CARBIDOPA, LEVODOPA AND ENTACAPONE Drug Patent Profile

When do Carbidopa, Levodopa And Entacapone patents expire, and what generic alternatives are available?

Carbidopa, Levodopa And Entacapone is a drug marketed by Mylan, 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. Four suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for CARBIDOPA, LEVODOPA AND ENTACAPONE

US Patents:	0
Applicants:	4
NDAs:	5
Finished Product Suppliers / Packagers:	1
Clinical Trials:	22
Formulation / Manufacturing:	see details
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
LobSor Pharmaceuticals AB	Phase 1
TFS Trial Form Support	Phase 1
Asan Medical Center	N/A

See all CARBIDOPA, LEVODOPA AND ENTACAPONE clinical trials

Pharmacology for CARBIDOPA, LEVODOPA AND ENTACAPONE

Drug Class	Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CARBIDOPA, LEVODOPA AND ENTACAPONE

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, 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
Mylan	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	203424-001	Aug 13, 2020		DISCN	No	No
Wockhardt Ltd	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	090833-003	Nov 20, 2012		DISCN	No	No
Rising	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	213212-001	Jan 25, 2022	AB	RX	No	No
Mylan	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	203424-004	Aug 13, 2020		DISCN	No	No
Rising	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	213212-006	Jan 25, 2022	AB	RX	No	No
Wockhardt Ltd	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	090833-005	Nov 20, 2012		DISCN	No	No

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