Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Patents | Expiration | Change |
---|---|---|
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, 2041 | New patent for this product |
AMELUZ (GEL) (TOPICAL) AMINOLEVULINIC ACID HYDROCHLORIDE
NDA Applicant: BIOFRONTERA NDA No.: 208081 Prod. No.: 001 RX (10%)
Exclusivity | Expiration | Change |
---|---|---|
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, 2027 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2035 | New 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, 2035 | New 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))
Patents | Expiration | Change |
---|---|---|
Pat. No. 12138264 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Dec 5, 2024 Claim Types: Formulation; Dosaage regimen; Method of use | Sep 15, 2031 | New patent for this product |
ARAZLO (LOTION) (TOPICAL) TAZAROTENE
Drug Classes: retinoid
NDA Applicant: BAUSCH NDA No.: 211882 Prod. No.: 001 RX (0.045%)
Patents | Expiration | Change |
---|---|---|
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, 2038 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2043 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2039 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2036 | New 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, 2036 | New 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, 2036 | New 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))
Patents | Expiration | Change |
---|---|---|
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 *PED | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2031 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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%)
Patents | Expiration | Change |
---|---|---|
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, 2040 | New 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, 2040 | New 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, 2040 | New 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)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12133878 DP* Pharmaceutical compositions having a selected release duration Pat. Sub. Date(s): 001: Nov 12, 2024 Claim Types: Formulation | Dec 18, 2037 | New 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)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Apr 9, 2025 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2035 | New 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, 2035 | New 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)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | May 18, 2025 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2034 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2040 | New 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, 2040 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2039 | New 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, 2039 | New 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, 2039 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2041 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2041 | New 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, 2041 | New 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, 2044 | New 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%)
Patents | Expiration | Change |
---|---|---|
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, 2033 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2036 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2030 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2043 | New 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)
Patents | Expiration | Change |
---|---|---|
Pat. No. 11957681 DP* Liquid dosage forms of Imatinib Pat. Sub. Date(s): 001: Nov 27, 2024 Claim Types: Formulation | Apr 27, 2040 | New product in Orange Book |
IMVEXXY (INSERT) (VAGINAL) ESTRADIOL
Drug Classes: estrogen
NDA Applicant: MAYNE PHARMA NDA No.: 208564 Prod. No.: 001 RX (0.004MG)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | This 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)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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, 2032 | New 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))
Patents | Expiration | Change |
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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, 2028 | New 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, 2027 | New 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%)
Patents | Expiration | Change |
---|---|---|
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, 2033 | New patent for this product |
ITOVEBI (TABLET) (ORAL) INAVOLISIB
NDA Applicant: GENENTECH INC NDA No.: 219249 Prod. No.: 001 RX (3MG); 002 RX (9MG)
Patents | Expiration | Change |
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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, 2030 | New 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, 2030 | New 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, 2036 | New 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, 2036 | New 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, 2038 | New 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, 2036 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: NCE - New chemical entity | Oct 10, 2029 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2030 | New 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)
Patents | Expiration | Change |
---|---|---|
Pat. No. 11975096 DP* Liquid naloxone spray Pat. Sub. Date(s): 001: Dec 4, 2024 Claim Types: Formulation | Aug 26, 2034 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2037 | New 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, 2037 | New 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, 2037 | New 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)
Patents | Expiration | Change |
---|---|---|
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 *PED | New 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 *PED | New 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, 2038 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2029 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2041 | New 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, 2041 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2026 | New 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))
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | May 21, 2025 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2043 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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)
Patents | Expiration | Change |
---|---|---|
Pat. No. 11331315 DP* Aripiprazole oral soluble film Pat. Sub. Date(s): All strengths: Nov 12, 2024 Claim Types: Formulation | Nov 3, 2040 | New 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, 2041 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2037 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2035 | New patent for this product |
ORLYNVAH (TABLET) (ORAL) PROBENECID; SULOPENEM ETZADROXIL
NDA Applicant: ITERUM THERAP NDA No.: 213972 Prod. No.: 001 RX (500MG;500MG)
Patents | Expiration | Change |
---|---|---|
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, 2029 | New 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, 2039 | New 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, 2039 | New 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, 2039 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: NCE - New chemical entity | Oct 25, 2034 GAIN | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2032 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2038 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2035 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2029 | New 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)
Patents | Expiration | Change |
---|---|---|
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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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)
Patents | Expiration | Change |
---|---|---|
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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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)
Patents | Expiration | Change |
---|---|---|
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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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 *PED | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2037 | New 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, 2037 | New 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, 2037 | New 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, 2037 | New 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, 2037 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2038 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2038 | New 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)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NCE - New chemical entity | Nov 15, 2029 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2036 | New 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, 2036 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2036 | New 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, 2036 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2036 | New 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, 2036 | New 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)
Exclusivity | Expiration | Change |
---|---|---|
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, 2027 | New 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, 2027 | New 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 mutation | Oct 29, 2031 | New 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 mutation | Oct 29, 2031 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2041 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2037 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2030 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2030 | New 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)
Exclusivity | Expiration | Change |
---|---|---|
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 test | Sep 25, 2027 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2024 | This 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, 2024 | This 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))
Patents | Expiration | Change |
---|---|---|
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, 2041 | New 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, 2041 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2030 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2034 | New 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%)
Patents | Expiration | Change |
---|---|---|
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, 2041 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2028 | New 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, 2025 | New 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, 2035 | New 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, 2030 | New 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, 2028 | New 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, 2042 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2040 | New 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))
Patents | Expiration | Change |
---|---|---|
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, 2035 | New 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, 2035 | New patent for this product |
Pat. No. 10730895 DS* Carbidopa prodrug Pat. Sub. Date(s): 001: Nov 14, 2024 Claim Types: Compound | Oct 21, 2035 | New 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%)
Patents | Expiration | Change |
---|---|---|
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, 2026 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2041 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2030 | New 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)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Apr 14, 2025 | New 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)
Patents | Expiration | Change |
---|---|---|
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, 2037 | New patent for this product |