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Merck
Harvard Business School
Johnson and Johnson
Mallinckrodt
Medtronic
Baxter

Last Updated: January 29, 2022

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CARBIDOPA; LEVODOPA - Generic Drug Details

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What are the generic drug sources for carbidopa; levodopa and what is the scope of freedom to operate?

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, Ranbaxy, Sun Pharm, Ucb Inc, Actavis Elizabeth, Ani Pharms, Apotex Inc, Mayne Pharma, SCS, Watson Labs, and Avion Pharms, and is included in thirty-one 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-six suppliers are listed for this compound.

Recent Clinical Trials for CARBIDOPA; LEVODOPA

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

SponsorPhase
VistaGen Therapeutics, Inc.Phase 2
BioVie Inc.Phase 1/Phase 2
National Institutes of Health (NIH)Phase 2

See all CARBIDOPA; LEVODOPA clinical trials

Pharmacology 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 073587-001 Jun 29, 1995 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 078690-001 Jul 31, 2009 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 078893-002 Sep 18, 2008 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Elizabeth CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 074260-001 Sep 3, 1993 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  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
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Organon SINEMET carbidopa; levodopa TABLET;ORAL 017555-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Organon SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-002 Dec 24, 1992 ⤷  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:

Moodys
Medtronic
AstraZeneca
Harvard Business School
Baxter
Johnson and Johnson

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