AMGEN INC Company Profile
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What is the competitive landscape for AMGEN INC, and when can generic versions of AMGEN INC drugs launch?
AMGEN INC has four approved drugs.
There are fifteen US patents protecting AMGEN INC drugs.
There are two hundred and seventy-five patent family members on AMGEN INC drugs in fifty-one countries and sixteen supplementary protection certificates in fifteen countries.
Summary for AMGEN INC
International Patents: | 275 |
US Patents: | 15 |
Tradenames: | 3 |
Ingredients: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 9 |
Patent Litigation for AMGEN INC: | See patent lawsuits for AMGEN INC |
PTAB Cases with AMGEN INC as petitioner: | See PTAB cases with AMGEN INC as petitioner |
PTAB Cases with AMGEN INC as patent owner: | See PTAB cases with AMGEN INC as patent owner |
Drugs and US Patents for AMGEN INC
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 | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | 7,427,638*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-002 | Apr 15, 2015 | AB | RX | Yes | Yes | 7,361,650*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-003 | Jun 26, 2024 | RX | Yes | No | 11,236,091 | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ||||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-002 | Apr 15, 2015 | AB | RX | Yes | Yes | 7,867,996*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-001 | May 28, 2021 | RX | Yes | No | 11,426,404 | ⤷ 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 INC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 7,893,101 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 9,724,330 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 9,018,243 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 8,802,717 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 6,962,940 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 6,020,358 | ⤷ Sign Up |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 8,455,536 | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AMGEN INC drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Tablets | 10 mg, 20 mg and30 mg | ➤ Subscribe | 2018-03-22 |
International Patents for AMGEN INC Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Uruguay | 38710 | ⤷ Sign Up |
European Patent Office | 1695965 | ⤷ Sign Up |
Malaysia | 158128 | ⤷ Sign Up |
South Korea | 101263786 | ⤷ Sign Up |
Morocco | 55959 | ⤷ Sign Up |
France | 2882553 | ⤷ Sign Up |
Austria | E396974 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMGEN INC Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2962690 | 365 14-2019 | Slovakia | ⤷ Sign Up | PRODUCT NAME: APREMILAST VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/981 20150116 |
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 | CR 2019 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
2962690 | SPC/GB19/045 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/14/981/001(NI) 20150116; UK EU/1/14/981/002(NI) 20150116; UK EU/1/14/981/003(NI) 20150116; UK PLGB 50412/0006 20150116; UK PLGB 50412/0007 20150116 |
2962690 | 300994 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
2962690 | C20190029 00295 | Estonia | ⤷ Sign Up | PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015 |
2962690 | 132019000000096 | Italy | ⤷ Sign Up | PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |