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Last Updated: March 19, 2024

Amgen Company Profile


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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 ⤷  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 205437-002 Mar 21, 2014 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes 7,879,842 ⤷  Try a Trial Y Y ⤷  Try a Trial
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964-001 Apr 22, 2019 RX Yes Yes 7,361,649 ⤷  Try a Trial Y Y ⤷  Try a Trial
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-001 May 28, 2021 RX Yes No 11,426,404 ⤷  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 205437-003 Mar 21, 2014 6,020,358 ⤷  Try a Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 7,659,302 ⤷  Try a Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 7,208,516 ⤷  Try a Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 8,455,536 ⤷  Try a Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 9,018,243 ⤷  Try a Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 6,011,068 ⤷  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

Supplementary Protection Certificates for Amgen Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 132019000000096 Italy ⤷  Try a Trial PRODUCT NAME: APREMILAST(OTEZLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/981, 20150116
2962690 37/2019 Austria ⤷  Try a Trial PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690 2019C/008 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
2962690 1990037-2 Sweden ⤷  Try a Trial PRODUCT NAME: APREMILAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/14/981 20150116
1203761 05C0029 France ⤷  Try a Trial PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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