | ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 30, 2026 PED | ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 10, 2028 PED | ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both |
ABBVIE INC
MAVYRET (PELLETS) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC NDA No.: 215110 Prod. No.: 001 RX (50MG;20MG/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Jul 19, 2032 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 8937150 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 8, 2021 | Nov 18, 2032 *PED | |
| Pat. No. 9321807 DS* DP* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jul 8, 2021 | Dec 5, 2035 *PED | |
| Pat. No. 9586978 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | May 6, 2031 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 10028937 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Dec 10, 2030 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 10039754 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Dec 10, 2030 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Pat. No. 10286029 Method for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021 | Sep 14, 2034 *PED | U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Mar 26, 2023 PED | D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study |
| Exclusivity Code: M - Miscellaneous | Oct 10, 2023 PED | M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection |
| Exclusivity Code: NCE - New chemical entity | Feb 3, 2023 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 10, 2028 PED | ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both |
ABBVIE INC
ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary)
NDA Applicant: ABBVIE INC NDA No.: 213388 Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6872728 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 29, 2020 | Jan 25, 2021 | |
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 29, 2020 | Sep 10, 2024 | |
| Pat. No. 7179815 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 29, 2020 | Mar 7, 2021 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 29, 2020 | Jul 6, 2024 | |
| Pat. No. 7462625 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 29, 2020 | Jan 25, 2021 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 10881659 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 3, 2021 | Mar 14, 2034 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Pat. No. 11045470 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 27, 2021 | Mar 14, 2034 | U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 | |
| Exclusivity Code: NP - New product | May 29, 2023 |
ABBVIE INC
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary)
NDA Applicant: ABBVIE INC NDA No.: 210450 Prod. No.: 001 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6872728 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 20, 2018 | Jan 25, 2021 | |
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 20, 2018 | Sep 10, 2024 | |
| Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7179815 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Mar 7, 2021 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7462625 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 20, 2018 | Jan 25, 2021 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 10537572 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 19, 2020 | Sep 1, 2036 | U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin |
| Pat. No. 10682351 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 15, 2020 | Sep 1, 2036 | U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ABBVIE INC
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary)
NDA Applicant: ABBVIE INC NDA No.: 210450 Prod. No.: 002 RX (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6872728 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Aug 20, 2018 | Jan 25, 2021 | |
| Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Aug 20, 2018 | Sep 10, 2024 | |
| Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7179815 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Mar 7, 2021 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Jul 6, 2024 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7462625 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Aug 20, 2018 | Jan 25, 2021 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ABBVIE INC
QULIPTA (TABLET) (ORAL) ATOGEPANT
NDA Applicant: ABBVIE INC NDA No.: 215206 Prod. No.: 001 RX (10MG); 002 RX (30MG); 003 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Jul 19, 2032 | U-3142: Preventive treatment of episodic migraine in adults |
| Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Nov 10, 2031 | U-3142: Preventive treatment of episodic migraine in adults |
| Pat. No. 9850246 DS* Process for making CGRP receptor antagonists Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Mar 13, 2033 | |
| Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 26, 2021 | Jan 30, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 28, 2026 |
ABBVIE INC
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE INC NDA No.: 211675 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 001: Sep 13, 2019 | Dec 1, 2030 | |
| Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 13, 2019 | Jan 15, 2031 | U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: Sep 13, 2019 | Oct 17, 2036 | |
| Pat. No. 9963459 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpla]pyrrolo[2,3-e]-pyrazin-8-YL)-N-(2- ,2,2-Trifluoroethyl)pyrrol and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2019 | Oct 17, 2036 | |
| Pat. No. 10519164 DP* Processes for the preparation of (3S,4R)-3,ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 29, 2020 | Oct 17, 2036 | |
| Pat. No. 10597400 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2020 | Oct 17, 2036 | U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers |
| Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: May 18, 2021 | Oct 17, 2036 | |
| Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 18, 2021 | Oct 17, 2036 | |
| Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Dec 17, 2021 | Oct 17, 2036 | |
| Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2021 | Oct 17, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 16, 2024 |
ABBVIE INC
TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == CYP3A inhibitor == HIV protease inhibitor
NDA Applicant: ABBVIE INC NDA No.: 207931 Prod. No.: 001 DISC (12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | May 10, 2021 *PED | |
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Feb 25, 2025 *PED | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Feb 25, 2025 *PED | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015 | Oct 10, 2031 *PED | |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
ABBVIE INC
VENCLEXTA (TABLET) (ORAL) VENETOCLAX
Drug Classes: Antineoplastics:Molecular Target Inhibitors == BCL-2 inhibitor
NDA Applicant: ABBVIE INC NDA No.: 208573 Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8546399 DS* DP* Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 4, 2016 | Jun 27, 2031 | |
| Pat. No. 8722657 DS* Salts and crystalline forms of an apoptosis-inducing agent Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Feb 13, 2020 | Jan 29, 2032 | |
| Pat. No. 9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 4, 2016 | May 26, 2030 | U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2445: Treatment in combination with azacitidine or decitabine or low-dose cytarabine of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy U-2446: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
| Pat. No. 9539251 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2019 | Sep 6, 2033 | U-2538: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (Sll) in combination with a GA101 antibody such as obinutuzumab for one or more dosing periods, wherein the CLL or SLL is a CD20-expressing cancer |
| Pat. No. 10730873 DS* Salts and crystalline forms of an apoptosis-inducing agent Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Aug 17, 2020 | Nov 21, 2031 | |
| Pat. No. 10993942 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): All strengths: May 24, 2021 | Sep 6, 2033 | U-3114: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week |
| Pat. No. 11110087 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2021 | Sep 6, 2033 | U-3222: Treatment of acute myeloid leukemia (AML) by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine in adults 75 years or older or having certain comorbidities according to a dose ramp-up including a 100 mg per day dose U-3223: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up including a 100 mg per day dose |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 8, 2021 | I-782: Revisions to indication for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy |
| Exclusivity Code: I - New Indication | Nov 21, 2021 | I-789: Venetoclax in combo with azacitidine or decitabine or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy |
| Exclusivity Code: I - New Indication | May 15, 2022 | I-795: Venetoclax in combination with obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma |
| Exclusivity Code: M - Miscellaneous | Jun 8, 2021 | M-228: Information added to the package insert regarding the revision of the monotherapy indication of venetoclax |
| Exclusivity Code: M - Miscellaneous | Oct 16, 2023 | M-265: Revisions to the labeling to include results from clinical study M15-656 (VIALE-A) and M16-043 (VIALE-C) to support PMR 3545-1 and PMR 3545-2 |
| Exclusivity Code: NCE - New chemical entity | Apr 11, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 11, 2023 | ODE-114: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2025 | ODE-185: Indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2025 | ODE-211: Indicated in combo with azacitidine, or decitabine, or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 15, 2026 | ODE-239: Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
ABBVIE INC
VIEKIRA PAK (COPACKAGED) (TABLET) (ORAL) DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor
NDA Applicant: ABBVIE INC NDA No.: 206619 Prod. No.: 001 DISC (EQ 250MG BASE;12.5MG, 75MG, 50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | May 17, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 10, 2031 | |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 17, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: May 6, 2015 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 1, 2015 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2015 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jun 16, 2017 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 10201542 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Formulation; Method of use; Process; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 14, 2019 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
ABBVIE INC
VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == CYP3A inhibitor == HIV protease inhibitor
NDA Applicant: ABBVIE INC NDA No.: 208624 Prod. No.: 001 DISC (EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | May 17, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 17, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 10, 2030 | U-1687: Treatment of HCV infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 9333204 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 9744170 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 27, 2017 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 10105365 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 10201541 DP* Compositions and methods for treating HCV Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | |
| Pat. No. 10201584 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
ABBVIE INC
VUITY (SOLUTION) (OPHTHALMIC) PILOCARPINE HYDROCHLORIDE
Drug Classes: Dental and Oral Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == cholinergic agonist
NDA Applicant: ABBVIE INC NDA No.: 214028 Prod. No.: 001 RX (1.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10610518 Presbyopia treatments Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 24, 2021 | Apr 24, 2039 | U-3252: Use of VUITY for the treatment of presbyopia in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 28, 2024 |
ABRAXIS BIOSCIENCE
ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: ABRAXIS BIOSCIENCE NDA No.: 021660 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013 | Aug 21, 2026 *PED | U-1434: Treatment of pancreatic cancer |
| Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2010 | Apr 27, 2025 *PED | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2011 | Jun 9, 2024 *PED | U-1117: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Feb 13, 2027 *PED | U-1290: Treatment of lung cancer |
| Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2012 | Jun 9, 2024 *PED | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Aug 21, 2026 *PED | U-1290: Treatment of lung cancer |
| Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2012 | Jun 9, 2024 *PED | U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 8853260 DP* Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2014 | Apr 10, 2021 *PED | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2015 | Aug 21, 2026 *PED | U-1434: Treatment of pancreatic cancer |
| Pat. No. 9393318 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2016 | Sep 4, 2032 *PED | U-1290: Treatment of lung cancer |
| Pat. No. 9511046 Methods of treating pancreatic cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2016 | Jul 12, 2034 *PED | U-1434: Treatment of pancreatic cancer |
| Pat. No. 9597409 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2017 | Sep 4, 2032 *PED | U-1290: Treatment of lung cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 6, 2023 PED | M-14: Additional clinical trial information added to pediatric use subsection |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 6, 2021 PED | ODE-52: Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. |
ACACIA
BARHEMSYS (SOLUTION) (INTRAVENOUS) AMISULPRIDE
Drug Classes: Antiemetics:Antiemetics, Other
NDA Applicant: ACACIA NDA No.: 209510 Prod. No.: 001 RX (5MG/2ML (2.5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9084765 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020 | Mar 10, 2031 | U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting |
| Pat. No. 9545426 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020 | Mar 10, 2031 | U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting |
| Pat. No. 9889118 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020 | Mar 10, 2031 | U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting |
| Pat. No. 10525033 DP* Use of amisulpride as an anti-emetic Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Mar 16, 2020 | Mar 10, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 26, 2025 |
ACACIA
BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA NDA No.: 212295 Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9561236 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Apr 30, 2033 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 9737547 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 9777007 DP* Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Composition Pat. Sub. Date(s): 001: Oct 23, 2020 | Jul 10, 2027 | |
| Pat. No. 9827251 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 9914738 DP* Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Oct 23, 2020 | Jul 10, 2027 | |
| Pat. No. 10052334 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10195210 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10342800 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10472365 Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Jul 10, 2027 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Pat. No. 10722522 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020 | Nov 7, 2031 | U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 6, 2025 |
ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 001 DISC (EQ 17MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6756393 DS* DP* Azacyclic compounds Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 25, 2016 | Mar 6, 2021 | |
| Pat. No. 6815458 DS* DP* Azacyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Mar 6, 2021 | U-1843: Treatment of psychosis |
| Pat. No. 7115634 DS* DP* 4-aminopiperidine and their use as a medicine Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 25, 2016 | Oct 6, 2021 | |
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: May 25, 2016 | Apr 29, 2030 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 25, 2016 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: May 25, 2016 | Jun 3, 2028 | |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 25, 2016 | Sep 26, 2025 | |
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9296694 DS* DP* Azacyclic compounds Claim Types: Compound Pat. Sub. Date(s): 001: May 25, 2016 | Mar 6, 2021 | |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2017 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 4, 2017 | Jul 27, 2022 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 29, 2021 |
ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6756393 DS* DP* Azacyclic compounds Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Jul 25, 2018 | Mar 6, 2021 | |
| Pat. No. 6815458 DS* DP* Azacyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Mar 6, 2021 | U-1843: Treatment of psychosis |
| Pat. No. 7115634 DS* DP* 4-aminopiperidine and their use as a medicine Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Jul 25, 2018 | Oct 6, 2021 | |
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Jul 25, 2018 | Apr 29, 2030 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Jul 25, 2018 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 002: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Jul 25, 2018 | Sep 26, 2025 | |
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9296694 DS* DP* Azacyclic compounds Claim Types: Compound Pat. Sub. Date(s): 002: Jul 25, 2018 | Mar 6, 2021 | |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jul 27, 2022 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 10, 2020 | Mar 23, 2037 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 30, 2021 | Mar 23, 2037 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 29, 2021 |
ACADIA PHARMS INC
NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 210793 Prod. No.: 001 RX (EQ 34MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6756393 DS* DP* Azacyclic compounds Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 6, 2021 | |
| Pat. No. 6815458 DS* DP* Azacyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 6, 2021 | U-1843: Treatment of psychosis |
| Pat. No. 7115634 DS* DP* 4-aminopiperidine and their use as a medicine Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 25, 2018 | Oct 6, 2021 | |
| Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jul 25, 2018 | Apr 29, 2030 | |
| Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jul 25, 2018 | Aug 24, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 25, 2018 | Sep 26, 2025 | |
| Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 9296694 DS* DP* Azacyclic compounds Claim Types: Compound Pat. Sub. Date(s): 001: Jul 25, 2018 | Mar 6, 2021 | |
| Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jul 27, 2022 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10449185 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2019 | Aug 27, 2038 | |
| Pat. No. 10646480 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: May 15, 2020 | Aug 27, 2038 | |
| Pat. No. 10849891 DP* Formulations of pimavanserin Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 11, 2020 | Aug 27, 2038 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 29, 2021 |
ACCORD HLTHCARE
ATROPINE SULFATE (SOLUTION) (INTRAVENOUS) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE NDA No.: 212868 Prod. No.: 001 RX (0.25MG/5ML (0.05MG/ML)); 002 RX (0.5MG/5ML (0.1MG/ML)); 003 RX (1MG/10ML (0.1MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jan 26, 2022 |
ACCORD HLTHCARE
ATROPINE SULFATE (SOLUTION) (INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE NDA No.: 213424 Prod. No.: 001 RX (8MG/20ML (0.4MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Sep 21, 2021 |
ACELRX PHARMS
DSUVIA (TABLET) (SUBLINGUAL) SUFENTANIL CITRATE
Drug Classes: opioid agonist
NDA Applicant: ACELRX PHARMS NDA No.: 209128 Prod. No.: 001 RX (EQ 0.03MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8202535 Small-volume oral transmucosal dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Oct 22, 2030 | U-1351: Treatment of acute pain |
| Pat. No. 8226978 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8231900 DP* Small-volume oral transmucosal dosage Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 8252328 DP* Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 8252329 DP* Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 8535714 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8574189 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms Claim Types: Device Pat. Sub. Date(s): 001: Nov 28, 2018 | Mar 16, 2030 | |
| Pat. No. 8778393 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8778394 Small-volume oral transmucosal dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8865211 Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8865743 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Oct 22, 2030 | U-1351: Treatment of acute pain |
| Pat. No. 8945592 DP* Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same Claim Types: Drug in a container?; Method of reducing drug degration? Pat. Sub. Date(s): 001: Nov 28, 2018 | Jul 29, 2031 | |
| Pat. No. 9320710 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 9744129 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 10245228 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 19, 2019 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 10342762 DP* Small-volume oral transmucosal dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 23, 2019 | Jan 5, 2027 | |
| Pat. No. 10507180 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2020 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 10896751 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms Claim Types: Device Pat. Sub. Date(s): 001: Feb 2, 2021 | Mar 16, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 2, 2021 |
ACERUS
NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ACERUS NDA No.: 205488 Prod. No.: 001 RX (5.5MG/0.122GM ACTUATION)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8574622 DP* Controlled release delivery system for nasal applications Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 26, 2014 | Feb 4, 2024 | |
| Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 20, 2014 | Feb 4, 2024 | |
| Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2014 | Feb 4, 2024 | U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation. |
| Pat. No. 8877230 Controlled release delivery system for nasal applications Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2014 | Feb 4, 2024 | U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 10, 2021 | Mar 17, 2034 | U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone |
ACLARIS
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
NDA Applicant: ACLARIS NDA No.: 209305 Prod. No.: 001 DISC (40%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7381427 Seborrheic keratosis treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 3, 2018 | Jun 8, 2022 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 3, 2018 | Jul 4, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10493103 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2020 | Apr 21, 2035 | |
| Pat. No. 10729720 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 11, 2020 | Apr 21, 2035 |
ACORDA
INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors == aromatic amino acid
NDA Applicant: ACORDA NDA No.: 209184 Prod. No.: 001 RX (42MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43711 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Feb 3, 2029 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 6858199 High efficient delivery of a large therapeutic mass aerosol Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 4, 2021 | U-2485: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles through a single breath activated step |
| Pat. No. 7146978 Inhalation device and method Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Apr 16, 2021 | U-2486: Intermittent treatment of off episodes in patients with Parkinson's Disease with a powder inhaler |
| Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Feb 22, 2024 | |
| Pat. No. 7384649 DP* Particulate compositions for pulmonary delivery Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 20, 2022 | |
| Pat. No. 7556798 Highly efficient delivery of a large therapeutic mass aerosol Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 4, 2021 | U-2485: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles through a single breath activated step |
| Pat. No. 8404276 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 8586093 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 9155699 DP* Pulmonary delivery for levodopa Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | |
| Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 21, 2021 |
ACROTECH
BELEODAQ (POWDER) (INTRAVENOUS) BELINOSTAT
Drug Classes: Antineoplastics:Molecular Target Inhibitors == histone deacetylase (HDAC) inhibitor
NDA Applicant: ACROTECH NDA No.: 206256 Prod. No.: 001 RX (500MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6888027 DS* DP* Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 1, 2014 | Aug 10, 2026 | U-1544: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). |
| Pat. No. 8835501 DP* Pharmaceutical formulations of HDAC inhibitors Claim Types: Formulation; Drug in a container; Kit Pat. Sub. Date(s): 001: Oct 9, 2014 | Oct 27, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 3, 2021 | ODE-68: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
ACROTECH
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ACROTECH NDA No.: 207155 Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Compound; Product-by-process; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016 | Mar 13, 2029 | |
| Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016 | Mar 13, 2029 | |
| Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 14, 2017 | Feb 27, 2033 | |
| Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 6, 2018 | Jan 30, 2034 | |
| Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 15, 2020 | May 28, 2030 | |
| Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 19, 2021 | Jun 14, 2030 | U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma |
| Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2021 | May 28, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 10, 2023 | ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma |
ACROTECH
FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH NDA No.: 022468 Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6028071 DS* DP* [Extended 5 years] Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): All strengths: None | Jul 16, 2022 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 31, 2025 | U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None | May 31, 2025 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
ACROTECH
FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
Drug Classes: Antineoplastics:Treatment Adjuncts == Antineoplastics:Antineoplastics, Other == folate analog
NDA Applicant: ACROTECH NDA No.: 020140 Prod. No.: 001 RX (EQ 50MG BASE/VIAL) NDA No.: 020140 Prod. No.: 002 DISC (EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**); 003 DISC (EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6500829 DS* DP* [Extended 797 days (2.2 years)] Substantially pure diastereoisomers of tetrahydrofolate derivatives Claim Types: Formulation Pat. Sub. Date(s): 001: None; 002: May 9, 2011; 003: May 9, 2011 | Mar 7, 2022 |
ACTELION
OPSUMIT (TABLET) (ORAL) MACITENTAN
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 204410 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7094781 DS* DP* [Extended 1150 days (3.2 years)] Sulfamides and their use as endothelin receptor antagonists Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2013 | Dec 5, 2025 | |
| Pat. No. 8268847 Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013 | Apr 18, 2029 | U-1446: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties |
| Pat. No. 8367685 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013 | Oct 4, 2028 | U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition |
| Pat. No. 9265762 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 16, 2016 | May 29, 2027 | U-1820: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition |
| Pat. No. 10946015 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 8, 2021 | Sep 11, 2026 | U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition |
ACTELION
TRACLEER (TABLET) (ORAL) BOSENTAN [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 021290 Prod. No.: 001 RX (62.5MG); 002 RX (125MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Sep 5, 2024 |
ACTELION
TRACLEER (TABLET, FOR SUSPENSION) (ORAL) BOSENTAN
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 209279 Prod. No.: 001 RX (32MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7959945 DP* Dispersible bosentan tablet Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 3, 2017 | Dec 28, 2027 | |
| Pat. No. 8309126 DP* Dispersible bosentan tablet Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Oct 3, 2017 | May 15, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 5, 2024 | ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability |
ACTELION
UPTRAVI (TABLET) (ORAL) SELEXIPAG
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 207947 Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (0.8MG); 005 RX (1MG); 006 RX (1.2MG); 007 RX (1.4MG); 008 RX (1.6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Oct 31, 2026 | U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag |
| Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 1, 2030 | |
| Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 12, 2029 | U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan |
| Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 12, 2016 | Jun 25, 2030 | U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag |
| Pat. No. 10821108 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020 | Dec 1, 2036 | U-2992: Method of treating pulmonary arterial hypertension comprising administering a solid preparation containing selexipag |
| Pat. No. 10828298 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020 | Dec 1, 2036 | U-2991: Method of treating pulmonary arterial hypertension comprising administering a tablet containing selexipag |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 21, 2022 | ODE-106: For use of UPTRAVI (selexipag) tablets, 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg for treatment of pulmonary arterial hypertension (PAH, WHO group I) to reduce the risks of disease progression and hospitalization for pah |
ACTELION
UPTRAVI (POWDER) (INTRAVENOUS) SELEXIPAG
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 214275 Prod. No.: 001 RX (1.8MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Oct 31, 2026 | U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag |
| Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 27, 2021 | Aug 1, 2030 | |
| Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Aug 12, 2029 | U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan |
| Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Jun 25, 2030 | U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag |
ACTELION
VELETRI (INJECTABLE) (INJECTION) EPOPROSTENOL SODIUM [GENERIC AP2]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacycline vasodilator
NDA Applicant: ACTELION NDA No.: 022260 Prod. No.: 001 RX (EQ 1.5MG BASE/VIAL); 002 RX (EQ 0.5MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318802 DP* Epoprostenol formulation and method of making thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 26, 2012; 002: None | Mar 15, 2027 | |
| Pat. No. 8598227 Epoprostenol formulation and method of making thereof Claim Types: Method of use; Process Pat. Sub. Date(s): All strengths: None | Feb 2, 2027 |
ADAMAS PHARMA
GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents == influenza A M2 protein inhibitor
NDA Applicant: ADAMAS PHARMA NDA No.: 208944 Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Jan 22, 2028 | U-2105: Treatment of dyskinesia in patients with Parkinson's disease receiving immediate release levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8741343 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 9867791 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9867792 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9867793 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9877933 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 30, 2018 | Dec 2, 2030 | U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 10154971 Methods of administering amantadine Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Dec 18, 2018 | Dec 4, 2034 | U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 10646456 Methods of administering amantadine Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jul 14, 2020 | Jun 17, 2034 | U-2808: Treatment of dyskinesia, decreasing off time, and increasing on time without troublesome dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 11065213 DP* Amantadine compositions and preparations thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Jul 20, 2021 | Aug 23, 2038 | |
| Pat. No. 11077073 Methods of using amantadine compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2021 | Aug 23, 2038 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 11197835 Method of administering amantadine prior to a sleep period Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2022 | Dec 2, 2030 | U-3270: U-2106: treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without comcomitant dopaminergic medications |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 24, 2024 | ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications |
ADAMAS PHARMA
OSMOLEX ER (TABLET, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents == influenza A M2 protein inhibitor
NDA Applicant: ADAMAS PHARMA NDA No.: 209410 Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE) NDA No.: 209410 Prod. No.: 003 DISC (EQ 258MG BASE); 004 DISC (EQ 161MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020 | Mar 13, 2030 | |
| Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Jan 22, 2028 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020 | Nov 28, 2025 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 8987333 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | |
| Pat. No. 9072697 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2021 | Nov 23, 2025 | U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease |
| Pat. No. 10213393 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 10213394 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10500170 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment |
| Pat. No. 10500171 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10500172 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
| Pat. No. 10512617 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 2, 2020; 002: Jan 2, 2020; 003: Jan 2, 2020; 004: Oct 29, 2020 | Feb 15, 2038 | U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients |
ADDMEDICA SAS
SIKLOS (TABLET) (ORAL) HYDROXYUREA
Drug Classes: Antineoplastics:Antimetabolites
NDA Applicant: ADDMEDICA SAS NDA No.: 208843 Prod. No.: 001 RX (100MG); 002 RX (1GM)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 21, 2024 | ODE-177: To reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crisis |
ADHERA
PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == dihydropyridine calcium channel blocker == Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == angiotensin converting enzyme inhibitor
NDA Applicant: ADHERA NDA No.: 205003 Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Apr 15, 2023 | U-3: Treatment of hypertension |
| Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Oct 5, 2029 | U-3: Treatment of hypertension |
ADIENNE SA
TEPADINA (POWDER) (INTRACAVITARY, INTRAVENOUS, INTRAVESICAL) THIOTEPA [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA NDA No.: 208264 Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 26, 2024 | ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia |
AERIE PHARMS INC
RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL MESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == Rho kinase inhibitor
NDA Applicant: AERIE PHARMS INC NDA No.: 208254 Prod. No.: 001 RX (EQ 0.02% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Dec 21, 2017 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2018 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2020 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10588901 DS* DP* Combination therapy Claim Types: Formulation; Compound; Method of use Pat. Sub. Date(s): 001: Apr 15, 2020 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jun 10, 2020 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2022 |
AERIE PHARMS INC
ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog == Ophthalmic Agents:Ophthalmic Combinations == Rho kinase inhibitor
NDA Applicant: AERIE PHARMS INC NDA No.: 208259 Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9993470 DS* DP* Combination therapy Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2020 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10588901 DS* DP* Combination therapy Claim Types: Formulation; Compound; Method of use Pat. Sub. Date(s): 001: Apr 15, 2020 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jun 10, 2020 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 | |
| Pat. No. 11197853 DP* Combination therapy Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Mar 12, 2022 | |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2022 |
AGILE
TWIRLA (SYSTEM) (TRANSDERMAL) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Contraceptives:Contraceptives, Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins == progestin-containing intrauterine device (IUD)
NDA Applicant: AGILE NDA No.: 204017 Prod. No.: 001 RX (0.03MG/24HR;0.12MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7045145 DP* Transdermal contraceptive delivery system and process Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 10, 2020 | Mar 14, 2021 | U-2751: A transdermal method of contraception |
| Pat. No. 7384650 DP* Skin permeation enhancement composition for transdermal hormone delivery system Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Mar 10, 2020 | Mar 14, 2021 | |
| Pat. No. 8221784 DP* Transdermal hormone delivery system: compositions and methods Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Mar 10, 2020 | Mar 14, 2021 | |
| Pat. No. 8221785 DP* Transdermal hormone delivery system: compositions and methods Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Mar 10, 2020 | Mar 14, 2021 | |
| Pat. No. 8246978 DP* Dermal delivery device with reduced loss of its volatile components Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Mar 10, 2020 | Aug 26, 2028 | |
| Pat. No. 8747888 DP* Dermal delivery device with in situ seal Claim Types: Device; Formulation Pat. Sub. Date(s): 001: Mar 10, 2020 | Jul 10, 2028 | |
| Pat. No. 9050348 DP* Dermal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Mar 10, 2020 | Jul 10, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 14, 2023 |
AKARX INC
DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents
NDA Applicant: AKARX INC NDA No.: 210238 Prod. No.: 001 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2018 | May 5, 2025 | |
| Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 30, 2023 | U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment |
| Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 15, 2018 | Jan 15, 2023 | U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 26, 2022 | I-802: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
| Exclusivity Code: NCE - New chemical entity | May 21, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 26, 2026 | ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
AKCEA THERAPS
TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == transthyretin-directed antisense oligonucleotide
NDA Applicant: AKCEA THERAPS NDA No.: 211172 Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7015315 DS* Gapped oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Mar 21, 2023 | |
| Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Sep 5, 2023 | |
| Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 1, 2025 | |
| Pat. No. 8697860 DP* Diagnosis and treatment of disease Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9061044 DS* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9399774 Modulation of transthyretin expression Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 5, 2025 | ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
AKORN
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: AKORN NDA No.: 022221 Prod. No.: 001 RX (3.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2014 | Jul 24, 2026 | U-1523: Method of inducing topical anesthesia in the eye |
AKORN
XOPENEX (SOLUTION) (INHALATION) LEVALBUTEROL HYDROCHLORIDE [GENERIC AN]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: AKORN NDA No.: 020837 Prod. No.: 001 RX (EQ 0.021% BASE); 002 RX (EQ 0.042% BASE); 003 RX (EQ 0.0103% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6451289 Albuterol formulations Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): All strengths: None | Mar 21, 2021 |
AKORN
XOPENEX (SOLUTION) (INHALATION) LEVALBUTEROL HYDROCHLORIDE [GENERIC AN]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: AKORN NDA No.: 020837 Prod. No.: 004 RX (EQ 0.25% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6451289 DP* Albuterol formulations Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 004: None | Mar 21, 2021 |
AKORN
ZIOPTAN (SOLUTION/DROPS) (OPHTHALMIC) TAFLUPROST [GENERIC AT]
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: AKORN NDA No.: 202514 Prod. No.: 001 RX (0.0015%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5886035 DS* DP* [Extended 5 years] Difluoroprostaglandin derivatives and their use Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Feb 27, 2012 | Dec 18, 2022 | U-778: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 9999593 DP* Method and composition for treating ocular hypertension and glaucoma Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2018 | May 28, 2029 | |
| Pat. No. 10864159 DP* Method and composition for treating ocular hypertension and glaucoma Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2021 | May 28, 2029 | U-778: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
ALBIREO
BYLVAY (CAPSULE, PELLETS) (ORAL) ODEVIXIBAT
NDA Applicant: ALBIREO NDA No.: 215498 Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (1.2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7132416 DS* DP* Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia Claim Types: Compound; Process; Composition Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Sep 5, 2022 | |
| Pat. No. 9694018 IBAT inhibitors for the treatment of liver disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10011633 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10093697 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10487111 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Pat. No. 10975046 DS* Crystal modifications of odevixibat Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Jun 20, 2039 | |
| Pat. No. 10981952 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021 | Nov 8, 2031 | U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 20, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 20, 2028 | ODE-363: Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC) |
ALCON LABS INC
PATADAY ONCE DAILY RELIEF (SOLUTION/DROPS) (OPHTHALMIC) OLOPATADINE HYDROCHLORIDE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 206276 Prod. No.: 001 OTC (EQ 0.7% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8791154 DP* High concentration olopatadine ophthalmic composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 31, 2015 | May 19, 2032 | U-1680: Treatment of ocular itching associated with allergic conjunctivitis |
| Pat. No. 9533053 DP* High concentration olopatadine ophthalmic composition Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 31, 2020 | May 19, 2032 |
ALCON LABS INC
SIMBRINZA (SUSPENSION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == carbonic anhydrase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 204251 Prod. No.: 001 RX (0.2%;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2015 | Oct 30, 2030 | |
| Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2016 | Jun 17, 2030 |
ALCON PHARMS LTD
NAVSTEL (SOLUTION) (IRRIGATION) CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
NDA Applicant: ALCON PHARMS LTD NDA No.: 022193 Prod. No.: 001 DISC (0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7084130 DP* Intraocular irrigating solution having improved flow characteristics Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Nov 29, 2021 | U-891: Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye |
ALEMBIC PHARMS LTD
ASENAPINE MALEATE (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALEMBIC PHARMS LTD NDA No.: 206098 Prod. No.: 002 RX (EQ 10MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Jun 8, 2021 |
ALEMBIC PHARMS LTD
TIMOLOL MALEATE (SOLUTION, GEL FORMING/DROPS) (OPHTHALMIC) TIMOLOL MALEATE [GENERIC AB]
Drug Classes: Antimigraine Agents:Antimigraine Agents, Other == Cardiovascular Agents:Beta-adrenergic Blocking Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == beta-adrenergic receptor inhibitor
NDA Applicant: ALEMBIC PHARMS LTD NDA No.: 212942 Prod. No.: 001 RX (EQ 0.25% BASE); 002 RX (EQ 0.5% BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | May 24, 2021 |
ALEOR DERMACEUTICALS
MUPIROCIN (CREAM) (TOPICAL) MUPIROCIN CALCIUM [GENERIC AB]
Drug Classes: Dermatological Agents:Topical Anti-infectives == RNA synthetase inhibitor antibacterial
NDA Applicant: ALEOR DERMACEUTICALS NDA No.: 213053 Prod. No.: 001 RX (EQ 2% BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jun 27, 2022 |
ALEOR DERMACEUTICALS
TAVABOROLE (SOLUTION) (TOPICAL) TAVABOROLE [GENERIC AB]
Drug Classes: Dermatological Agents:Topical Anti-infectives == oxaborole antifungal
NDA Applicant: ALEOR DERMACEUTICALS NDA No.: 212188 Prod. No.: 001 RX (5%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Apr 17, 2021 |
ALEXZA PHARMS
ADASUVE (POWDER) (INHALATION) LOXAPINE
Drug Classes: Antipsychotics:1st Generation/Typical
NDA Applicant: ALEXZA PHARMS NDA No.: 022549 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | May 20, 2022 | |
| Pat. No. 7052679 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7078020 DP* Delivery of antipsychotics through an inhalation route Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | U-1375: ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults |
| Pat. No. 7090830 DP* Drug condensation aerosols and kits Claim Types: Kit; Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Aug 18, 2024 | |
| Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 28, 2024 | |
| Pat. No. 7585493 DP* Thin-film drug delivery article and method of use Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7601337 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Jul 25, 2022 | |
| Pat. No. 8173107 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8235037 DP* Drug condensation aerosols and kits Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 23, 2026 | |
| Pat. No. 8955512 DP* Method of forming an aerosol for inhalation delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 18, 2015 | Oct 26, 2021 | |
| Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Apr 29, 2015 | May 21, 2024 | |
| Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016 | May 20, 2024 | |
| Pat. No. 9439907 DP* Method of forming an aerosol for inhalation delivery Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 13, 2016 | Oct 26, 2021 | |
| Pat. No. 9440034 DP* Drug condensation aerosols and kits Claim Types: Formulation; Kit; Method of administration Pat. Sub. Date(s): 001: Oct 13, 2016 | Oct 26, 2021 | |
| Pat. No. 9687487 DS* DP* Aerosol forming device for use in inhalation therapy Claim Types: Device Pat. Sub. Date(s): 001: Jul 14, 2017 | Oct 26, 2021 |
ALIMERA SCIENCES INC
ILUVIEN (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Dermatological Agents:Dermatological Agents, Other == Otic Agents:Otic Glucocorticoids == corticosteroid
NDA Applicant: ALIMERA SCIENCES INC NDA No.: 201923 Prod. No.: 001 RX (0.19MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8871241 DP* Injectable sustained release delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Nov 12, 2014 | Aug 12, 2027 |
ALK ABELLO
OTIPRIO (INJECTABLE, SUSPENSION) (OTIC) CIPROFLOXACIN
Drug Classes: Antibacterials:Quinolones == Ophthalmic Agents:Ophthalmic Anti-Infectives == Otic Agents:Otic Anti-Infectives == Otic Agents:Otic Combinations == quinolone antimicrobial
NDA Applicant: ALK ABELLO NDA No.: 207986 Prod. No.: 001 RX (6% (60MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318817 Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 11, 2016 | Apr 27, 2030 | U-1792: Treatment of otic infection or inflammation |
| Pat. No. 9205048 Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 11, 2016 | Apr 21, 2029 | U-1793: Treatment of pediatric patients with otitis media with effusion undergoing tympanostomy tube placement |
| Pat. No. 9220796 DP* Sterilization of ciprofloxacin composition Claim Types: Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Jan 11, 2016 | Jul 1, 2035 | |
| Pat. No. 9233068 DP* Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2016 | Dec 11, 2029 | |
| Pat. No. 9603796 DS* DP* Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 26, 2018 | Apr 21, 2029 | U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus |
| Pat. No. 11040004 Otic gel formulations for treating otitis externa Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2021 | Nov 12, 2037 | U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 2, 2021 | I-770: Treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus |
ALKEM LABS LTD
MORPHINE SULFATE (TABLET) (ORAL) MORPHINE SULFATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ALKEM LABS LTD NDA No.: 212451 Prod. No.: 001 RX (15MG); 002 RX (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Aug 10, 2021 |
ALKERMES
VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) NALTREXONE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: ALKERMES NDA No.: 021897 Prod. No.: 001 RX (380MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7919499 Naltrexone long acting formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: May 16, 2011 | Oct 15, 2029 | U-1123: Treatment of alcohol dependence U-1124: Prevention of relapse to opioid dependence, following opioid detoxification |
ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 10, 2020 | Mar 19, 2035 | U-2983: Treatment of schizophrenia by rapid and continuous injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 002: Oct 14, 2015 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 14, 2015 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 14, 2015 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Dec 9, 2015 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 002: Oct 5, 2016 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): 002: Jan 19, 2017 | Mar 19, 2035 | |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): 002: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 002: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 10, 2020 | Mar 19, 2035 | U-2983: Treatment of schizophrenia by rapid and continuous injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 003: Oct 14, 2015 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 14, 2015 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 14, 2015 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Dec 9, 2015 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 003: Oct 5, 2016 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): 003: Jan 19, 2017 | Mar 19, 2035 | |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): 003: Apr 8, 2019 | Mar 19, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): 003: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): 003: Nov 10, 2020 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 003: Oct 21, 2021 | Oct 24, 2033 | U-764: Treatment of schizophrenia |
ALKERMES INC
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 209830 Prod. No.: 001 RX (675MG/2.4ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jul 18, 2018 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 18, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10016415 DP* Aripiprazole prodrug compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 18, 2018 | Sep 8, 2035 | |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10688091 DP* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 8, 2020 | Aug 17, 2035 | |
| Pat. No. 10849894 Aripiprazole prodrug composition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2020 | Aug 17, 2035 | U-543: Treatment of schizophrenia |
| Pat. No. 11154552 DP* Aripiprazole prodrug composition Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2021 | Aug 17, 2035 |
ALKERMES INC
LYBALVI (TABLET) (ORAL) OLANZAPINE; SAMIDORPHAN L-MALATE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic == opioid antagonist
NDA Applicant: ALKERMES INC NDA No.: 213378 Prod. No.: 001 RX (5MG;EQ 10MG BASE); 002 RX (10MG;EQ 10MG BASE); 003 RX (15MG;EQ 10MG BASE); 004 RX (20MG;EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7262298 DS* 4-hydroxybenzomorphans Claim Types: Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Nov 23, 2025 | |
| Pat. No. 7956187 DS* Method for decreasing opioid metabolism Claim Types: Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Oct 31, 2021 | |
| Pat. No. 8252929 DS* 8-carboxamido-2,6-methano-3-benzazocines Claim Types: Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Oct 31, 2021 | |
| Pat. No. 8778960 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Feb 13, 2032 | U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain |
| Pat. No. 9119848 DS* Morphinan derivatives for the treatment of drug overdose Claim Types: Method of use; Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 30, 2031 | |
| Pat. No. 9126977 DP* Methods for treating antipsychotic-induced weight gain Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain |
| Pat. No. 9517235 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3138: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile U-3139: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile |
| Pat. No. 10300054 DP* Methods for treating antipsychotic-induced weight gain Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan U-3141: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan |
| Pat. No. 10716785 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021 | Aug 23, 2031 | U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain |
| Pat. No. 11185541 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 22, 2021 | Aug 23, 2031 | U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 28, 2026 |
ALLERGAN
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN NDA No.: 021528 Prod. No.: 001 RX (0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011 | Nov 24, 2027 *PED | U-1181: A method of treating or preventing ocular pain in a patient |
| Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012 | Nov 28, 2024 *PED | U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient |
| Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013 | Nov 28, 2024 *PED | U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery |
| Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013 | Nov 28, 2024 *PED | U-1441: A method of treating or reducing ocular pain and burning/stinging |
| Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014 | May 28, 2024 | |
| Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015 | May 28, 2024 | U-1626: A method of treating or preventing ocular pain and burning |
| Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015 | May 28, 2024 | U-1662: A method of treating ocular pain |
| Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | May 28, 2024 | U-1800: A method of treating ocular pain and/or enhancing ocular comfort |
ALLERGAN
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN NDA No.: 022427 Prod. No.: 001 RX (0.45%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Aug 15, 2029 | |
| Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013 | Mar 7, 2028 | |
| Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015 | Aug 5, 2024 | |
| Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Mar 7, 2028 |
ALLERGAN
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
ALLERGAN
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021770 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2014 | Mar 2, 2024 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2017 | Jan 10, 2022 *PED | |
| Pat. No. 10307368 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 24, 2019 | Jul 10, 2021 |
ALLERGAN
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == Antibacterials:Beta-lactam, Cephalosporins == cephalosporin antibacterial
NDA Applicant: ALLERGAN NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jan 7, 2026 | U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium U-282: Method of treating bacterial infections |
| Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Nov 12, 2026 | |
| Pat. No. 8178554 DS* DP* Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jul 24, 2021 | U-2245: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering an effective amount of avibactam sodium U-2509: A method of treating a bacterial infection in complicated intra-abdominal infection (CIAI) and complicated urinary tract infection (CUTI), including pyelonephritis, patients comprising administering an effective amount of avibactam sodium U-282: Method of treating bacterial infections |
| Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Mar 17, 2015 | Aug 12, 2031 | |
| Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Oct 8, 2030 | |
| Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Mar 17, 2015 | Jun 15, 2032 | |
| Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 24, 2017 | Jun 15, 2032 | |
| Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Formulation; Compound; Composition Pat. Sub. Date(s): 001: Aug 8, 2017 | Jun 15, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: GAIN - Generating Antibiotic Incentives Now | Feb 25, 2025 |
ALLERGAN
BYSTOLIC (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN NDA No.: 021742 Prod. No.: 002 RX (EQ 2.5MG BASE); 003 RX (EQ 5MG BASE); 004 RX (EQ 10MG BASE); 005 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6545040 DP* [Extended 618 days (1.7 years)] Method of lowering the blood pressure Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Dec 17, 2021 | U-3: Treatment of hypertension |
ALLERGAN
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Drug Classes: Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor == Cardiovascular Agents:Angiotensin II Receptor Antagonists == Cardiovascular Agents:Cardiovascular Combinations == angiotensin II receptor blocker
NDA Applicant: ALLERGAN NDA No.: 206302 Prod. No.: 001 DISC (EQ 5MG BASE;80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7803838 DP* Compositions comprising nebivolol Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 5, 2016 | Aug 29, 2026 | |
| Pat. No. 7838552 Compositions comprising nebivolol Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 5, 2016 | Oct 4, 2027 | U-185: Method of treating hypertension |
ALLERGAN
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: Inflammatory Bowel Disease Agents:Aminosalicylates and/ or Prodrugs
NDA Applicant: ALLERGAN NDA No.: 021252 Prod. No.: 002 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8217083 DP* Mesalamine suppository Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2013 | Jun 6, 2028 | |
| Pat. No. 8436051 DP* Mesalamine suppository Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2013 | Jun 6, 2028 |
ALLERGAN
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == Antimigraine Agents:Antimigraine Agents, Other == Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN NDA No.: 021398 Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP |
| Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 2, 2012 | Apr 19, 2022 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Mar 27, 2013 | Apr 19, 2022 | U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma |
| Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 7, 2014 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2016 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2017 | Apr 19, 2022 | U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid |
ALLERGAN
DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: Antibacterials:Antibacterials, Other == lipoglycopeptide antibacterial
NDA Applicant: ALLERGAN NDA No.: 021883 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6900175 Methods of administering dalbavancin for treatment of bacterial infections Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014 | Dec 25, 2023 | U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin. |
| Pat. No. 7115564 DP* Stable pharmaceutical compositions of dalbavancin and methods of administration Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | |
| Pat. No. 7119061 DP* Dalbavancin compositions for treatment of bacterial infections Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | |
| Pat. No. 8143212 Dalbavancin compositions for treatment of bacterial infections Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: GAIN - Generating Antibiotic Incentives Now | May 23, 2024 | |
| Exclusivity Code: NCE - New chemical entity | May 23, 2019 | |
| Exclusivity Code: NPP - New patient population | Jul 22, 2024 |
ALLERGAN
FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN NDA No.: 204168 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 80MG BASE); 004 RX (EQ 120MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43879 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Jan 11, 2026 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8481598 Stable dosage forms of levomilnacipran Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Mar 2, 2031 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Nov 20, 2014 | May 23, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 7, 2022 | M-249: Information added to the labeling to describe study LVM-MD-15 to fulfill postmarketing commitment 1943-4 |
ALLERGAN
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == muscarinic antagonist
NDA Applicant: ALLERGAN NDA No.: 022204 Prod. No.: 001 RX (10% (100MG/PACKET))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8920392 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Drug in a container; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 27, 2015 | Mar 26, 2031 | U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin |
| Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 16, 2016 | Nov 6, 2029 | U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin |
| Pat. No. 10449173 DP* Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 30, 2019 | Nov 6, 2029 | U-2637: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence with a single unit dose of 10% oxybutynin chloride gel |
ALLERGAN
GELNIQUE 3% (GEL, METERED) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == muscarinic antagonist
NDA Applicant: ALLERGAN NDA No.: 202513 Prod. No.: 001 DISC (3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 27, 2012 | Jun 25, 2022 |
ALLERGAN
LASTACAFT (SOLUTION/DROPS) (OPHTHALMIC) ALCAFTADINE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == histamine-1 (H1) receptor antagonist
NDA Applicant: ALLERGAN NDA No.: 022134 Prod. No.: 001 OTC (0.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8664215 Ocular allergy treatments with alcaftadine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2014 | Dec 23, 2027 | U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander |
| Pat. No. 10617695 DP* Ophthalmic compositions containing alcaftadine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 12, 2020 | Mar 19, 2027 | U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander |
ALLERGAN
LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: ALLERGAN NDA No.: 022369 Prod. No.: 001 RX (0.03%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8038988 DS* DP* Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 31, 2011 | Aug 25, 2023 | U-1208: Treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness |
| Pat. No. 8101161 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012 | May 25, 2024 | U-1217: Method of increasing hair growth U-1218: Method of stimulating hair growth |
| Pat. No. 8263054 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2012 | Jan 15, 2023 | U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin |
| Pat. No. 8541466 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 27, 2015 | Jan 31, 2021 | U-1217: Method of increasing hair growth |
| Pat. No. 8632760 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2014 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 8758733 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 16, 2014 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 8906962 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2014 | Jan 31, 2021 | U-1217: Method of increasing hair growth |
| Pat. No. 8986715 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 1, 2015 | Jan 15, 2023 | U-1217: Method of increasing hair growth |
| Pat. No. 9216183 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 9226931 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | Jan 15, 2023 | U-1799: Method of increasing growth of hair including eyelashes |
| Pat. No. 9579270 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2017 | Jan 31, 2021 | U-1975: Method of increasing eyelash growth with bimatoprost |
ALLERGAN
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == Anxiolytics:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ALLERGAN NDA No.: 021323 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6916941 DS* DP* Crystalline composition containing escitalopram Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation Pat. Sub. Date(s): All strengths: None | Feb 12, 2023 *PED | |
| Pat. No. 7420069 DP* Crystalline composition containing escitalopram Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Feb 12, 2023 *PED |
ALLERGAN
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN NDA No.: 202811 Prod. No.: 001 RX (145MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
ALLERGAN
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN NDA No.: 202811 Prod. No.: 002 RX (290MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 002: None | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 002: None | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. |
ALLERGAN
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN NDA No.: 202811 Prod. No.: 003 RX (72MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Aug 30, 2026 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Feb 17, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Aug 10, 2017 | Aug 16, 2033 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 10675325 DP* Stable formulations of linaclotide Claim Types: Composition Pat. Sub. Date(s): 003: Jun 22, 2020 | Aug 11, 2031 | |
| Pat. No. 10702576 Stable formulations of linaclotide Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 4, 2020 | Aug 11, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
ALLERGAN
LUMIGAN (SOLUTION/DROPS) (OPHTHALMIC) BIMATOPROST
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: ALLERGAN NDA No.: 022184 Prod. No.: 001 RX (0.01%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7851504 DS* DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jun 13, 2027 | |
| Pat. No. 8278353 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2012 | Mar 16, 2025 | |
| Pat. No. 8299118 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012 | Mar 16, 2025 | U-1295: A method of treating a patient with glaucoma or ocular hypertension |
| Pat. No. 8309605 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012 | Mar 16, 2025 | U-1293: A method of lowering intraocular pressure in a patient with open angle glaucoma or ocular hypertension U-1294: Method of treating glaucoma in a patient |
| Pat. No. 8338479 DP* Enhanced bimatoprost ophthalmic solution Claim Types: ;Composition; Method of administration Pat. Sub. Date(s): 001: Dec 26, 2012 | Mar 16, 2025 | U-1295: A method of treating a patient with glaucoma or ocular hypertension |
| Pat. No. 8524777 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013 | Mar 16, 2025 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8586630 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 16, 2025 | U-1458: A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 8772338 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2014 | Mar 16, 2025 | U-1528: A method of lowering intraocular pressure |
| Pat. No. 8933120 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 10, 2015 | Mar 16, 2025 | |
| Pat. No. 8933127 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 10, 2015 | Mar 16, 2025 | |
| Pat. No. 9155716 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | Mar 16, 2025 | U-1528: A method of lowering intraocular pressure |
| Pat. No. 9241918 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 24, 2016 | Mar 16, 2025 | U-1814: Method of treating glaucoma or elevated intraocular pressure |
ALLERGAN
NAMENDA XR (CAPSULE, EXTENDED RELEASE) (ORAL) MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidementia Agents:N-methyl-D-aspartate (NMDA) Receptor Antagonist == Antidementia Agents:Antidementia Agents, Other
NDA Applicant: ALLERGAN NDA No.: 022525 Prod. No.: 001 RX (7MG); 002 RX (14MG); 003 RX (21MG); 004 RX (28MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2011; 002: None; 003: None; 004: None | Sep 24, 2029 *PED | U-539: Treatment of moderate to severe dementia of the Alzheimer's type |
ALLERGAN
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: Antidementia Agents:Cholinesterase Inhibitors == Antidementia Agents:N-methyl-D-aspartate (NMDA) Receptor Antagonist == Antidementia Agents:Antidementia Agents, Other
NDA Applicant: ALLERGAN NDA No.: 206439 Prod. No.: 001 RX (10MG;14MG); 002 RX (10MG;28MG); 003 RX (10MG;7MG); 004 RX (10MG;21MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: None; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Sep 24, 2029 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED |
ALLERGAN
OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: ALLERGAN NDA No.: 022315 Prod. No.: 001 RX (0.7MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6899717 Methods and apparatus for delivery of ocular implants Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Nov 1, 2023 | U-1206: Delivering an ocular implant as described in the dosage and administration section of the approved labeling of OZURDEX |
| Pat. No. 7767223 DP* Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use Claim Types: Formulation Pat. Sub. Date(s): 001: None | Nov 28, 2021 | |
| Pat. No. 8034366 DP* Ocular implant made by a double extrusion process Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 23, 2011 | Jan 9, 2023 | U-1204: Treatment of uveitis U-1205: Treatment of macular edema |
| Pat. No. 8034370 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 23, 2011 | Jan 9, 2023 | |
| Pat. No. 8506987 Ocular implant made by a double extrusion process Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 11, 2013 | Jan 9, 2023 | U-1204: Treatment of uveitis U-1205: Treatment of macular edema |
| Pat. No. 9192511 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Jan 9, 2023 | |
| Pat. No. 10076526 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 17, 2018 | Jan 9, 2023 | |
| Pat. No. 10702539 Ocular implant made by a double extrusion process Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 7, 2020 | Jan 9, 2023 | U-1597: Treatment of diabetic macular edema U-2868: Treatment of non-infectious uveitis affecting the posterior segment of the eye U-985: Treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) |
ALLERGAN
RESTASIS (EMULSION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other == calcineurin inhibitor immunosuppressant
NDA Applicant: ALLERGAN NDA No.: 050790 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8629111 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 14, 2014 | Aug 27, 2024 | |
| Pat. No. 8633162 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2014 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8642556 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 4, 2014 | Aug 27, 2024 | |
| Pat. No. 8648048 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 11, 2014 | Aug 27, 2024 | U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8685930 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 1, 2014 | Aug 27, 2024 | |
| Pat. No. 9248191 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 2, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
ALLERGAN
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other == calcineurin inhibitor immunosuppressant
NDA Applicant: ALLERGAN NDA No.: 050790 Prod. No.: 002 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8292129 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 25, 2031 | |
| Pat. No. 8561859 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 16, 2032 | |
| Pat. No. 8629111 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8633162 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8642556 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8648048 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8685930 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 9248191 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 9669974 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | May 11, 2034 | |
| Pat. No. 9676525 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 7, 2034 |
ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Oct 6, 2026 *PED | U-1064: Treatment of bipolar disorder and schizophrenia U-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult) U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults |
| Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jul 29, 2014 | Oct 6, 2026 *PED |
ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 003 RX (EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 003: Sep 12, 2016 | Oct 6, 2026 *PED | U-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17 |
| Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 003: Sep 12, 2016 | Oct 6, 2026 *PED |
ALLERGAN
SAVELLA (TABLET) (ORAL) MILNACIPRAN HYDROCHLORIDE
Drug Classes: Central Nervous System Agents:Fibromyalgia Agents == serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN NDA No.: 022256 Prod. No.: 001 RX (12.5MG); 002 RX (25MG); 003 RX (50MG); 004 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6602911 [Extended 435 days (1.2 years)] Methods of treating fibromyalgia Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 14, 2023 | U-882: Management of fibromyalgia (FM) |
| Pat. No. 6992110 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Nov 5, 2021 | U-882: Management of fibromyalgia (FM) |
| Pat. No. 7888342 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 15, 2011; 002: None; 003: None; 004: None | Nov 5, 2021 | U-882: Management of fibromyalgia (FM) |
| Pat. No. 7994220 Milnacipran for the long-term treatment of fibromyalgia syndrome Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None; 004: None | Sep 19, 2029 | U-819: Management of fibromyalgia |
ALLERGAN
TEFLARO (POWDER) (INTRAVENOUS) CEFTAROLINE FOSAMIL [GENERIC AP]
Drug Classes: Antibacterials:Beta-lactam, Cephalosporins == cephalosporin antibacterial
NDA Applicant: ALLERGAN NDA No.: 200327 Prod. No.: 001 RX (400MG/VIAL); 002 RX (600MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6417175 DS* DP* [Extended 1211 days (3.3 years)] Phosphonocephem derivatives, process for the preparation of the same, and use thereof Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Apr 11, 2022 | U-1676: Methods for treating bacterial infections |
| Pat. No. 6906055 DS* DP* Phosphonocephem compound Claim Types: Compound; Composition; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Dec 15, 2021 | |
| Pat. No. 7419973 DP* Phosphonocephem compound Claim Types: Composition Pat. Sub. Date(s): All strengths: None | Dec 15, 2021 | |
| Pat. No. 8247400 DP* Cephem compounds useful for the treatment of bacterial infections Claim Types: Compound; Composition; Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Feb 10, 2031 | U-282: Method of treating bacterial infections |
| Pat. No. 9629861 DP* Compositions and methods for treating bacterial infections using ceftaroline Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 17, 2017 | Sep 21, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Sep 13, 2022 |
ALLERGAN
UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: Antimigraine Agents:Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
NDA Applicant: ALLERGAN NDA No.: 211765 Prod. No.: 001 RX (50MG); 002 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jan 21, 2020 | Jul 19, 2032 | U-2717: Acute treatment of migraine with headache, with or without aura in adults |
| Pat. No. 8912210 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jan 21, 2020 | Nov 10, 2031 | |
| Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jan 21, 2020 | Nov 10, 2031 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 9833448 Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 21, 2020 | Nov 10, 2031 | U-2718: Acute treatment of migraine with or without aura in adults |
| Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 21, 2020 | Jan 30, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 23, 2024 |
ALLERGAN
VIIBRYD (TABLET) (ORAL) VILAZODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
NDA Applicant: ALLERGAN NDA No.: 022567 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7834020 DS* DP* Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride Claim Types: New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): 001: Jan 25, 2011; 002: None; 003: None | Dec 5, 2022 *PED | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8193195 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 14, 2012 | Dec 5, 2022 *PED | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8236804 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 14, 2012; 002: None; 003: None | Dec 5, 2022 *PED | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8673921 DS* DP* Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Mar 21, 2014 | Dec 5, 2022 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jul 31, 2023 PED | M-254: Information added to the labeling regarding pediatric patients ages 7 to 17 years of age with major depressive disorder |
ALLERGAN
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 204370 Prod. No.: 001 RX (EQ 1.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47350 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): 001: May 15, 2019 | Jul 16, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine |
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): 001: Oct 16, 2015 | Sep 17, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 001: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 24, 2022 | I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) |
ALLERGAN
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 204370 Prod. No.: 002 RX (EQ 3MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): 002: Oct 16, 2015 | Sep 17, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 002: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 24, 2022 | I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) |
ALLERGAN
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 204370 Prod. No.: 003 RX (EQ 4.5MG BASE); 004 RX (EQ 6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): All strengths: Oct 16, 2015 | Sep 17, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 24, 2022 | I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) |
ALLERGAN HOLDINGS
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents == mu-opioid receptor agonist
NDA Applicant: ALLERGAN HOLDINGS NDA No.: 206940 Prod. No.: 001 RX (75MG); 002 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741356 DS* DP* Compounds as opioid receptor modulators Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jun 26, 2015 | May 27, 2029 | |
| Pat. No. 7786158 DS* Compounds as opioid receptor modulators Claim Types: Compound Pat. Sub. Date(s): All strengths: Jun 26, 2015 | Mar 14, 2025 | |
| Pat. No. 8344011 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 26, 2015 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8609709 DS* Compounds as opioid receptor modulators Claim Types: Compound; New polymorph, salt, or hydrate Pat. Sub. Date(s): All strengths: Jun 26, 2015 | Mar 14, 2025 | |
| Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl Claim Types: New polymorph, salt, or hydrate; Method of use Pat. Sub. Date(s): All strengths: Jun 26, 2015 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8772325 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 16, 2017 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): All strengths: Sep 23, 2015 | Jul 7, 2028 | U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline) |
| Pat. No. 9205076 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 30, 2015 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 14, 2016 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 7, 2017 | Mar 14, 2033 | |
| Pat. No. 9700542 DP* Compounds as opioid receptor modulators Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Aug 7, 2017 | Mar 14, 2025 | |
| Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Nov 1, 2017 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 28, 2019 | Mar 14, 2033 | |
| Pat. No. 10213415 DS* Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 21, 2019 | Mar 14, 2025 | U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 3, 2021 | Mar 14, 2033 | |
| Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 7, 2021 | Mar 14, 2033 | |
| Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 24, 2021 | Mar 14, 2033 |
ALLERGAN INC
DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: ALLERGAN INC NDA No.: 211911 Prod. No.: 001 RX (10MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7799336 DP* Hypotensive lipid-containing biodegradable intraocular implants and related methods Claim Types: Device; Product-by-process Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 24, 2029 | |
| Pat. No. 8206737 Hypotensive lipid-containing biodegradable intraocular implants and related methods Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 7, 2027 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 8629185 DS* DP* 7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 24, 2020 | Jul 15, 2031 | |
| Pat. No. 8673341 Intraocular pressure reduction with intracameral bimatoprost implants Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Feb 19, 2025 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 9149428 DP* Processes for making cyclic lipid implants for intraocular use Claim Types: Device Pat. Sub. Date(s): 001: Mar 24, 2020 | Dec 19, 2026 | |
| Pat. No. 9492316 DP* Prostamide-containing intraocular implants and methods of use thereof Claim Types: Device; Method of use; Process Pat. Sub. Date(s): 001: Mar 24, 2020 | Oct 31, 2034 | |
| Pat. No. 9980974 Prostamide-containing intraocular implants and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Oct 31, 2034 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 10398707 Hypotensive lipid-containing biodegradable intraocular implants and related implants Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2020 | Apr 30, 2024 | U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant |
| Pat. No. 10441543 DP* Processes for making cyclic lipid implants for intraocular use Claim Types: Device Pat. Sub. Date(s): 001: Mar 24, 2020 | Dec 19, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 4, 2023 |
ALMATICA
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone
NDA Applicant: ALMATICA NDA No.: 022497 Prod. No.: 001 RX (450MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7674479 DP* Sustained-release bupropion and bupropion/mecamylamine tablets Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2011 | Jun 25, 2027 |
ALMATICA
GRALISE (TABLET) (ORAL) GABAPENTIN [Has competitive generic]
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents == Central Nervous System Agents:Central Nervous System, Other == antiepileptic drug (AED)
NDA Applicant: ALMATICA NDA No.: 022544 Prod. No.: 001 RX (300MG); 002 RX (600MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6723340 DP* Optimal polymer mixtures for gastric retentive tablets Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Oct 25, 2021 | |
| Pat. No. 7438927 Methods of treatment using a gastric retained gabapentin dosage Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Feb 26, 2024 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
| Pat. No. 7731989 DP* Gastric retained gabapentin dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Oct 25, 2022 | |
| Pat. No. 8192756 DP* Gastric retained gabapentin dosage form Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: Jun 8, 2012 | Oct 25, 2022 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
| Pat. No. 8252332 DP* Gastric retained gabapentin dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 17, 2012; 002: None | Oct 25, 2022 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
| Pat. No. 8333992 DP* Gastric retained gabapentin dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 17, 2013; 002: None | Oct 25, 2022 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
ALMATICA
LOREEV XR (CAPSULE, EXTENDED RELEASE) (ORAL) LORAZEPAM
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents == Anxiolytics:Benzodiazepines
NDA Applicant: ALMATICA NDA No.: 214826 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8999393 DP* Sustained release formulations of lorazepam Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Sep 22, 2021 | Jan 8, 2034 | U-3210: Once daily treatment of anxiety disorder in adults |
ALMIRALL
ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: Antimycobacterials:Antimycobacterials, Other == Dermatological Agents:Topical Anti-infectives == sulfone
NDA Applicant: ALMIRALL NDA No.: 207154 Prod. No.: 001 RX (7.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016 | Nov 18, 2033 | |
| Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2016 | Nov 18, 2033 | U-1033: Topical treatment of acne vulgaris |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Sep 10, 2022 |
ALMIRALL
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: Dermatological Agents:Topical Anti-infectives == pleuromutilin antibacterial
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43390 DS* DP* Pleuromutilin derivatives as antimicrobials Claim Types: Compound; Process; Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 9, 2012 | Apr 12, 2021 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
| Pat. No. 7875630 DS* Process salts compositions and use Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: Feb 10, 2011 | Feb 14, 2027 | |
| Pat. No. 8207191 Process, salts, composition and use Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2016 | Aug 30, 2024 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
ALMIRALL
KLISYRI (OINTMENT) (TOPICAL) TIRBANIBULIN
NDA Applicant: ALMIRALL NDA No.: 213189 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7300931 DS* DP* Compositions for treating cell proliferation disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 12, 2021 | Feb 6, 2026 | |
| Pat. No. 7851470 DS* DP* Composition and methods for modulating a kinase cascade Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 12, 2021 | Feb 2, 2029 | U-3015: Topical treatment of actinic keratosis of the face or scalp |
| Pat. No. 8236799 DS* DP* Biaryl compositions and methods for modulating a kinase cascade Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 12, 2021 | Dec 28, 2025 | |
| Pat. No. 8980890 DS* DP* Compositions and methods of treating cell proliferation disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jan 12, 2021 | Dec 28, 2025 | |
| Pat. No. 10323001 DP* Compositions for modulating a kinase cascade and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 12, 2021 | Dec 28, 2027 | |
| Pat. No. 10617693 Methods of treating and/or preventing actinic keratosis Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Jan 12, 2021 | Mar 12, 2038 | U-3015: Topical treatment of actinic keratosis of the face or scalp |
| Pat. No. 10669236 DS* DP* Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jan 12, 2021 | Sep 7, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 14, 2025 |
ALMIRALL
SEYSARA (TABLET) (ORAL) SARECYCLINE HYDROCHLORIDE
Drug Classes: Antibacterials:Tetracyclines == tetracycline-class drug
NDA Applicant: ALMIRALL NDA No.: 209521 Prod. No.: 001 RX (EQ 60MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318706 DS* DP* Substituted tetracycline compounds Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Oct 12, 2018 | May 1, 2031 | U-2405: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride |
| Pat. No. 8513223 Substituted tetracycline compounds for treatment of inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Dec 7, 2029 | U-2406: A method for treating a patient 9 years of age and older suffering from an inflammatory skin disorder of non-nodular moderate to severe acne vulgaris comprising administering an effective amount of sarecycline hydrochloride |
| Pat. No. 9255068 DS* DP* Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(met- hyl)amino)-methyl] acid amide and methods of using the same Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Feb 9, 2033 | U-2407: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt U-2408: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt |
| Pat. No. 9481639 Substituted tetracycline compounds for treatment of inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Aug 10, 2028 | U-2409: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering sarecycline hydrochloride in 60 mg, 100 mg or 150 mg equivalent doses |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 1, 2023 |
ALMIRALL
VERDESO (AEROSOL, FOAM) (TOPICAL) DESONIDE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == corticosteroid
NDA Applicant: ALMIRALL NDA No.: 021978 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8460641 DP* Microemulsion process and composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 5, 2013 | Aug 13, 2027 | U-1412: Treatment of atopic dermatitis |
| Pat. No. 8962000 DP* Microemulsion and sub-micron emulsion process and compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 25, 2015 | Aug 31, 2025 | U-1412: Treatment of atopic dermatitis |
| Pat. No. 9492384 DP* Microemulsion and sub-micron emulsion process and compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 19, 2016 | Aug 31, 2025 | U-1412: Treatment of atopic dermatitis |
ALNYLAM PHARMS INC
GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 212194 Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 12, 2029 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8546143 DS* Compositions and methods for inhibiting expression of a target gene Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jan 9, 2022 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Dec 4, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9133461 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | May 14, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 28, 2025 | |
| Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jan 1, 2024 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 9708615 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Dec 12, 2019 | Oct 3, 2034 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 15, 2033 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Aug 24, 2028 | U-2672: Treatment of acute hepatic porphyria |
| Pat. No. 10273477 DS* Therapeutic compositions Claim Types: Compound Pat. Sub. Date(s): 001: Dec 12, 2019 | Mar 8, 2024 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 20, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 20, 2026 | ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP) |
ALNYLAM PHARMS INC
ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 210922 Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8058069 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | |
| Pat. No. 8158601 DP* Lipid formulation Claim Types: Compound; Composition; Formulation; Method of administration Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 10, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8168775 DS* DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Compound; Composition; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8334373 DS* DP* Nuclease resistant double-stranded ribonucleic acid Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Sep 6, 2018 | May 27, 2025 | |
| Pat. No. 8362231 DS* DP* RNA interference mediating small RNA molecules Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | |
| Pat. No. 8372968 DS* DP* RNA interference mediating small RNA molecules Claim Types: Compound; Product-by-process; Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | |
| Pat. No. 8492359 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | |
| Pat. No. 8552171 DS* DP* RNA sequence-specific mediators of RNA interference Claim Types: Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | |
| Pat. No. 8642076 DP* Lipid containing formulations Claim Types: Compound; Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 3, 2027 | |
| Pat. No. 8741866 Compositions and methods for inhibiting expression of transthyretin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8778902 RNA interference mediating small RNA molecules Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8802644 DP* Lipid formulation Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 21, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8822668 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8895718 DS* DP* RNA interference mediating small RNA molecules Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | |
| Pat. No. 8895721 DS* DP* RNA interference mediating small RNA molecules Claim Types: Composition; Product-by-process Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | |
| Pat. No. 9193753 RNA sequence-specific mediators of RNA interference Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9234196 DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Formulation; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9364435 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9567582 DS* DP* RNA interference mediating small RNA molecules Claim Types: Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Mar 30, 2021 | |
| Pat. No. 9943538 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations Claim Types: Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 4, 2023 | |
| Pat. No. 9943539 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations Claim Types: Composition Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 4, 2023 | |
| Pat. No. 10240152 DS* DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Formulation claimed by its inherent performace characteristics; Method of Use claimed by its inherent performace characteristics; Composition Pat. Sub. Date(s): 001: Sep 3, 2021 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 11079379 DS* DP* Methods of treating transthyretin (TTR) mediated amyloidosis Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 3, 2021 | Aug 27, 2035 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 11141378 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 9, 2021 | Apr 15, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 10, 2025 | ODE-197: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
ALNYLAM PHARMS INC
OXLUMO (SOLUTION) (SUBCUTANEOUS) LUMASIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 214103 Prod. No.: 001 RX (EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 12, 2029 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 4, 2028 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 9828606 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | |
| Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents Claim Types: Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Aug 24, 2028 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10435692 Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10465195 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10478500 DS* DP* Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Oct 9, 2035 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10487330 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10612024 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 10, 2020 | Aug 14, 2035 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 10612027 DS* DP* Modified double-stranded RNA agents Claim Types: Compound; Composition; Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 10, 2020 | Aug 14, 2035 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Pat. No. 11060093 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2021 | Dec 26, 2034 | U-2995: Treatment of primary hyperoxaluria type 1 (PH1) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 23, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 23, 2027 | ODE-339: Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients |
ALPHARMA PHARMS
EMBEDA (CAPSULE, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: ALPHARMA PHARMS NDA No.: 022321 Prod. No.: 001 DISC (20MG;0.8MG); 002 DISC (30MG;1.2MG); 003 DISC (50MG;2MG); 004 DISC (60MG;2.4MG); 005 DISC (80MG;3.2MG); 006 DISC (100MG;4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7682633 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed. |
| Pat. No. 7682634 DP* Pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | |
| Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 19, 2010; 002: None; 003: None; 004: None; 005: None; 006: None | Dec 12, 2027 | |
| Pat. No. 8158156 Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed. |
| Pat. No. 8623418 Pharmaceutical composition Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jan 22, 2015 | Nov 7, 2029 | U-1640: Treatment of moderate to severe chronic pain by administering an intact composition as claimed |
| Pat. No. 8685443 Sequestering subunit and related compositions and methods Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | U-1508: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed |
| Pat. No. 8685444 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | |
| Pat. No. 8846104 DP* Pharmaceutical compositions for the deterrence and/or prevention of abuse Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 28, 2014 | Jun 19, 2027 | |
| Pat. No. 8877247 DP* Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jun 19, 2027 |
ALTATHERA PHARMS LLC
SOTALOL HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) SOTALOL HYDROCHLORIDE
Drug Classes: Cardiovascular Agents:Antiarrhythmics
NDA Applicant: ALTATHERA PHARMS LLC NDA No.: 022306 Prod. No.: 001 RX (150MG/10ML (15MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10512620 Method of initiating and escalating sotalol hydrochloride dosing Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 26, 2020 | Aug 18, 2038 | U-2769: Dosing regimen for intravenous sotalol for administration in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation. |
| Pat. No. 10799138 Method of administering sotalol IV/switch Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2021 | Apr 5, 2039 | U-3125: Use for loading dose in patients with symptomatic Afib/AFL who are currently in sinus rhythm or for the treatment of life-threatening ventricular tachycardia |
ALTHERA PHARMS
ROSZET (TABLET) (ORAL) EZETIMIBE; ROSUVASTATIN CALCIUM
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == Cardiovascular Agents:Cardiovascular Combinations == dietary cholesterol absorption inhibitor == Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == HMG CoA-reductase inhibitor
NDA Applicant: ALTHERA PHARMS NDA No.: 213072 Prod. No.: 001 RX (10MG;EQ 5MG BASE); 002 RX (10MG;EQ 10MG BASE); 003 RX (10MG;EQ 20MG BASE); 004 RX (10MG;EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9763885 DP* Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Mar 29, 2021 | May 1, 2033 | U-3095: Treatment of hyperlipidemia |
| Pat. No. 10376470 DP* Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: Mar 29, 2021 | May 1, 2033 | U-3095: Treatment of hyperlipidemia |
ALVOGEN
PYRIMETHAMINE (TABLET) (ORAL) PYRIMETHAMINE [GENERIC AB]
Drug Classes: Antiparasitics:Antiprotozoals == dihydrofolate reductase inhibitor antimalarial
NDA Applicant: ALVOGEN NDA No.: 211271 Prod. No.: 001 RX (25MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Apr 2, 2022 |
AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 5, 2024 | |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 15, 2028 | U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 17, 2014 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less |
| Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 18, 2016 | Oct 20, 2023 | |
| Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2021 | Oct 20, 2023 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 |
AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Feb 2, 2021 | Feb 5, 2024 | |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 2, 2021 | Feb 15, 2028 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Feb 2, 2021 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less |
| Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Feb 2, 2021 | Oct 20, 2023 | |
| Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Oct 14, 2021 | Oct 20, 2023 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 |
AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 003 RX (1GM IRON/20ML (50MG IRON/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 003: May 21, 2021 | Feb 5, 2024 | |
| Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: May 21, 2021 | Feb 15, 2028 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 003: May 21, 2021 | Jan 8, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less |
| Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Compound; Composition Pat. Sub. Date(s): 003: May 21, 2021 | Oct 20, 2023 | |
| Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Claim Types: Product-by-process; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Oct 14, 2021 | Oct 20, 2023 | U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 19, 2024 | |
| Exclusivity Code: NS - New strength | Apr 28, 2024 |
AM REGENT
SELENIOUS ACID (SOLUTION) (INTRAVENOUS) SELENIOUS ACID
NDA Applicant: AM REGENT NDA No.: 209379 Prod. No.: 001 RX (EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)); 002 RX (EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)); 003 RX (EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Apr 30, 2024 |
AM REGENT
TRALEMENT; MULTRYS (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT NDA No.: 209376 Prod. No.: 001 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)); 002 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)); 003 RX (EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Apr 30, 2024 |
AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other
NDA Applicant: AMARIN PHARMS NDA No.: 202057 Prod. No.: 001 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8293727 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8293728 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 29, 2030 | |
| Pat. No. 8314086 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8318715 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 29, 2012 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8357677 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8367652 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 7, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8377920 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8399446 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8410086 Compositions and methods for lowering triglycerides Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Jun 15, 2030 | U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy |
| Pat. No. 8415335 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 17, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8426399 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8431560 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8440650 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | < |