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 | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | 10,092,541 | ⤷ 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 | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,361,650*PED | ⤷ Try a Trial | Y | ⤷ 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 | |
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 | ||
>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 | 205437-003 | Mar 21, 2014 | 9,724,330 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | 6,211,244 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-001 | Mar 8, 2004 | 6,313,146 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,031,003 | ⤷ Try a Trial |
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 9,724,330 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | 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 |
---|---|---|
Hong Kong | 1073426 | ⤷ Try a Trial |
Portugal | 2420490 | ⤷ Try a Trial |
Hungary | E044822 | ⤷ Try a Trial |
South Korea | 20050012722 | ⤷ Try a Trial |
Spain | 2905676 | ⤷ Try a Trial |
Norway | 335739 | ⤷ 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 | C 2019 032 | Romania | ⤷ Try a Trial | 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 | C02962690/01 | Switzerland | ⤷ Try a Trial | VERTRETERLOESCHUNG |
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 | SPC/GB19/045 | United Kingdom | ⤷ Try a Trial | 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 | C201930044 | Spain | ⤷ Try a Trial | PRODUCT NAME: APREMILAST O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
1203761 | 05C0029 | France | ⤷ Try a Trial | PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |