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 eighteen patent family members on AMGEN drugs in fifty-two countries and nineteen supplementary protection certificates in sixteen countries.
Summary for Amgen
International Patents: | 318 |
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 | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | AB | RX | Yes | No | 7,829,595 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | 10,519,146 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | RX | Yes | Yes | 7,867,996 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-002 | Apr 15, 2015 | AB | RX | Yes | Yes | 7,879,842*PED | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | 7,893,101 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 7,893,101 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 7,659,302 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | 6,211,244 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 8,455,536 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | 6,011,068 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 9,724,330 | ⤷ Try a Trial |
>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 | 30 mg, 60 mg and 90mg | ➤ Subscribe | 2008-03-10 |
➤ Subscribe | Tablets | 10 mg, 20 mg and30 mg | ➤ Subscribe | 2018-03-22 |
International Patents for Amgen Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Cuba | 20060037 | ⤷ Try a Trial |
Mexico | 366328 | ⤷ Try a Trial |
Mexico | 2021011115 | ⤷ Try a Trial |
Portugal | 2962690 | ⤷ Try a Trial |
Austria | E407926 | ⤷ Try a Trial |
Japan | 5026077 | ⤷ Try a Trial |
Argentina | 111882 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amgen Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1203761 | C01203761/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004 |
2962690 | 1990037-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116 |
2962690 | CA 2019 00033 | Denmark | ⤷ Try a Trial | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
2962690 | C02962690/01 | Switzerland | ⤷ Try a Trial | VERTRETERLOESCHUNG |
1203761 | SPC/GB05/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CINACALCET OR A PHARMACEUTICALLY ACCEPTABLE SALT OR COMPLEX THEREOF; REGISTERED: UK EU/1/04/292/001 20041022; UK EU/1/04/292/002 20041022; UK EU/1/04/292/003 20041022; UK EU/1/04/292/004 20041022; UK EU/1/04/292/005 20041022; UK EU/1/04/292/006 20041022; UK EU/1/04/292/007 20041022; UK EU/1/04/292/008 20041022; UK EU/1/04/292/009 20041022; UK EU/1/04/292/010 20041022; UK EU/1/04/292/011 20041022; UK EU/1/04/292/012 20041022; UK EU/1/04/293/001 20041022; UK EU/1/04/293/002 20041022; UK EU/1/04/293/003 20041022; UK EU/1/04/293/004 20041022; UK EU/1/04/293/005 20041022; UK EU/1/04/293/006 20041022; UK EU/1/04/293/007 20041022; UK EU/1/04/293/008 20041022; UK EU/1/04/293/009 200410 |
2962690 | CR 2019 00033 | Denmark | ⤷ Try a Trial | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
2962690 | C20190029 00295 | Estonia | ⤷ Try a Trial | PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |