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Last Updated: September 21, 2021

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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 seven branded drugs marketed by Impax Labs Inc, Abbvie Inc, Accord Hlthcare, Alembic Pharms Ltd, Apotex, Impax Labs, Kv Pharm, Mylan, Sun Pharm Inds, Merck Sharp Dohme, Ranbaxy, Sun Pharm, Ucb Inc, Actavis Elizabeth, Ani Pharms, Apotex Inc, Mayne Pharma, Sciegen Pharms Inc, SCS, and Watson Labs, and is included in twenty-nine NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; levodopa has thirty-eight patent family members in fourteen countries.

There are eighteen drug master file entries for carbidopa; levodopa. Twenty-five suppliers are listed for this compound.

Recent Clinical Trials for carbidopa; levodopa

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

SponsorPhase
University of IbadanPhase 1/Phase 2
University of WashingtonPhase 4
Western University, CanadaN/A

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 NDA Submissiondate
RYTARY CAPSULE, EXTENDED RELEASE;ORAL carbidopa; levodopa 203312 2015-06-24
RYTARY CAPSULE, EXTENDED RELEASE;ORAL carbidopa; levodopa 203312 2015-06-10
SINEMET CR TABLET, EXTENDED RELEASE;ORAL carbidopa; levodopa 019856

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
Ani Pharms CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073587-002 Jun 29, 1995 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apotex CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 076212-002 Jun 16, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-002 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Ucb Inc PARCOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 076699-001 Aug 27, 2004 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apotex CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 076212-001 Jun 16, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-002 Dec 24, 1992 ⤷  Try it Free ⤷  Try it Free
Merck Sharp Dohme SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-001 May 30, 1991 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
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McKinsey
Merck
Dow

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