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Last Updated: September 21, 2021

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Apremilast - Generic Drug Details

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What are the generic sources for apremilast and what is the scope of patent protection?

Apremilast is the generic ingredient in two branded drugs marketed by Amneal, Unichem, and Amgen Inc, and is included in three NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Apremilast has ninety-one patent family members in twenty-four countries.

There are twenty-eight drug master file entries for apremilast. Four suppliers are listed for this compound. There are six tentative approvals for this compound.

Recent Clinical Trials for apremilast

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AbbViePhase 3
AmgenPhase 3
Boehringer IngelheimPhase 1

See all apremilast clinical trials

Generic filers with tentative approvals for APREMILAST
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free30MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free20MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for apremilast
Paragraph IV (Patent) Challenges for APREMILAST
Tradename Dosage Ingredient NDA Submissiondate
OTEZLA TABLET;ORAL apremilast 205437 2018-03-22

US Patents and Regulatory Information for apremilast

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 apremilast

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014 ⤷  Try it Free ⤷  Try it Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014 ⤷  Try it Free ⤷  Try it Free
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for apremilast

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2962690 CA 2019 00033 Denmark ⤷  Try it Free PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116
2962690 C02962690/01 Switzerland ⤷  Try it Free PRODUCT NAME: APREMILAST; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65346 21.07.2015
2962690 C20190029 00295 Estonia ⤷  Try it Free PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015
2962690 C201930044 Spain ⤷  Try it Free 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 2019/037 Ireland ⤷  Try it Free PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Medtronic
Harvard Business School
Johnson and Johnson
Merck

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