Carbidopa - Generic Drug Details
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What are the generic 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, Edenbridge Pharms, Novel Labs Inc, Regcon Holdings, Zydus Pharms, Aton, Alembic, Macleods Pharms Ltd, Pharmobedient, Rising, Sun Pharm, Wockhardt Ltd, Orion Pharma, Impax, Abbvie, Accord Hlthcare, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon Research, Sciegen Pharms, Sun Pharm Inds, Organon Llc, Ranbaxy, Ucb Inc, Actavis Elizabeth, Apotex Inc, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, SCS, Watson Labs, Avion Pharms, and Organon, and is included in fifty-three NDAs. There are forty patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for carbidopa. Nine suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for carbidopa
| US Patents: | 40 |
| Tradenames: | 18 |
| Applicants: | 37 |
| NDAs: | 53 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 218 |
| 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 |
|---|---|
| University of Arkansas | PHASE1 |
| The Cleveland Clinic | PHASE4 |
| Julien Bally | PHASE1 |
Generic filers with tentative approvals for CARBIDOPA
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 61.25MG;245MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 48.75MG;195MG | CAPSULE, EXTENDED RELEASE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 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 | 217186-001 | Aug 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-001 | Jan 7, 2015 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Impax | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Rubicon Research | CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 216505-001 | Sep 21, 2022 | AB | RX | No | No | ⤷ 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
| 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 | ⤷ Start Trial | ⤷ Start Trial |
| Aton | LODOSYN | carbidopa | TABLET;ORAL | 017830-001 | Approved Prior to Jan 1, 1982 | ⤷ Start Trial | ⤷ Start Trial |
| Aton | LODOSYN | carbidopa | TABLET;ORAL | 017830-001 | Approved Prior to Jan 1, 1982 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Market Dynamics and Financial Trajectory for Carbidopa
More… ↓

