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 twenty-four US patents protecting AMGEN drugs. There is one tentative approval on AMGEN drugs.
There are three hundred patent family members on AMGEN drugs in fifty-two countries and nineteen supplementary protection certificates in sixteen countries.
Summary for Amgen
| International Patents: | 300 |
| US Patents: | 24 |
| 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 | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | 9,724,330 | See Plans and Pricing | See Plans and Pricing | |||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | 8,455,536 | See Plans and Pricing | See Plans and Pricing | |||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | 8,802,717 | See Plans and Pricing | See Plans and Pricing | |||
| Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | RX | Yes | Yes | 7,879,842 | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | 7,659,302 | See Plans and Pricing | See Plans and Pricing | |||
| >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 | 021688-001 | Mar 8, 2004 | 6,011,068 | See Plans and Pricing |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-002 | Mar 8, 2004 | 6,011,068 | See Plans and Pricing |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,313,146 | See Plans and Pricing |
| Amgen | SENSIPAR | cinacalcet hydrochloride | TABLET;ORAL | 021688-003 | Mar 8, 2004 | 6,011,068 | See Plans and Pricing |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 6,020,358 | See Plans and Pricing |
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 202193113 | See Plans and Pricing |
| Japan | 2021523216 | See Plans and Pricing |
| Costa Rica | 20210665 | See Plans and Pricing |
| South Africa | 200601764 | See Plans and Pricing |
| European Patent Office | 3395340 | See Plans and Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amgen Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2962690 | 132019000000096 | Italy | See Plans and Pricing | PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116 |
| 2962690 | 122019000070 | Germany | See Plans and Pricing | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115 |
| 1203761 | 05C0029 | France | See Plans and Pricing | PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022 |
| 2962690 | 37/2019 | Austria | See Plans and Pricing | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116 |
| 2962690 | 300994 | Netherlands | See Plans and Pricing | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
