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Last Updated: November 22, 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 019856-002 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 019856-001 May 30, 1991 ⤷  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
>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
Romania 62503 ⤷  Sign Up
U.S.S.R. 701530 METHOD OF PREPARING SUBSTITUTED L-ALPHAHYDRAZINO-BETA-PNENYLPROPIONIC ACIDS ⤷  Sign Up
Poland 96933 ⤷  Sign Up
Australia 597670 ⤷  Sign Up
Austria 332381 ⤷  Sign Up
Spain 413739 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.