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Last Updated: August 4, 2020

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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 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 Inc, Apotex Inc, Mayne Pharma, SCS, and Watson Labs, and is included in twenty-eight 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-seven patent family members in fourteen countries.

There are eighteen drug master file entries for carbidopa; levodopa. Twenty-two 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
Emory UniversityPhase 2
Vanderbilt University Medical CenterPhase 2
Columbia UniversityPhase 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 Inc CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 073587-001 Jun 29, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Mylan CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 075091-002 Apr 21, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, ORALLY DISINTEGRATING;ORAL 078893-003 Sep 18, 2008 AB RX No Yes   Start Trial   Start Trial   Start 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
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Merck Sharp Dohme SINEMET CR carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 019856-002 Dec 24, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
AstraZeneca
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Baxter
Johnson and Johnson

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