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Last Updated: December 6, 2022

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 Inc, Accord Hlthcare, Alembic Pharms Ltd, 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, Mayne Pharma, Rubicon, SCS, Watson Labs, Avion Pharms, and Organon, and is included in thirty-two NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; levodopa has forty-five patent family members in fifteen countries.

Twenty-six 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
VistaGen Therapeutics, Inc.Phase 2
University of MinnesotaEarly Phase 1
University of RochesterPhase 2

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
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rising CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 078893-003 Sep 18, 2008 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Impax Labs CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 090631-003 Jun 8, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ucb Inc PARCOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 076699-003 Aug 27, 2004 DISCN No No 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 carbidopa; levodopa

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Organon Llc SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-001 May 30, 1991 See Plans and Pricing See Plans and Pricing
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 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 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
Israel 164856 COMBINATION IMMEDIATE RELEASE CONTROLLED RELEASE LEVODOPA/CARBIDOPA DOSAGE FORMS See Plans and Pricing
Spain 2606463 See Plans and Pricing
Japan 6033373 See Plans and Pricing
Japan 2005528430 See Plans and Pricing
World Intellectual Property Organization (WIPO) 03101432 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Mallinckrodt
McKinsey
Merck
Dow

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.