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Last Updated: March 28, 2024

Entacapone - Generic Drug Details


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

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

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

Drug Prices for entacapone

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Recent Clinical Trials for entacapone

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

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Pharmacology for entacapone
Paragraph IV (Patent) Challenges for ENTACAPONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COMTAN Tablets entacapone 200 mg 020796 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic ENTACAPONE entacapone TABLET;ORAL 212601-001 Jan 4, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd ENTACAPONE entacapone TABLET;ORAL 205792-001 Aug 31, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd ENTACAPONE entacapone TABLET;ORAL 207210-001 Jun 5, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sunshine ENTACAPONE entacapone TABLET;ORAL 206669-001 Oct 3, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm ENTACAPONE entacapone TABLET;ORAL 090690-001 Jul 16, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd ENTACAPONE entacapone TABLET;ORAL 203437-001 Jun 19, 2015 AB RX No No ⤷  Try a Trial ⤷  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 entacapone

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

EU/EMA Drug Approvals for entacapone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Orion Corporation Entacapone Orion entacapone EMEA/H/C/002440
Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Authorised no no no 2011-08-18
Orion Corporation Comtess entacapone EMEA/H/C/000170
Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Authorised no no no 1998-09-16
Orion Corporation Comtan entacapone EMEA/H/C/000171
Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Authorised no no no 1998-09-22
Teva Pharma B.V. Entacapone Teva entacapone EMEA/H/C/002075
Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Authorised yes no no 2011-02-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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