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Last Updated: March 28, 2024

COMTAN Drug Patent Profile


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When do Comtan patents expire, and what generic alternatives are available?

Comtan is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in COMTAN is entacapone. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Comtan

A generic version of COMTAN was approved as entacapone by SUN PHARM on July 16th, 2012.

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Drug patent expirations by year for COMTAN
Drug Prices for COMTAN

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Recent Clinical Trials for COMTAN

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SponsorPhase
Daniel ClaassenPhase 1
Xiangya Hospital of Central South UniversityEarly Phase 1
National Institute of Biological Sciences, BeijingPhase 1/Phase 2

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Pharmacology for COMTAN
Anatomical Therapeutic Chemical (ATC) Classes for COMTAN
Paragraph IV (Patent) Challenges for COMTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COMTAN Tablets entacapone 200 mg 020796 1 2007-04-11

US Patents and Regulatory Information for COMTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999 AB RX Yes Yes ⤷  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 COMTAN

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 COMTAN

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

International Patents for COMTAN

See the table below for patents covering COMTAN around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 0015196 ⤷  Try a Trial
Yugoslavia 48020 ⤷  Try a Trial
Poland 154006 ⤷  Try a Trial
Denmark 1112065 ⤷  Try a Trial
Eurasian Patent Organization 003282 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭНТАКАПОН ИЛИ НИТЕКАПОН, А ТАКЖЕ ПОПЕРЕЧНО-СШИТОЕ ПРОИЗВОДНОЕ ЦЕЛЛЮЛОЗЫ (PHARMACEUTICAL COMPOSITION COMPRISING ENTACAPONE OR NITECAPONE AS WELL AS A CROSS-LINKED CELLULOSE DERIVATIVE) ⤷  Try a Trial
Greece 3017526 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COMTAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 C00426468/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
0426468 CA 2004 00007 Denmark ⤷  Try a Trial
0426468 0490007-2 Sweden ⤷  Try a Trial PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
0426468 91071 Luxembourg ⤷  Try a Trial 91071, EXPIRES: 20151101
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.