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
US Patents: | 21 |
Tradenames: | 18 |
Applicants: | 35 |
NDAs: | 50 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 210 |
Patent Applications: | 5,755 |
Drug Prices: | Drug price trends for CARBIDOPA |
What excipients (inactive ingredients) are in CARBIDOPA? | CARBIDOPA excipients list |
DailyMed Link: | CARBIDOPA at DailyMed |
Recent Clinical Trials for CARBIDOPA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Affiliated Hospital of Qingdao University | Phase 1 |
Impax Laboratories, LLC | Phase 1 |
Alexza Pharmaceuticals, Inc. | Phase 2 |
Generic filers with tentative approvals for CARBIDOPA
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 61.25MG;245MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 48.75MG;195MG | CAPSULE, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 36.25MG;145MG | CAPSULE, 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 |