Amgen Company Profile
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What is the competitive landscape for AMGEN, and what generic alternatives to AMGEN drugs are available?
AMGEN has five approved drugs.
There are seventeen US patents protecting AMGEN drugs.
There are three hundred and twenty-eight patent family members on AMGEN drugs in fifty-two countries and nineteen supplementary protection certificates in sixteen countries.
Summary for Amgen
International Patents: | 328 |
US Patents: | 17 |
Tradenames: | 4 |
Ingredients: | 5 |
NDAs: | 5 |
Patent Litigation for Amgen: | See patent lawsuits for Amgen |
PTAB Cases with Amgen as petitioner: | See PTAB cases with Amgen as petitioner |
PTAB Cases with Amgen as patent owner: | See PTAB cases with Amgen as patent owner |
Drugs and US Patents for Amgen
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,361,649*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,361,650*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-001 | May 28, 2021 | RX | Yes | No | 10,519,146 | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | AB | RX | Yes | No | 9,375,405 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>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 Amgen
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 7,208,516 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 7,893,101 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 7,659,302 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 9,018,243 | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AMGEN drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Tablets | 10 mg, 20 mg and30 mg | ➤ Subscribe | 2018-03-22 |
➤ Subscribe | Tablets | 30 mg, 60 mg and 90mg | ➤ Subscribe | 2008-03-10 |
International Patents for Amgen Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Malaysia | 158128 | ⤷ Sign Up |
Montenegro | 01408 | ⤷ Sign Up |
Portugal | 1707562 | ⤷ Sign Up |
Morocco | 28131 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amgen Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2962690 | C20190029 00295 | Estonia | ⤷ Sign Up | PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015 |
2962690 | C 2019 032 | Romania | ⤷ Sign Up | PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
2962690 | 300994 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
2962690 | 1990037-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |