STALEVO 100 Drug Patent Profile

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Which patents cover Stalevo 100, and when can generic versions of Stalevo 100 launch?

Stalevo 100 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 100 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 100

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
Patent Applications:	21
Formulation / Manufacturing:	see details
DailyMed Link:	STALEVO 100 at DailyMed

Drug patent expirations by year for STALEVO 100

Recent Clinical Trials for STALEVO 100

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 100 clinical trials

Pharmacology for STALEVO 100

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

Anatomical Therapeutic Chemical (ATC) Classes for STALEVO 100

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 100

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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
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 STALEVO 100

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	⤷ Try a Trial	⤷ Try a Trial
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	⤷ Try a Trial	⤷ Try a Trial
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	⤷ Try a Trial	⤷ Try a Trial
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	⤷ Try a Trial	⤷ Try a Trial
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	⤷ Try a Trial	⤷ Try a Trial
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for STALEVO 100

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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

International Patents for STALEVO 100

See the table below for patents covering STALEVO 100 around the world.

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Country	Patent Number	Title	Estimated Expiration
Netherlands	300147		⤷ Try a Trial
Morocco	21120		⤷ Try a Trial
Sweden	503434	Nya farmakologiskt aktiva katekolderivat, förfaranden för deras framställning, kompositioner innehållande dessa samt användning av dessa för framställning av läkemedel	⤷ Try a Trial
Yugoslavia	48020		⤷ Try a Trial
Iceland	1753		⤷ Try a Trial
Greece	3017526		⤷ Try a Trial
U.S.S.R.	1729291	CПOCOБ ПOЛУЧEHИЯ ПPOИЗBOДHЫX KATEXИHA (METHOD OF CATCHING DERIVATIVES SYNTHESIS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for STALEVO 100

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

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