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Last Updated: November 22, 2024

CARBIDOPA - Generic Drug Details


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

Carbidopa is the generic ingredient in eighteen branded drugs marketed by Alvogen, Ani Pharms, Aurobindo Pharma, Beximco Pharms Usa, Edenbridge Pharms, Novel Labs Inc, Zydus Pharms, Aton, Norvium Bioscience, Rising, Sun Pharm, Wockhardt Ltd, Orion Pharma, Impax, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon, Sciegen Pharms Inc, Sun Pharm Inds, Organon Llc, Ranbaxy, Ucb Inc, Actavis Elizabeth, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, Avion Pharms, and Organon, and is included in fifty NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for carbidopa. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CARBIDOPA
Drug Prices for CARBIDOPA

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Recent Clinical Trials for CARBIDOPA

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

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 1
Impax Laboratories, LLCPhase 1
Alexza Pharmaceuticals, Inc.Phase 2

See all CARBIDOPA clinical trials

Generic filers with tentative approvals for CARBIDOPA
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up61.25MG;245MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up48.75MG;195MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up36.25MG;145MGCAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for CARBIDOPA

US Patents and Regulatory Information for CARBIDOPA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-004 Aug 7, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Scs CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 074080-002 Mar 25, 1994 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET, EXTENDED RELEASE;ORAL 077828-001 Aug 23, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aton LODOSYN carbidopa TABLET;ORAL 017830-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Aton LODOSYN carbidopa TABLET;ORAL 017830-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Aton LODOSYN carbidopa TABLET;ORAL 017830-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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