Orange Book Companion (R)
What's New for Vol. 44, Supp. 11
Changes to patent and exclusivity information

In the What's New that logged-in subscribers see, the tradename of each drug is a link to the full patent/exclusivity portfolio of the drug. If you would like that have that very useful feature, please subscribe! It is only $295/year for your whole company or organization! Click the link at the top of this page for more info.

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


ACTHAR GEL (AUTOINJECTOR) (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: MALLINCKRODT ARD      NDA No.:
008372  Prod. No.: 003 RX (40 UNITS/0.5ML); 004 RX (80 UNITS/ML); 008 RX (80 UNITS/ML)
PatentsExpirationChange
Pat. No. 11752199
Methods of modulating pericytes
Pat. Sub. Date(s): 003: Jul 31, 2024; 004: Jul 31, 2024; 008: Sep 21, 2023
Claim Types: Method of use
Use Code: U-3686: Treatment of exacerbations of multiple sclerosis in adults with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering
Use Code: U-3687: Treatment of infantile spasms with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering
Use Code: U-3688: Treatment of ophthalmic diseases with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering
Feb 25, 2041New patent for this product

AMELUZ (GEL) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
NDA Applicant: BIOFRONTERA      NDA No.:
208081  Prod. No.: 001 RX (10%)
ExclusivityExpirationChange
Exclusivity Code: D - New Dosing Schedule: D-194: Increase in the approved dosage regimen to a maximum application area of 60 cm^2 in total (corresponding to three 2 gm tubes)Oct 4, 2027New exclusivity for this product

APONVIE (EMULSION) (INTRAVENOUS) APREPITANT
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: HERON THERAPS INC      NDA No.:
216457  Prod. No.: 001 RX (32MG/4.4ML (7.2MG/ML))
PatentsExpirationChange
Pat. No. 12115254 DP*
Methods of use of emulsion formulations of an NK-1 receptor antagonist
Pat. Sub. Date(s): 001: Nov 7, 2024
Claim Types: Formulation
Sep 18, 2035New patent for this product
Pat. No. 12115255 DP*
Methods of use of emulsion formulations of an NK-1 receptor antagonist
Pat. Sub. Date(s): 001: Nov 7, 2024
Claim Types: Formulation
Sep 18, 2035New patent for this product

APRETUDE (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand
NDA Applicant: VIIV HLTHCARE      NDA No.:
215499  Prod. No.: 001 RX (600MG/3ML (200MG/ML))
PatentsExpirationChange
Pat. No. 12138264 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): 001: Dec 5, 2024
Claim Types: Formulation; Dosaage regimen; Method of use
Sep 15, 2031New patent for this product

ARAZLO (LOTION) (TOPICAL) TAZAROTENE
Drug Classes: retinoid
NDA Applicant: BAUSCH      NDA No.:
211882  Prod. No.: 001 RX (0.045%)
PatentsExpirationChange
Pat. No. 12128137 DP*
Topical compositions and methods for treating skin diseases
Pat. Sub. Date(s): 001: Nov 8, 2024
Claim Types: Method of use; Formulation
Use Code: U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older
May 11, 2038New patent for this product

AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME      NDA No.:
215430  Prod. No.: 001 RX (105MG;45MG)
PatentsExpirationChange
Pat. No. 12146889
Compounds and combinations thereof for treating neurological and psychiatric conditions
Pat. Sub. Date(s): 001: Nov 20, 2024
Claim Types: Method of use; Dosaage regimen
Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Feb 23, 2043New patent for this product

AZMIRO (SOLUTION) (INTRAMUSCULAR) TESTOSTERONE CYPIONATE
Drug Classes: androgen
NDA Applicant: AZURITY      NDA No.:
216318  Prod. No.: 001 RX (200MG/ML (200MG/ML))
PatentsExpirationChange
Pat. No. 12138271 DP*
Pharmaceutical compositions of testosterone
Pat. Sub. Date(s): 001: Nov 14, 2024
Claim Types: Formulation; Drug in a container; Formulation claimed by its inherent performace characteristics
Mar 25, 2039New patent for this product

BAXDELA (POWDER) (INTRAVENOUS) DELAFLOXACIN MEGLUMINE
Drug Classes: fluoroquinolone antibacterial
NDA Applicant: MELINTA      NDA No.:
208611  Prod. No.: 001 RX (EQ 300MG BASE/VIAL)
PatentsExpirationChange
Pat. No. 12138257 DP*
Antimicrobial compositions
Pat. Sub. Date(s): 001: Nov 14, 2024
Claim Types: Composition; New polymorph, salt or hydrate; Formulation
May 1, 2032New patent for this product

BEIZRAY (SOLUTION) (INTRAVENOUS) DOCETAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: ZHUHAI      NDA No.:
218711  Prod. No.: 001 RX (80MG/4ML (20MG/ML))
PatentsExpirationChange
Pat. No. 11419842 DP*
Neutral pH compositions of Docetaxel and human serum albumin
Pat. Sub. Date(s): 001: Nov 13, 2024
Claim Types: Formulation; Method of use
Use Code: U-4027: Treatment of gastric adenocarcinoma
Use Code: U-4028: Treatment of head and neck cancer
Use Code: U-881: Treatment of non-small cell lung cancer
Use Code: U-937: Treatment of prostate cancer
Use Code: U-946: Treatment of breast cancer
May 16, 2036New patent for this product
Pat. No. 12090134 DP*
Neutral pH compositions of docetaxel and human serum albumin
Pat. Sub. Date(s): 001: Nov 13, 2024
Claim Types: Product-by-process; Method of use
Use Code: U-4027: Treatment of gastric adenocarcinoma
Use Code: U-4028: Treatment of head and neck cancer
Use Code: U-881: Treatment of non-small cell lung cancer
Use Code: U-937: Treatment of prostate cancer
Use Code: U-946: Treatment of breast cancer
May 16, 2036New patent for this product
Pat. No. 12090135 DP*
Neutral pH compositions of docetaxel and human serum albumin
Pat. Sub. Date(s): 001: Nov 13, 2024
Claim Types: Process
May 16, 2036New patent for this product

BRIDION (SOLUTION) (INTRAVENOUS) SUGAMMADEX SODIUM [GENERIC AP]
NDA Applicant: MSD SUB MERCK      NDA No.:
022225  Prod. No.: 001 RX (EQ 500MG BASE/5ML (EQ 100MG BASE/ML)); 002 RX (EQ 200MG BASE/2ML (EQ 100MG BASE/ML))
PatentsExpirationChange
Pat. No. RE44733 DS* DP*
6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block
Pat. Sub. Date(s): All strengths: Jan 12, 2016
Claim Types: Compound; Composition; Kit; Method of use
Use Code: U-1794: Reversal of drug-induced neuromuscular block
Jul 27, 2026 *PEDNew expiration date. Was previously Jan 27, 2026

CABENUVA KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR; RILPIVIRINE
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
212888  Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))
PatentsExpirationChange
Pat. No. 12138264 DP*
Pharmaceutical compositions
Pat. Sub. Date(s): All strengths: Dec 5, 2024
Claim Types: Formulation; Dosaage regimen; Method of use
Use Code: U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg
Sep 15, 2031New patent for this product

CABOMETYX (TABLET) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: kinase inhibitor
NDA Applicant: EXELIXIS INC      NDA No.:
208692  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 60MG BASE)
PatentsExpirationChange
Pat. No. 12128039 DP*
Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Pat. Sub. Date(s): All strengths: Nov 25, 2024
Claim Types: Composition; Method of use
Use Code: U-1220: Treatment of renal cell carcinoma
Use Code: U-1480: Treatment of advanced renal cell carcinoma
Use Code: U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Use Code: U-3225: Treatment of differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy
Feb 10, 2032New patent for this product

CABTREO (GEL) (TOPICAL) ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Drug Classes: retinoid == lincosamide antibacterial
NDA Applicant: BAUSCH      NDA No.:
216632  Prod. No.: 001 RX (0.15%;3.1%;1.2%)
PatentsExpirationChange
Pat. No. 12128059 DP*
Topical compositions
Pat. Sub. Date(s): 001: Nov 8, 2024
Claim Types: Formulation; Method of use; Process
Use Code: U-3713: Topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older
Jul 31, 2040New patent for this product
Pat. No. 12133859 DP*
Topical compositions
Pat. Sub. Date(s): 001: Nov 22, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Jul 31, 2040New patent for this product
Pat. No. 12138278 DP*
Topical compositions
Pat. Sub. Date(s): 001: Dec 6, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Jul 31, 2040New patent for this product

CAMCEVI KIT (EMULSION) (SUBCUTANEOUS) LEUPROLIDE MESYLATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ACCORD      NDA No.:
211488  Prod. No.: 001 RX (EQ 42MG BASE)
PatentsExpirationChange
Pat. No. 12133878 DP*
Pharmaceutical compositions having a selected release duration
Pat. Sub. Date(s): 001: Nov 12, 2024
Claim Types: Formulation
Dec 18, 2037New patent for this product

CEPHALEXIN (TABLET) (ORAL) CEPHALEXIN [GENERIC AB]
Drug Classes: cephalosporin antibacterial
NDA Applicant: AUROBINDO PHARMA LTD      NDA No.:
218817  Prod. No.: 001 RX (EQ 250MG BASE); 002 RX (EQ 500MG BASE)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Apr 9, 2025New exclusivity for this product

CINVANTI (EMULSION) (INTRAVENOUS) APREPITANT
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: HERON THERAPS INC      NDA No.:
209296  Prod. No.: 001 RX (130MG/18ML (7.2MG/ML))
PatentsExpirationChange
Pat. No. 12115254 DP*
Methods of use of emulsion formulations of an NK-1 receptor antagonist
Pat. Sub. Date(s): 001: Nov 7, 2024
Claim Types: Formulation
Sep 18, 2035New patent for this product
Pat. No. 12115255 DP*
Methods of use of emulsion formulations of an NK-1 receptor antagonist
Pat. Sub. Date(s): 001: Nov 7, 2024
Claim Types: Formulation
Sep 18, 2035New patent for this product

CLOMIPHENE CITRATE (TABLET) (ORAL) CLOMIPHENE CITRATE [GENERIC AB]
Drug Classes: estrogen agonist/antagonist
NDA Applicant: APPCO      NDA No.:
216739  Prod. No.: 001 RX (50MG)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy May 18, 2025New product in Orange Book

COMETRIQ (CAPSULE) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: kinase inhibitor
NDA Applicant: EXELIXIS      NDA No.:
203756  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 80MG BASE)
PatentsExpirationChange
Pat. No. 12128039 DP*
Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Pat. Sub. Date(s): All strengths: Nov 25, 2024
Claim Types: Composition; Method of use
Use Code: U-1617: Method of treating medullary thyroid cancer
Feb 10, 2032New patent for this product

CREXONT (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX      NDA No.:
217186  Prod. No.: 001 RX (35MG;140MG); 002 RX (52.5MG;210MG); 003 RX (70MG;280MG); 004 RX (87.5MG;350MG)
PatentsExpirationChange
Pat. No. 12128141 DP*
Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof
Pat. Sub. Date(s): All strengths: Nov 13, 2024
Claim Types: Formulation; Method of use
Use Code: U-219: Treatment of Parkinson's disease
Oct 7, 2034New patent for this product

DANZITEN (TABLET) (ORAL) NILOTINIB TARTRATE
Drug Classes: kinase inhibitor
NDA Applicant: AZURITY      NDA No.:
219293  Prod. No.: 001 RX (EQ 71MG BASE); 002 RX (EQ 95MG BASE)
PatentsExpirationChange
Pat. No. 10874671 DP*
Pharmaceutical compositions of nilotinib
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: Composition; Product-by-process; Formulation; Kit; Formulation claimed by its inherent performace characteristics
Feb 18, 2040New product in Orange Book
Pat. No. 11793809 DP*
Pharmaceutical compositions of nilotinib
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: Formulation
Feb 18, 2040New product in Orange Book

DELSTRIGO (TABLET) (ORAL) DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == nucleoside analogue human immunodeficiency virus (HIV-1) reverse == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)
NDA Applicant: MSD MERCK CO      NDA No.:
210807  Prod. No.: 001 RX (100MG;300MG;300MG)
PatentsExpirationChange
Pat. No. 8486975 DS* DP*
Non-nucleoside reverse transcriptase inhibitors
Pat. Sub. Date(s): 001: Sep 17, 2018
Claim Types: Compound; Composition; Method of use
Use Code: U-2395: For the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history
Use Code: U-2629: Treatment of HIV-1 infection in adult patients as a replacement therapy in virologically suppressed adults with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO
Use Code: U-3307: Treatment of HIV-1 infection in pediatric patients weighing at least 35kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed
Aug 30, 2032New expiration date. Was previously Oct 7, 2031

EMROSI (CAPSULE, EXTENDED RELEASE) (ORAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: DR REDDYS      NDA No.:
219015  Prod. No.: 001 RX (40MG)
PatentsExpirationChange
Pat. No. 10905664
Methods for treating inflammatory skin conditions
Pat. Sub. Date(s): 001: Nov 25, 2024
Claim Types: Method of use
Use Code: U-4043: EMROSI is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults
Jan 7, 2039New product in Orange Book
Pat. No. 11191740
Methods for treating inflammatory skin conditions
Pat. Sub. Date(s): 001: Nov 25, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-4043: EMROSI is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults
Jan 7, 2039New product in Orange Book
Pat. No. 11364212
Methods for treating inflammatory skin conditions
Pat. Sub. Date(s): 001: Nov 25, 2024
Claim Types: Method of use
Use Code: U-4043: EMROSI is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults
Jan 7, 2039New product in Orange Book

EVRYSDI (FOR SOLUTION) (ORAL) RISDIPLAM
Drug Classes: survival of motor neuron 2 (SMN2) splicing modifier
NDA Applicant: GENENTECH INC      NDA No.:
213535  Prod. No.: 001 RX (0.75MG/ML)
PatentsExpirationChange
Pat. No. 12122789 DS* DP*
Forms of pyrido[1,2-a]pyrimidin-4-one derivatives, its formulation and its process of making
Pat. Sub. Date(s): 001: Nov 12, 2024
Claim Types: New polymorph, salt or hydrate; Composition; Kit
Apr 15, 2041New patent for this product

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationChange
Pat. No. 12144890 DP*
Manufacturing of bupivacaine multivesicular liposomes
Pat. Sub. Date(s): All strengths: Nov 20, 2024
Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics; Method of use
Use Code: U-4033: Method of providing local or regional analgesia, for example, via infiltration to provide postsurgical local analgesia or via interscalene brachial plexus nerve block to provide postsurgical regional analgesia
Jan 22, 2041New patent for this product
Pat. No. 12151024 DP*
Manufacturing Of Bupivacaine Multivesicular Liposomes
Pat. Sub. Date(s): All strengths: Nov 26, 2024
Claim Types: Product-by-process
Use Code: U-4037: Method of treating pain, for example, via infiltration to provide local analgesia or via interscalene brachial plexus nerve block to provide regional analgesia
Jan 22, 2041New patent for this product
Pat. No. 12156940 DP*
Manufacturing Of Bupivacaine Multivesicular Liposomes
Pat. Sub. Date(s): All strengths: Dec 3, 2024
Claim Types: Formulation claimed by its inherent performace characteristics
Jul 2, 2044New patent for this product

EYSUVIS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: ALCON LABS INC      NDA No.:
210933  Prod. No.: 001 RX (0.25%)
PatentsExpirationChange
Pat. No. 12115246 DP*
Compositions and methods for ophthalmic and/or other applications
Pat. Sub. Date(s): 001: Nov 8, 2024
Claim Types: Formulation; Method of use
Use Code: U-2985: A method for treating dry eye in a patient
May 3, 2033New patent for this product

FYARRO (POWDER) (INTRAVENOUS) SIROLIMUS
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: AADI      NDA No.:
213312  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationChange
Pat. No. 12133844
Methods of treating epithelioid cell tumors
Pat. Sub. Date(s): 001: Dec 4, 2024
Claim Types: Method of use
Use Code: U-4040: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose administered on days 1 and 8 of a 21-day cycle
Use Code: U-4041: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose of 45 mg/m2 or 56 mg/m2 administered on days 1 and 8 of a 21-day cycle
Use Code: U-4042: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose of 45 mg/m2 administered on days 1 and 8 of a 21-day cycle
Jun 29, 2036New patent for this product

GLYXAMBI (TABLET) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
206073  Prod. No.: 001 RX (10MG;5MG); 002 RX (25MG;5MG)
PatentsExpirationChange
Pat. No. 12115179
Pharmaceutical composition, methods for treating and uses thereof
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Method of use
Use Code: U-4023: Treatment of type 2 diabetes mellitus by administration of empagliflozin, linagliptin and metformin
Feb 11, 2030New patent for this product

IGALMI (FILM) (BUCCAL, SUBLINGUAL) DEXMEDETOMIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: BIOXCEL      NDA No.:
215390  Prod. No.: 001 RX (EQ 0.12MG BASE); 002 RX (EQ 0.18MG BASE)
PatentsExpirationChange
Pat. No. 12138247
Non-sedating dexmedetomidine treatment regimens
Pat. Sub. Date(s): All strengths: Nov 13, 2024
Claim Types: Method of use
Use Code: U-4029: Acute treatment of agitation in patients with severe hepatic impairment
Jan 12, 2043New patent for this product

IMKELDI (SOLUTION) (ORAL) IMATINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: SHORLA ONCOLOGY      NDA No.:
219097  Prod. No.: 001 RX (EQ 80MG BASE/ML)
PatentsExpirationChange
Pat. No. 11957681 DP*
Liquid dosage forms of Imatinib
Pat. Sub. Date(s): 001: Nov 27, 2024
Claim Types: Formulation
Apr 27, 2040New product in Orange Book

IMVEXXY (INSERT) (VAGINAL) ESTRADIOL
Drug Classes: estrogen
NDA Applicant: MAYNE PHARMA      NDA No.:
208564  Prod. No.: 001 RX (0.004MG)
PatentsExpirationChange
Pat. No. 9180091 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 001: Jun 19, 2018
Claim Types: Formulation; Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Dec 20, 2033
Pat. No. 10258630
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 001: Apr 18, 2019
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Dec 20, 2033
Pat. No. 10398708
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 001: Sep 12, 2019
Claim Types: Method of use
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Use Code: U-2614: Treatment of moderate to severe dyspareunia
Nov 21, 2032New expiration date. Was previously Dec 20, 2033
Pat. No. 10471072
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 001: Dec 6, 2019
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 10568891
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 001: Mar 19, 2020
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 10668082
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 001: Jun 10, 2020
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 10888516
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 001: Feb 8, 2021
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 11065197 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 001: Aug 5, 2021
Claim Types: Formulation
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 11116717 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 001: Sep 24, 2021
Claim Types: Product-by-process; Formulation
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 11123283 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 001: Sep 24, 2021
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 11497709
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032This patent is no longer listed for this product

IMVEXXY (INSERT) (VAGINAL) ESTRADIOL
Drug Classes: estrogen
NDA Applicant: MAYNE PHARMA      NDA No.: 208564  Prod. No.: 002 RX (0.01MG)
PatentsExpirationChange
Pat. No. 9180091 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 002: Jun 19, 2018
Claim Types: Formulation; Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Dec 20, 2033
Pat. No. 10258630
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 002: Apr 18, 2019
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Dec 20, 2033
Pat. No. 10398708
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 002: Sep 12, 2019
Claim Types: Method of use
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Use Code: U-2614: Treatment of moderate to severe dyspareunia
Nov 21, 2032New expiration date. Was previously Dec 20, 2033
Pat. No. 10471072
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 002: Dec 6, 2019
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 10568891
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 002: Mar 19, 2020
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 10668082
Vaginal inserted estradiol pharmaceutical compositions and methods
Pat. Sub. Date(s): 002: Jun 10, 2020
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 10888516
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 002: Feb 8, 2021
Claim Types: Method of use
Use Code: U-2316: Treatment of dyspareunia
Use Code: U-2317: Treatment of a symptom of vulvar and vaginal atrophy
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 11065197 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 002: Aug 5, 2021
Claim Types: Formulation
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 11116717 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 002: Sep 24, 2021
Claim Types: Product-by-process; Formulation
Nov 21, 2032New expiration date. Was previously Jun 18, 2033
Pat. No. 11123283 DP*
Soluble estradiol capsule for vaginal insertion
Pat. Sub. Date(s): 002: Sep 24, 2021
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Nov 21, 2032New expiration date. Was previously Jun 18, 2033

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.:
203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
PatentsExpirationChange
Pat. No. 7754702
Methods and compositions for administration of iron
Pat. Sub. Date(s): 001: Sep 12, 2013
Claim Types: Method of use
Use Code: U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex
Use Code: U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Use Code: U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
Use Code: U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose
Use Code: U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Feb 15, 2028New Use Code; Deleted Use Code(s): U-2555, U-2556, U-2557
Pat. No. 8895612
Methods and compositions for administration of iron
Pat. Sub. Date(s): 001: Dec 17, 2014
Claim Types: Method of use; Method of administration
Use Code: 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.
Use Code: 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
Use Code: 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
Use Code: U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
Use Code: U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less
Use Code: U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about <=15 min
Jan 8, 2027New Use Code; Deleted Use Code(s): U-3050, U-3051

INVELTYS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: ALCON LABS INC      NDA No.:
210565  Prod. No.: 001 RX (1%)
PatentsExpirationChange
Pat. No. 12115246 DP*
Compositions and methods for ophthalmic and/or other applications
Pat. Sub. Date(s): 001: Nov 8, 2024
Claim Types: Formulation; Method of use
Use Code: U-4025: A method for the treatment of post-operative inflammation following ocular surgery
May 3, 2033New patent for this product

ITOVEBI (TABLET) (ORAL) INAVOLISIB
NDA Applicant: GENENTECH INC      NDA No.:
219249  Prod. No.: 001 RX (3MG); 002 RX (9MG)
PatentsExpirationChange
Pat. No. 8242104 DS* DP*
Benzoxazepin P13K inhibitor compounds and methods of use
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: Compound; Composition; Process; Kit
Sep 27, 2030New patent for this product
Pat. No. 8343955
Benzoxazepin PI3K inhibitor compounds and methods of use
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: Method of use
Use Code: U-4024: Combination with palbociclib and fulvestrant for treatment of adults with endocrine-resistant pik3ca-mutated hr-positive HER2-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy
Sep 27, 2030New patent for this product
Pat. No. 9650393 DS* DP*
Benzoxazepin oxazolidinone compounds and methods of use
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: Compound; Composition; Process; Method of use; Kit
Use Code: U-4024: Combination with palbociclib and fulvestrant for treatment of adults with endocrine-resistant pik3ca-mutated hr-positive HER2-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy
Jul 1, 2036New patent for this product
Pat. No. 10851091 DS* DP*
Benzoxazepin oxazolidinone compounds and methods of use
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: Compound; Composition
Jul 1, 2036New patent for this product
Pat. No. 11028100 DS* DP*
Polymorphs and solid forms of (s)-2-((2-((s)-4-(difluoromethyl)-2-oxooxazolidin-3-yl)-5,6-dihydrobenzo[f]imidazo[1,2-d][1,4]oxazepin-9-yl)amino)propanamide, and methods of production
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: New polymorph, salt or hydrate; Composition
Apr 26, 2038New patent for this product
Pat. No. 11760753
Benzoxazepin oxazolidinone compounds and methods of use
Pat. Sub. Date(s): All strengths: Nov 8, 2024
Claim Types: Method of use
Use Code: U-4024: Combination with palbociclib and fulvestrant for treatment of adults with endocrine-resistant pik3ca-mutated hr-positive HER2-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy
Jul 1, 2036New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Oct 10, 2029New exclusivity for this product

JARDIANCE (TABLET) (ORAL) EMPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
204629  Prod. No.: 001 RX (10MG); 002 RX (25MG)
PatentsExpirationChange
Pat. No. 12115179
Pharmaceutical composition, methods for treating and uses thereof
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Method of use
Use Code: U-4023: Treatment of type 2 diabetes mellitus by administration of empagliflozin, linagliptin and metformin
Feb 11, 2030New patent for this product

KLOXXADO (SPRAY) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: HIKMA      NDA No.:
212045  Prod. No.: 001 RX (8MG/SPRAY)
PatentsExpirationChange
Pat. No. 11975096 DP*
Liquid naloxone spray
Pat. Sub. Date(s): 001: Dec 4, 2024
Claim Types: Formulation
Aug 26, 2034New patent for this product

LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS      NDA No.:
214755  Prod. No.: 001 RX (4.5GM/PACKET); 002 RX (6GM/PACKET); 003 RX (7.5GM/PACKET); 004 RX (9GM/PACKET)
PatentsExpirationChange
Pat. No. 12128021
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Dosaage regimen; Method of use
Use Code: U-4022: Treatment of a disorder in a human patient with a once-nightly GHB formulation by initiating treatment with a dose equivalent to 4.5 g of sodium oxybate and uptitrating in increments equivalent to 1.5 g of sodium oxybate
Jul 21, 2037New patent for this product
Pat. No. 12138239 DP*
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Pat. Sub. Date(s): All strengths: Nov 15, 2024
Claim Types: Formulation
Jul 21, 2037New patent for this product
Pat. No. 12144793 DP*
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Pat. Sub. Date(s): All strengths: Nov 22, 2024
Claim Types: Formulation
Jul 21, 2037New patent for this product

LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM LU 177 DOTATATE
NDA Applicant: AAA USA INC      NDA No.:
208700  Prod. No.: 001 RX (10mCi/ML)
PatentsExpirationChange
Pat. No. 12144873
Stable, concentrated radionuclide complex solutions
Pat. Sub. Date(s): 001: Nov 19, 2024
Claim Types: Method of use; ; Method of Use claimed by its inherent performace characteristics
Use Code: U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors
Jan 25, 2039 *PEDNew patent for this product
Pat. No. 12151003 DP*
Stable, Concentrated Radionuclide Complex Solutions
Pat. Sub. Date(s): 001: Nov 26, 2024
Claim Types: Formulation; Drug in a container; Method of use
Use Code: U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors
Jan 25, 2039 *PEDNew patent for this product
Pat. No. 12161732 DP*
Stable, Concentrated Radionuclide Complex Solutions
Pat. Sub. Date(s): 001: Dec 10, 2024
Claim Types: Process; Product-by-process; Method of use
Use Code: U-4036: Treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors
Jul 25, 2038New patent for this product

LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)
PatentsExpirationChange
Pat. No. 12144810 DP*
Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Pat. Sub. Date(s): All strengths: Dec 10, 2024
Claim Types: Formulation
Oct 7, 2029New patent for this product

MULTRYS (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT      NDA No.:
209376  Prod. No.: 003 RX (EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML))
PatentsExpirationChange
Pat. No. 12150956
Trace Element Compositions, Methods Of Making And Use
Pat. Sub. Date(s): 003: Dec 3, 2024
Claim Types: Method of use
Use Code: U-3900: Neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated
Jul 1, 2041New patent for this product
Pat. No. 12150957
Trace Element Compositions, Methods Of Making And Use
Pat. Sub. Date(s): 003: Dec 3, 2024
Claim Types: Method of administration
Use Code: U-3900: Neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated
Jul 1, 2041New patent for this product

NEXTSTELLIS (TABLET) (ORAL) DROSPIRENONE; ESTETROL
Drug Classes: progestin
NDA Applicant: MAYNE PHARMA      NDA No.:
214154  Prod. No.: 001 RX (3MG;14.2MG)
PatentsExpirationChange
Pat. No. 7732430 DP*
Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception
Pat. Sub. Date(s): 001: Apr 30, 2021
Claim Types: Method of use; Kit
Use Code: U-3152: Use by females of reproductive potential to prevent pregnancy
Mar 2, 2026New expiration date. Was previously Mar 2, 2025

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (INJECTABLE) (INTRAVENOUS) NICARDIPINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: dihydropyridine calcium channel blocker
NDA Applicant: CIPLA      NDA No.:
215592  Prod. No.: 001 RX (20MG/200ML (0.1MG/ML)); 002 RX (40MG/200ML (0.2MG/ML))
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy May 21, 2025New exclusivity for this product

OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS      NDA No.:
217677  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)
PatentsExpirationChange
Pat. No. 12138246
Treatments with nirogacestat
Pat. Sub. Date(s): All strengths: Nov 14, 2024
Claim Types:
Comments: Mehthod of use
Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors
May 19, 2043New patent for this product

ONGENTYS (CAPSULE) (ORAL) OPICAPONE
Drug Classes: catechol-O-methyltransferase (COMT) inhibitor
NDA Applicant: AMNEAL      NDA No.:
212489  Prod. No.: 001 RX (25MG); 002 RX (50MG)
PatentsExpirationChange
Pat. No. 12129247
Administration regime for nitrocatechols
Pat. Sub. Date(s): All strengths: Nov 26, 2024
Claim Types: Method of use; Dosaage regimen
Use Code: U-4038: Adjunctive treatment to levodopa/carbidopa in patients with parkinson's disease experiencing off episodes by administering without food
Jan 11, 2032New patent for this product

OPIPZA (FILM) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: XIAMEN LP PHARM CO      NDA No.:
216655  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG)
PatentsExpirationChange
Pat. No. 11331315 DP*
Aripiprazole oral soluble film
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Formulation
Nov 3, 2040New patent for this product
Pat. No. 11701352 DP*
Process for preparing aripiprazole oral soluble film
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Process
Dec 15, 2041New patent for this product

ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA      NDA No.:
214621  Prod. No.: 001 RX (120MG)
PatentsExpirationChange
Pat. No. 12144809
Treatment of prostate cancer
Pat. Sub. Date(s): 001: Nov 21, 2024
Claim Types: Method of use; Dosaage regimen
Use Code: U-4035: Treatment of adult patients with advanced prostate cancer, modified by dose-separating administrations of relugolix and a P-GP inhibitor, when co-administration of relugolix and the P-GP inhibitor is unavoidable
Sep 29, 2037New patent for this product

ORLADEYO (CAPSULE) (ORAL) BEROTRALSTAT HYDROCHLORIDE
Drug Classes: plasma kallikrein inhibitor
NDA Applicant: BIOCRYST      NDA No.:
214094  Prod. No.: 001 RX (EQ 110MG BASE); 002 RX (EQ 150MG BASE)
PatentsExpirationChange
Pat. No. 12116346 DS*
Human plasma kallikrein inhibitors
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Compound; New polymorph, salt or hydrate
Mar 9, 2035New patent for this product

ORLYNVAH (TABLET) (ORAL) PROBENECID; SULOPENEM ETZADROXIL
NDA Applicant: ITERUM THERAP      NDA No.:
213972  Prod. No.: 001 RX (500MG;500MG)
PatentsExpirationChange
Pat. No. 7795243 DS* DP*
Penem prodrugs
Pat. Sub. Date(s): 001: Nov 12, 2024
Claim Types: Compound; Composition; Method of use
Use Code: U-4026: Use in treating uncomplicated urinary tract infections caused by escherichia coli, klebsiella pneumoniae, or proteus mirabilis
Jun 3, 2029New patent for this product
Pat. No. 11478428 DP*
Combinations of beta-lactam compounds and probenecid and uses thereof
Pat. Sub. Date(s): 001: Nov 12, 2024
Claim Types: Formulation; Process; Method of use
Use Code: U-4026: Use in treating uncomplicated urinary tract infections caused by escherichia coli, klebsiella pneumoniae, or proteus mirabilis
Dec 23, 2039New patent for this product
Pat. No. 11554112
Combinations of β-lactam compounds and probenecid and uses thereof
Pat. Sub. Date(s): 001: Nov 12, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-4026: Use in treating uncomplicated urinary tract infections caused by escherichia coli, klebsiella pneumoniae, or proteus mirabilis
Apr 1, 2039New patent for this product
Pat. No. 12109197
Combinations of β-lactam compounds and probenecid and uses thereof
Pat. Sub. Date(s): 001: Nov 12, 2024
Claim Types: Method of use
Use Code: U-4026: Use in treating uncomplicated urinary tract infections caused by escherichia coli, klebsiella pneumoniae, or proteus mirabilis
Apr 1, 2039New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Oct 25, 2034 GAINNew exclusivity for this product

PIFELTRO (TABLET) (ORAL) DORAVIRINE
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: MSD MERCK CO      NDA No.:
210806  Prod. No.: 001 RX (100MG)
PatentsExpirationChange
Pat. No. 8486975 DS* DP*
Non-nucleoside reverse transcriptase inhibitors
Pat. Sub. Date(s): 001: Sep 17, 2018
Claim Types: Compound; Composition; Method of use
Use Code: U-2394: For use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history
Use Code: U-2630: For use in combination with other antiretroviral agents for the treatment of HIV-1 as a replacement therapy in virologically suppressed adults with no history of treatment failure and no known substitutions associated with resistance to doravirine
Use Code: U-3308: For use in combination with other antiretroviral agents to treat HIV-1 infection in pediatric patients weighing at least 35kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen if virologically suppressed
Aug 30, 2032New expiration date. Was previously Oct 7, 2031

PREVDUO (SOLUTION) (INTRAVENOUS) GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Drug Classes: anticholinergic == antimuscarinic agent == cholinesterase inhibitor
NDA Applicant: AZURITY      NDA No.:
216903  Prod. No.: 001 RX (0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML))
PatentsExpirationChange
Pat. No. 12151020 DP*
Ready-to-use Injectable Pharmaceutical Compositions Comprising Neostigmine And Glycopyrrolate
Pat. Sub. Date(s): 001: Nov 27, 2024
Claim Types: Formulation
Oct 25, 2038New patent for this product

QBRELIS (SOLUTION) (ORAL) LISINOPRIL
Drug Classes: angiotensin converting enzyme (ACE) inhibitor
NDA Applicant: AZURITY      NDA No.:
208401  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationChange
Pat. No. 12128083 DP*
Lisinopril formulations
Pat. Sub. Date(s): 001: Nov 12, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Nov 6, 2035New patent for this product

QELBREE (CAPSULE, EXTENDED RELEASE) (ORAL) VILOXAZINE HYDROCHLORIDE
Drug Classes: selective norepeinephrine reuptake inhibitor
NDA Applicant: SUPERNUS PHARMS      NDA No.:
211964  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 12121523
Method of treatment of attention deficit/hyperactivity disorder (ADHD)
Pat. Sub. Date(s): All strengths: Nov 21, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-727: For the treatment of attention deficit hyperactivity disorder (ADHD)
Sep 4, 2029New patent for this product

QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
209091  Prod. No.: 001 RX (10MG;EQ 5MG BASE)
PatentsExpirationChange
Pat. No. 6515117 DS* DP*
C-aryl glucoside SGLT2 inhibitors and method
Pat. Sub. Date(s): 001: Mar 22, 2017
Claim Types: Compound; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Apr 4, 2026 *PEDNew expiration date. Was previously Oct 4, 2025
Pat. No. 7919598 DS*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 001: Mar 22, 2017
Claim Types: New polymorph, salt or hydrate; Process
Jun 16, 2030 *PEDNew expiration date. Was previously Dec 16, 2029
Pat. No. 8221786 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 001: Mar 22, 2017
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8361972
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 001: Mar 22, 2017
Claim Types: Method of use
Use Code: U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
Use Code: U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8501698 DP*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 001: Mar 22, 2017
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Use Code: U-1976: Method for treating Type 2 diabetes mellitus (T2DM) in patients who have inadequate control with dapagliflozin
Use Code: U-1977: Method for treating Type 2 diabetes mellitus (T2DM) in patients who are already treated with dapagliflozin and saxagliptin
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Dec 20, 2027 *PEDNew expiration date. Was previously Jun 20, 2027
Pat. No. 8716251 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 001: Mar 22, 2017
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028

QTERN (TABLET) (ORAL) DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 209091  Prod. No.: 002 RX (5MG;EQ 5MG BASE)
PatentsExpirationChange
Pat. No. 6515117 DS* DP*
C-aryl glucoside SGLT2 inhibitors and method
Pat. Sub. Date(s): 002: May 24, 2019
Claim Types: Compound; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Apr 4, 2026 *PEDNew expiration date. Was previously Oct 4, 2025
Pat. No. 7919598 DS*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 002: May 24, 2019
Claim Types: New polymorph, salt or hydrate; Process
Jun 16, 2030 *PEDNew expiration date. Was previously Dec 16, 2029
Pat. No. 8221786 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 002: May 24, 2019
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8361972
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 002: May 24, 2019
Claim Types: Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8501698 DP*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 002: May 24, 2019
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Dec 20, 2027 *PEDNew expiration date. Was previously Jun 20, 2027
Pat. No. 8716251 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 002: May 24, 2019
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028

QTERNMET XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB      NDA No.:
210874  Prod. No.: 001 DISC (2.5MG;1GM;EQ 2.5MG BASE); 002 DISC (5MG;1GM;EQ 2.5MG BASE); 003 DISC (5MG;1GM;EQ 5MG BASE); 004 DISC (10MG;1GM;EQ 5MG BASE)
PatentsExpirationChange
Pat. No. 6515117 DS* DP*
C-aryl glucoside SGLT2 inhibitors and method
Pat. Sub. Date(s): All strengths: May 24, 2019
Claim Types: Compound; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Apr 4, 2026 *PEDNew expiration date. Was previously Oct 4, 2025
Pat. No. 7919598 DS*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): All strengths: May 24, 2019
Claim Types: New polymorph, salt or hydrate; Process
Jun 16, 2030 *PEDNew expiration date. Was previously Dec 16, 2029
Pat. No. 8501698 DP*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): All strengths: May 24, 2019
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Dec 20, 2027 *PEDNew expiration date. Was previously Jun 20, 2027
Pat. No. 8716251 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): All strengths: May 24, 2019
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 9616028 DP*
Bilayer tablet formulations
Pat. Sub. Date(s): All strengths: May 24, 2019
Claim Types: Formulation
May 12, 2031 *PEDNew expiration date. Was previously Nov 12, 2030

RELEXXII (TABLET, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [Has competitive generic]
Drug Classes: central nervous system stimulant
NDA Applicant: OSMOTICA PHARM US      NDA No.:
216117  Prod. No.: 001 RX (18MG); 002 RX (27MG); 003 RX (36MG); 004 RX (45MG); 005 RX (54MG); 006 RX (63MG); 007 RX (72MG)
PatentsExpirationChange
Pat. No. 9707217 DP*
Dose-dumping resistant controlled release dosage form
Pat. Sub. Date(s): All strengths: Nov 18, 2024
Claim Types: Device
Feb 3, 2037New patent for this product
Pat. No. 9827234
Dose-dumping resistant controlled release dosage form
Pat. Sub. Date(s): All strengths: Nov 18, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-4032: Treatment of attention deficit hyperactivity disorder (ADHD)
Feb 3, 2037New patent for this product
Pat. No. 9855258 DP*
Dose-dumping resistant controlled release dosage form
Pat. Sub. Date(s): All strengths: Nov 18, 2024
Claim Types: Device; Method of use
Use Code: U-4032: Treatment of attention deficit hyperactivity disorder (ADHD)
Feb 3, 2037New patent for this product
Pat. No. 10265308 DP*
Dose-dumping resistant controlled release dosage form
Pat. Sub. Date(s): All strengths: Nov 18, 2024
Claim Types: Formulation claimed by its inherent performace characteristics; Method of use
Use Code: U-4032: Treatment of attention deficit hyperactivity disorder (ADHD)
Feb 3, 2037New patent for this product
Pat. No. 10695336
Dose-dumping resistant controlled release dosage form
Pat. Sub. Date(s): All strengths: Nov 18, 2024
Claim Types: Method of Use claimed by its inherent performace characteristics
Use Code: U-4032: Treatment of attention deficit hyperactivity disorder (ADHD)
Feb 3, 2037New patent for this product

RETEVMO (CAPSULE) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.:
213246  Prod. No.: 001 RX (40MG); 002 RX (80MG)
PatentsExpirationChange
Pat. No. 12138250
Formulations of 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile
Pat. Sub. Date(s): All strengths: Dec 5, 2024
Claim Types: Method of use
Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Oct 10, 2038New patent for this product

RETEVMO (TABLET) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.: 218160  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (120MG); 004 RX (160MG)
PatentsExpirationChange
Pat. No. 12138250
Formulations of 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile
Pat. Sub. Date(s): All strengths: Dec 5, 2024
Claim Types: Method of use
Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory
Oct 10, 2038New patent for this product

REVUFORJ (TABLET) (ORAL) REVUMENIB CITRATE
NDA Applicant: SYNDAX      NDA No.:
218944  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 110MG BASE); 003 RX (EQ 160MG BASE)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Nov 15, 2029New product in Orange Book

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 001 RX (15MG)
PatentsExpirationChange
Pat. No. 12110297 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
Pat. Sub. Date(s): 001: Nov 5, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Oct 17, 2036New patent for this product
Pat. No. 12110298 DS* 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
Pat. Sub. Date(s): 001: Nov 5, 2024
Claim Types: Compound; Process; New polymorph, salt or hydrate
Oct 17, 2036New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 002 RX (30MG)
PatentsExpirationChange
Pat. No. 12110298 DS* 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
Pat. Sub. Date(s): 002: Nov 5, 2024
Claim Types: Compound; Process; New polymorph, salt or hydrate
Oct 17, 2036New patent for this product
Pat. No. 12116373 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
Pat. Sub. Date(s): 002: Nov 5, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Oct 17, 2036New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 003 RX (45MG)
PatentsExpirationChange
Pat. No. 12110298 DS* 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
Pat. Sub. Date(s): 003: Nov 5, 2024
Claim Types: Compound; Process; New polymorph, salt or hydrate
Oct 17, 2036New patent for this product
Pat. No. 12134621 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
Pat. Sub. Date(s): 003: Dec 4, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Oct 17, 2036New patent for this product

SCEMBLIX (TABLET) (ORAL) ASCIMINIB HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.:
215358  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-953: Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronicmyeloid leukemia (PH+ CML) in chronic phase (CP)Oct 29, 2027New exclusivity for this product
Exclusivity Code: I - New Indication: I-954: Treatment of adult patients with previously treated Philadelphia chromosome-positive chronicmyeloid leukemia (PH+ CML) in chronic phase (CP)Oct 29, 2027New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-499: Treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronicmyeloid leukemia (PH+ CML) in chronic phase (CP), excluding patients with the t315i mutationOct 29, 2031New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-500: Treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia ((PH+ CML) in chronic phase (CP), excluding patients previously treated with two or more tyrosine kinase inhibitors (TKIS), and excluding patients with the T315I mutationOct 29, 2031New exclusivity for this product

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))
PatentsExpirationChange
Pat. No. 12150957
Trace Element Compositions, Methods Of Making And Use
Pat. Sub. Date(s): All strengths: Dec 3, 2024
Claim Types: Method of administration
Use Code: U-4039: Adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated
Jul 1, 2041New patent for this product

SOHONOS (CAPSULE) (ORAL) PALOVAROTENE
Drug Classes: retinoid
NDA Applicant: IPSEN      NDA No.:
215559  Prod. No.: 001 RX (1MG); 002 RX (1.5MG); 003 RX (2.5MG); 004 RX (5MG); 005 RX (10MG)
PatentsExpirationChange
Pat. No. 12138245
Methods for treating heterotopic ossification
Pat. Sub. Date(s): All strengths: Nov 15, 2024
Claim Types: Method of administration; Dosaage regimen; Method of use
Use Code: U-4031: Reduction of heterotopic ossification in patients with fibrodysplasis (myositis) ossificans progressiva
Jun 8, 2037New patent for this product

SYNJARDY (TABLET) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
206111  Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (12.5MG;500MG); 004 RX (12.5MG;1GM)
PatentsExpirationChange
Pat. No. 12115179
Pharmaceutical composition, methods for treating and uses thereof
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Method of use
Use Code: U-4023: Treatment of type 2 diabetes mellitus by administration of empagliflozin, linagliptin and metformin
Feb 11, 2030New patent for this product

SYNJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
208658  Prod. No.: 001 RX (5MG;1GM); 002 RX (10MG;1GM); 003 RX (12.5MG;1GM); 004 RX (25MG;1GM)
PatentsExpirationChange
Pat. No. 12115179
Pharmaceutical composition, methods for treating and uses thereof
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Method of use
Use Code: U-4023: Treatment of type 2 diabetes mellitus by administration of empagliflozin, linagliptin and metformin
Feb 11, 2030New patent for this product

TAGRISSO (TABLET) (ORAL) OSIMERTINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
208065  Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-952: Treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved testSep 25, 2027New exclusivity for this product

TPOXX (SOLUTION) (INTRAVENOUS) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES      NDA No.:
214518  Prod. No.: 001 RX (200MG/20ML (10MG/ML))
PatentsExpirationChange
Pat. No. 8530509 DP*
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Pat. Sub. Date(s): None
Claim Types: Composition
Jun 18, 2024This patent is no longer listed for this product
Pat. No. 8802714
Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
Jun 18, 2024This patent is no longer listed for this product

TRALEMENT (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))
PatentsExpirationChange
Pat. No. 12150956
Trace Element Compositions, Methods Of Making And Use
Pat. Sub. Date(s): All strengths: Dec 3, 2024
Claim Types: Method of use
Use Code: U-3899: Adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated
Jul 1, 2041New patent for this product
Pat. No. 12150957
Trace Element Compositions, Methods Of Making And Use
Pat. Sub. Date(s): All strengths: Dec 3, 2024
Claim Types: Method of administration
Use Code: U-3899: Adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated
Jul 1, 2041New patent for this product

TRIJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.:
212614  Prod. No.: 001 RX (5MG;2.5MG;1GM); 002 RX (10MG;5MG;1GM); 003 RX (12.5MG;2.5MG;1GM); 004 RX (25MG;5MG;1GM)
PatentsExpirationChange
Pat. No. 12115179
Pharmaceutical composition, methods for treating and uses thereof
Pat. Sub. Date(s): All strengths: Nov 12, 2024
Claim Types: Method of use
Use Code: U-4023: Treatment of type 2 diabetes mellitus by administration of empagliflozin, linagliptin and metformin
Feb 11, 2030New patent for this product

TRULANCE (TABLET) (ORAL) PLECANATIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: SALIX      NDA No.:
208745  Prod. No.: 001 RX (3MG)
PatentsExpirationChange
Pat. No. 12146003 DP*
Ultra-pure agonists of guanylate cyclase C, method of making and using same
Pat. Sub. Date(s): 001: Nov 25, 2024
Claim Types: Formulation
Jun 5, 2034New patent for this product

TWYNEO (CREAM) (TOPICAL) BENZOYL PEROXIDE; TRETINOIN
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.:
214902  Prod. No.: 001 RX (3%;0.1%)
PatentsExpirationChange
Pat. No. 12133919 DP*
Stabilized microcapsules, method of their preparation and uses thereof
Pat. Sub. Date(s): 001: Dec 3, 2024
Claim Types: Formulation; Product-by-process; Method of use
Use Code: U-3987: Topical treatment of acne
May 23, 2041New patent for this product

TYVASO DPI (POWDER) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
214324  Prod. No.: 005 RX (0.08MG/INH)
PatentsExpirationChange
Pat. No. 9593066 DS*
Process to prepare treprostinil, the active ingredient in remodulin.RTM.
Pat. Sub. Date(s): 005: Nov 18, 2024
Claim Types: Composition; New polymorph, salt or hydrate
Dec 15, 2028New patent for this product
Pat. No. 10130685 DP*
Diketopiperazine salts for drug delivery and related methods
Pat. Sub. Date(s): 005: Nov 18, 2024
Claim Types: Formulation
Aug 23, 2025New patent for this product
Pat. No. 10421729 DP*
Microcrystalline diketopiperazine compositions and methods
Pat. Sub. Date(s): 005: Nov 18, 2024
Claim Types: Product-by-process; Process
Apr 1, 2035New patent for this product
Pat. No. 10772883 DP*
Diketopiperazine microparticles with defined specific surface areas
Pat. Sub. Date(s): 005: Nov 18, 2024
Claim Types: Composition
Jun 11, 2030New patent for this product
Pat. No. 11723887 DS*
Process to prepare treprostinil, the active ingredient in Remodulin®
Pat. Sub. Date(s): 005: Nov 18, 2024
Claim Types: Product-by-process; Process
Dec 15, 2028New patent for this product
Pat. No. 11826327
Treatment for interstitial lung disease
Pat. Sub. Date(s): 005: Nov 18, 2024
Claim Types: Method of use
Use Code: U-3749: Method of treating pulmonary hypertension associated with interstitial lung disease by administering treprostinil or a salt thereof by inhalation using a device
Feb 3, 2042New patent for this product

UZEDY (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: TEVA      NDA No.:
213586  Prod. No.: 001 RX (50MG/0.14ML (50MG/0.14ML)); 002 RX (75MG/0.21ML (75MG/0.21ML)); 003 RX (100MG/0.28ML (100MG/0.28ML)); 004 RX (125MG/0.35ML (125MG/0.35ML)); 005 RX (150MG/0.42ML (150MG/0.42ML)); 006 RX (200MG/0.56ML (200MG/0.56ML)); 007 RX (250MG/0.7ML (250MG/0.7ML))
PatentsExpirationChange
Pat. No. 12128132 DP*
Drug delivery formulations
Pat. Sub. Date(s): All strengths: Nov 18, 2024
Claim Types: Method of use; Formulation
Use Code: U-543: Treatment of schizophrenia
Sep 11, 2040New patent for this product

VYALEV (SOLUTION) (SUBCUTANEOUS) FOSCARBIDOPA; FOSLEVODOPA
NDA Applicant: ABBVIE      NDA No.:
216962  Prod. No.: 001 RX (120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML))
PatentsExpirationChange
Pat. No. 9446059 DS* DP*
Carbidopa and L-dopa prodrugs and methods of use
Pat. Sub. Date(s): 001: Nov 14, 2024
Claim Types: Formulation; Method of use; Kit; Compound
Use Code: U-4030: Treatment of motor fluctuations in adults with advanced parkinson's disease
Oct 21, 2035New patent for this product
Pat. No. 10174061 DP*
Carbidopa and L-dopa prodrugs and methods of use
Pat. Sub. Date(s): 001: Nov 14, 2024
Claim Types: Formulation; Method of use; Kit
Use Code: U-4030: Treatment of motor fluctuations in adults with advanced parkinson's disease
Oct 21, 2035New patent for this product
Pat. No. 10730895 DS*
Carbidopa prodrug
Pat. Sub. Date(s): 001: Nov 14, 2024
Claim Types: Compound
Oct 21, 2035New patent for this product

WINLEVI (CREAM) (TOPICAL) CLASCOTERONE
Drug Classes: androgen receptor inhibitor
NDA Applicant: SUN PHARM      NDA No.:
213433  Prod. No.: 001 RX (1%)
PatentsExpirationChange
Pat. No. 8143240
17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents
Pat. Sub. Date(s): 001: Sep 4, 2020
Claim Types: Method of use
Use Code: U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Jan 12, 2026New expiration date. Was previously Jan 12, 2025

XYWAV (SOLUTION) (ORAL) CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ      NDA No.:
212690  Prod. No.: 001 RX (0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML)
PatentsExpirationChange
Pat. No. 12139233

Pat. Sub. Date(s): 001: Dec 11, 2024
Claim Types:
Use Code: U-4044: Treatment of idiopathic hypersomnia with a mixture of sodium, potassium, magnesium, and calcium salts of GHB
Feb 22, 2041New patent for this product

ZILXI (AEROSOL, FOAM) (TOPICAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: JOURNEY      NDA No.:
213690  Prod. No.: 001 RX (EQ 1.5% BASE)
PatentsExpirationChange
Pat. No. 12138311
Topical tetracycline compositions
Pat. Sub. Date(s): 001: Dec 11, 2024
Claim Types: Method of use; Formulation
Use Code: U-1631: Treatment of inflammatory lesions of rosacea.
Oct 1, 2030New patent for this product

ZINC CHLORIDE (INJECTABLE) (INJECTION) ZINC CHLORIDE [GENERIC AP]
NDA Applicant: SOMERSET      NDA No.:
216152  Prod. No.: 001 RX (EQ 1MG ZINC/ML)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Apr 14, 2025New exclusivity for this product

ZTALMY (SUSPENSION) (ORAL) GANAXOLONE
Drug Classes: neuroactive steroid gamma-aminobutyric acid (GABA) A receptor
NDA Applicant: MARINUS      NDA No.:
215904  Prod. No.: 001 RX (50MG/ML)
PatentsExpirationChange
Pat. No. 12144801
Methods and compositions for treatment of epileptic disorders
Pat. Sub. Date(s): 001: Nov 21, 2024
Claim Types: Method of use; Dosaage regimen; Method of Use claimed by its inherent performace characteristics
Use Code: U-4034: Treatment of seizures associated with cyclin-dependent kinase-like-5 (CDLK5) deficiency disorder (CDD) in patients 2 years of age and older
Aug 10, 2037New patent for this product


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
Last edited: 18 December 2024
© 2001-2024 Bruce A. Pokras, All rights reserved worldwide