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Last Updated: March 19, 2024

Carbidopa; levodopa - Generic Drug Details


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What are the generic sources for carbidopa; levodopa and what is the scope of patent protection?

Carbidopa; levodopa is the generic ingredient in eight branded drugs marketed by Impax Labs Inc, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Organon Llc, Ranbaxy, Rising, Sun Pharm, Ucb Inc, Actavis Elizabeth, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rubicon, SCS, Watson Labs, Zydus Pharms, Avion Pharms, and Organon, and is included in thirty-four NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; levodopa has thirty-two patent family members in thirteen countries.

Thirty-three suppliers are listed for this compound.

Summary for carbidopa; levodopa
Recent Clinical Trials for carbidopa; levodopa

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

SponsorPhase
Bronx VA Medical CenterPhase 1
VistaGen Therapeutics, Inc.Phase 2
University of MinnesotaEarly Phase 1

See all carbidopa; levodopa clinical trials

Pharmacology for carbidopa; levodopa
Anatomical Therapeutic Chemical (ATC) Classes for carbidopa; levodopa
Paragraph IV (Patent) Challenges for CARBIDOPA; LEVODOPA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RYTARY Extended-release Capsules carbidopa; levodopa 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg 203312 1 2015-06-24
RYTARY Extended-release Capsules carbidopa; levodopa 61.25 mg/245 mg 203312 1 2015-06-10

US Patents and Regulatory Information for carbidopa; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 202323-001 Feb 8, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 074260-001 Sep 3, 1993 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 216505-003 Sep 21, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073587-001 Jun 29, 1995 DISCN 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 carbidopa; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-001 May 30, 1991 ⤷  Try a Trial ⤷  Try a Trial
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for carbidopa; levodopa

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 carbidopa; levodopa

Country Patent Number Title Estimated Expiration
Japan 5783725 ⤷  Try a Trial
South Korea 20150133854 레보도파 방출 제어형 제제 및 이의 용도 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2019191353 ⤷  Try a Trial
Japan 6328205 ⤷  Try a Trial
>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.