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Last Updated: May 31, 2020

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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 CORLANOR ivabradine hydrochloride TABLET;ORAL 206143-002 Apr 15, 2015 RX Yes Yes 7,879,842*PED   Start Trial Y   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 RX Yes No 7,893,101   Start Trial Y Y   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 AB RX Yes No 9,375,405   Start Trial Y   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 RX Yes No 7,659,302   Start Trial   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 RX Yes Yes 9,872,854   Start Trial   Start 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 SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 6,313,146   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 6,211,244   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 6,011,068   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 6,031,003   Start Trial
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 6,020,358   Start 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 122019000070 Germany   Start Trial PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 20150115
2962690 37/2019 Austria   Start Trial PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116
2962690 LUC00125 Luxembourg   Start Trial PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/14/981 20150116
2962690 C201930044 Spain   Start 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   Start 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
Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Harvard Business School
Moodys

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