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 | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | AB | RX | Yes | No | 9,375,405 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | 7,427,638*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ 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 | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | 6,313,146 | ⤷ Sign Up |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 6,962,940 | ⤷ Sign Up |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,313,146 | ⤷ 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 | 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
Supplementary Protection Certificates for Amgen Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1203761 | 05C0029 | France | ⤷ Sign Up | PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022 |
| 2962690 | 1990037-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116 |
| 2962690 | CR 2019 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
