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Last Updated: August 10, 2020

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ENTACAPONE - Generic Drug Details

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What are the generic sources for entacapone and what is the scope of freedom to operate?

Entacapone is the generic ingredient in two branded drugs marketed by Orion Pharma, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Sun Pharm, Sunshine Lake, and Wockhardt Ltd, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for entacapone. Sixteen suppliers are listed for this compound.

Drug Prices for ENTACAPONE

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Recent Clinical Trials for ENTACAPONE

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

SponsorPhase
Xiangya Hospital of Central South UniversityEarly Phase 1
Bial - Portela C S.A.Phase 4
LobSor Pharmaceuticals ABPhase 1

See all ENTACAPONE clinical trials

Pharmacology for ENTACAPONE
Paragraph IV (Patent) Challenges for ENTACAPONE
Tradename Dosage Ingredient NDA Submissiondate
COMTAN TABLET;ORAL entacapone 020796 2007-04-11

US Patents and Regulatory Information for ENTACAPONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc ENTACAPONE entacapone TABLET;ORAL 202394-001 May 13, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Sunshine Lake ENTACAPONE entacapone TABLET;ORAL 206669-001 Oct 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd ENTACAPONE entacapone TABLET;ORAL 205792-001 Aug 31, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ENTACAPONE entacapone TABLET;ORAL 203437-001 Jun 19, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Ltd ENTACAPONE entacapone TABLET;ORAL 078941-001 Aug 16, 2012 AB RX No No   Start Trial   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 ENTACAPONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Express Scripts
Dow
Boehringer Ingelheim
Merck

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