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 | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,867,996*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | 7,427,638*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | AB | RX | Yes | Yes | 9,872,854*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen Inc | CORLANOR | ivabradine hydrochloride | TABLET;ORAL | 206143-001 | Apr 15, 2015 | AB | RX | Yes | No | 7,361,650*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ 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 |
| >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
Supplementary Protection Certificates for Amgen Inc Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2962690 | 2019/037 | Ireland | ⤷ Sign Up | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115 |
| 2962690 | C201930044 | Spain | ⤷ Sign Up | 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 | 37/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116 |
| 2962690 | 1990037-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116 |
| 2962690 | LUC00125 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116 |
| 2962690 | 122019000070 | Germany | ⤷ Sign Up | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
