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Last Updated: August 11, 2022

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. Sixteen 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999 See Plans and Pricing See Plans and Pricing
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999 See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for COMTAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0426468 CA 2004 00007 Denmark See Plans and Pricing
0426468 C00426468/01 Switzerland See Plans and Pricing FORMER REPRESENTATIVE: BOHEST AG, CH
0426468 91071 Luxembourg See Plans and Pricing 91071, EXPIRES: 20151101
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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