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

See all CARBIDOPA; ENTACAPONE; LEVODOPA clinical trials

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

N04BA	Dopa and dopa derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

N04BX	Other dopaminergic agents
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for CARBIDOPA; ENTACAPONE; LEVODOPA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	213212-005	Jan 25, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt Ltd	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	090833-002	Nov 20, 2012		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
Norvium Bioscience	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	203424-004	Aug 13, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wockhardt Ltd	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	090833-001	Nov 20, 2012		DISCN	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; ENTACAPONE; LEVODOPA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	⤷ Sign Up	⤷ Sign Up
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	⤷ Sign Up	⤷ Sign Up
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	⤷ Sign Up	⤷ Sign Up
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	⤷ Sign Up	⤷ Sign Up
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for CARBIDOPA; ENTACAPONE; LEVODOPA

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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

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