CARBIDOPA, LEVODOPA AND ENTACAPONE Drug Patent Profile
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When do Carbidopa, Levodopa And Entacapone patents expire, and what generic alternatives are available?
Carbidopa, Levodopa And Entacapone is a drug marketed by Norvium Bioscience, Rising, Sun Pharm, and Wockhardt Ltd. and is included in five NDAs.
The generic ingredient in CARBIDOPA, LEVODOPA AND ENTACAPONE is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
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Summary for CARBIDOPA, LEVODOPA AND ENTACAPONE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 23 |
| What excipients (inactive ingredients) are in CARBIDOPA, LEVODOPA AND ENTACAPONE? | CARBIDOPA, LEVODOPA AND ENTACAPONE excipients list |
| DailyMed Link: | CARBIDOPA, LEVODOPA AND ENTACAPONE at DailyMed |
Recent Clinical Trials for CARBIDOPA, LEVODOPA AND ENTACAPONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Affiliated Hospital of Qingdao University | Phase 1 |
| LobSor Pharmaceuticals AB | Phase 1 |
| TFS Trial Form Support | Phase 1 |
Pharmacology for CARBIDOPA, LEVODOPA AND ENTACAPONE
| Drug Class | Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor |
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
US Patents and Regulatory Information for CARBIDOPA, LEVODOPA AND ENTACAPONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norvium Bioscience | CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 203424-001 | Aug 13, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wockhardt Ltd | CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 090833-003 | Nov 20, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 213212-001 | Jan 25, 2022 | 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 |
EU/EMA Drug Approvals for CARBIDOPA, LEVODOPA AND ENTACAPONE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Orion Corporation | Levodopa/Carbidopa/Entacapone Orion | levodopa, carbidopa, entacapone | EMEA/H/C/002441 Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment. |
Authorised | no | no | no | 2011-08-23 | |
| Orion Corporation | Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) | levodopa, carbidopa, entacapone | EMEA/H/C/002785 Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. |
Authorised | no | no | no | 2013-11-11 | |
| Orion Corporation | Stalevo | levodopa, carbidopa, entacapone | EMEA/H/C/000511 Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment. |
Authorised | no | no | no | 2003-10-17 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
