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 | 9,872,854 | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | 11,236,091 | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | 10,092,541 | ⤷ 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 | 205437-002 | Mar 21, 2014 | 9,724,330 | ⤷ Try a Trial |
Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | 6,011,068 | ⤷ 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 |
---|---|---|
Japan | 2015007089 | ⤷ Try a Trial |
Spain | 2635361 | ⤷ Try a Trial |
Slovenia | 3630761 | ⤷ 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 | 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 | 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 |
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 |