Amneal Company Profile
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What is the competitive landscape for AMNEAL, and when can generic versions of AMNEAL drugs launch?
AMNEAL has four hundred and three approved drugs.
There are twenty-three US patents protecting AMNEAL drugs. There are seven tentative approvals on AMNEAL drugs.
There are one hundred and fifty-eight patent family members on AMNEAL drugs in thirty-one countries and eight hundred and forty-five supplementary protection certificates in nineteen countries.
Summary for Amneal
International Patents: | 158 |
US Patents: | 23 |
Tradenames: | 305 |
Ingredients: | 295 |
NDAs: | 403 |
Patent Litigation for Amneal: | See patent lawsuits for Amneal |
PTAB Cases with Amneal as petitioner: | See PTAB cases with Amneal as petitioner |
Drugs and US Patents for Amneal
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal | ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 211293-003 | Feb 4, 2019 | AB1 | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
Amneal Pharms Co | ETODOLAC | etodolac | TABLET;ORAL | 208834-001 | Jun 7, 2018 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
Amneal Pharms Co | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208831-002 | Nov 21, 2017 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
Amneal Pharm | FLECAINIDE ACETATE | flecainide acetate | TABLET;ORAL | 075442-002 | Jul 31, 2001 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
Amneal Pharm | GUANFACINE HYDROCHLORIDE | guanfacine hydrochloride | TABLET;ORAL | 075109-002 | Nov 25, 1998 | AB | RX | No | Yes | ⤷ Subscribe | ⤷ Subscribe | ||||
Amneal Pharms | LACOSAMIDE | lacosamide | TABLET;ORAL | 204857-004 | Mar 17, 2022 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | |||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for Amneal
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | RE36247 | ⤷ Subscribe |
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 6,750,237*PED | ⤷ Subscribe |
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 7,220,767*PED | ⤷ Subscribe |
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | 7,220,767*PED | ⤷ Subscribe |
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 5,466,699*PED | ⤷ Subscribe |
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | 6,750,237*PED | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AMNEAL drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Nasal Spray | 2.5 mg/spray | ➤ Subscribe | 2016-06-09 |
➤ Subscribe | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
➤ Subscribe | Nasal Spray | 5 mg/spray | ➤ Subscribe | 2013-11-14 |
➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
International Patents for Amneal Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Cyprus | 1122580 | ⤷ Subscribe |
Japan | 2015500335 | ⤷ Subscribe |
Netherlands | 300848 | ⤷ Subscribe |
South Korea | 20080033243 | ⤷ Subscribe |
South Korea | 101370280 | ⤷ Subscribe |
Spain | 2912968 | ⤷ Subscribe |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amneal Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0984957 | 122012000017 | Germany | ⤷ Subscribe | PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812 |
1907382 | 300848 | Netherlands | ⤷ Subscribe | PRODUCT NAME: OPICAPON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1066 20160628 |
0720599 | 92544 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724 |
1907382 | 93327 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: OPICAPONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/15/1066 - ONGENTYS - OPICAPONE |
0219829 | SPC/GB06/034 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529 |
0123238 | SPC/GB95/004 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.