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-two patent family members on AMGEN drugs in fifty-two countries and nineteen supplementary protection certificates in sixteen countries.
Summary for Amgen
International Patents: | 322 |
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 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | 7,427,638 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | |
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-001 | May 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | |||||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | 7,427,638 | ⤷ Try a Trial | Y | Y | ⤷ 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 | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | 6,011,068 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,211,244 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 9,018,243 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 6,962,940 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | 6,211,244 | ⤷ 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 | 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 |
---|---|---|
Australia | 2021245150 | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 03080049 | ⤷ Try a Trial |
Slovenia | 1707562 | ⤷ Try a Trial |
Japan | 7095052 | ⤷ Try a Trial |
New Zealand | 545498 | ⤷ 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 |
---|---|---|---|---|
2962690 | C20190029 00295 | Estonia | ⤷ Try a Trial | PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015 |
2962690 | 132019000000096 | Italy | ⤷ Try a Trial | PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116 |
2962690 | 2019C/008 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
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 | 37/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |