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Last Updated: November 2, 2024

SINEMET CR Drug Patent Profile


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Which patents cover Sinemet Cr, and what generic alternatives are available?

Sinemet Cr is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in SINEMET CR is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sinemet Cr

A generic version of SINEMET CR was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28th, 1992.

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Summary for SINEMET CR
Drug patent expirations by year for SINEMET CR
Recent Clinical Trials for SINEMET CR

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

SponsorPhase
University of California, Los AngelesPhase 1/Phase 2
Laboratorios Andromaco S.A.Phase 1
Northwestern Medical GroupPhase 2

See all SINEMET CR clinical trials

US Patents and Regulatory Information for SINEMET CR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-002 Dec 24, 1992 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-001 May 30, 1991 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 SINEMET CR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-001 May 30, 1991 ⤷  Sign Up ⤷  Sign Up
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-002 Dec 24, 1992 ⤷  Sign Up ⤷  Sign Up
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-001 May 30, 1991 ⤷  Sign Up ⤷  Sign Up
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-002 Dec 24, 1992 ⤷  Sign Up ⤷  Sign Up
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-001 May 30, 1991 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for SINEMET CR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amneal Pharma Europe Ltd Numient levodopa, carbidopa EMEA/H/C/002611
Symptomatic treatment of adult patients with Parkinson’s disease
Withdrawn no no no 2015-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SINEMET CR

See the table below for patents covering SINEMET CR around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0320051 CONTROLLED RELEASE COMBINATION OF CARBIDOPA/LEVODOPA ⤷  Sign Up
Poland 97087 ⤷  Sign Up
Hong Kong 56191 CONTROLLED RELEASE COMBINATION OF CARBIDOPA/LEVODOPA ⤷  Sign Up
Bulgaria 19136 ⤷  Sign Up
Canada 919690 PROCESS FOR PREPARING SUBSTITUTED PHENYLALKANOIC ACIDS ⤷  Sign Up
Czechoslovakia 178086 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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