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Profile for Tradename: STALEVO 125

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Stalevo 125 is a drug marketed by Orion Pharma and is included in one NDA. It is available from six suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in forty countries.

The generic ingredient in STALEVO 125 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for Tradename: STALEVO 125

Patents:2
Applicants:1
NDAs:1
Suppliers: see list6
Formulation / Manufacturing:see details

Clinical Trials for: STALEVO 125

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 2008RXNo6,500,867<disabled>Y<disabled>
Orion Pharma
STALEVO 125
carbidopa; entacapone; levodopa
TABLET;ORAL021485-006Aug 29, 2008RXNo6,797,732<disabled>Y<disabled>
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Paragraph IV activity for: STALEVO 125

Drugname Dosage Strength RLD Submissiondate
carbidopa, levodopa and entacaponeTablets18.75 mg/75 mg/200 mg and 31.25 mg/125 mg/200 mgStalevo 1255/19/2009

International Patent Family for Tradename: STALEVO 125

Country Document Number Publication Date
Bulgaria65364Apr 30, 2008
Germany60004052Aug 28, 2003
France2797587Feb 23, 2001
Colombia5180579Jul 30, 2002
MexicoPA01013167Jul 02, 2002
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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