STALEVO 200 Drug Patent Profile

When do Stalevo 200 patents expire, and when can generic versions of Stalevo 200 launch?

Stalevo 200 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 200 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 STALEVO 200

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
Patent Applications:	20
Formulation / Manufacturing:	see details
DailyMed Link:	STALEVO 200 at DailyMed

Recent Clinical Trials for STALEVO 200

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Asan Medical Center	N/A
SynAgile Corporation	Phase 2

See all STALEVO 200 clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for STALEVO 200

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 STALEVO 200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007	AB	RX	Yes	Yes

Expired US Patents for STALEVO 200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007

EU/EMA Drug Approvals for STALEVO 200

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

International Patents for STALEVO 200

See the table below for patents covering STALEVO 200 around the world.

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	48020
Germany	19975025
United Kingdom	2200109	NEW PHARMACOLOGICALLY ACTIVE COMPOUNDS, METHODS FOR THE PREPARATION THEREOF AND COMPOSITIONS CONTAINING THE SAME
South Korea	960004771

Supplementary Protection Certificates for STALEVO 200

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0426468	0490007-2	Sweden		PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0426468	91071	Luxembourg		91071, EXPIRES: 20151101
0426468	CA 2004 00007	Denmark