CARBIDOPA; ENTACAPONE; LEVODOPA - Generic Drug Details
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What are the generic drug sources for carbidopa; entacapone; levodopa and what is the scope of freedom to operate?
Carbidopa; entacapone; levodopa
is the generic ingredient in seven branded drugs marketed by Norvium Bioscience, Rising, Sun Pharm, Wockhardt Ltd, and Orion Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.Three suppliers are listed for this compound.
Summary for CARBIDOPA; ENTACAPONE; LEVODOPA
US Patents: | 0 |
Tradenames: | 7 |
Applicants: | 5 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 23 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CARBIDOPA; ENTACAPONE; LEVODOPA |
DailyMed Link: | CARBIDOPA; ENTACAPONE; LEVODOPA at DailyMed |
Recent Clinical Trials for CARBIDOPA; ENTACAPONE; LEVODOPA
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; ENTACAPONE; LEVODOPA
Drug Class | Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor |
Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CARBIDOPA; ENTACAPONE; LEVODOPA
US Patents and Regulatory Information for CARBIDOPA; ENTACAPONE; LEVODOPA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wockhardt Ltd | CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 090786-001 | Nov 20, 2012 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Sun Pharm | CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 079085-002 | May 10, 2012 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Norvium Bioscience | CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 203424-004 | Aug 13, 2020 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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; ENTACAPONE; LEVODOPA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Orion Pharma | STALEVO 50 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-001 | Jun 11, 2003 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | STALEVO 125 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-006 | Aug 29, 2008 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | STALEVO 150 | carbidopa; entacapone; levodopa | TABLET;ORAL | 021485-003 | Jun 11, 2003 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for CARBIDOPA; ENTACAPONE; LEVODOPA
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 |
CARBIDOPA; ENTACAPONE; LEVODOPA Market Analysis and Financial Projection Experimental
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