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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Cipla
Fish and Richardson
Queensland Health
US Department of Justice
Express Scripts
Colorcon
McKesson
Harvard Business School

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021485

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NDA 021485 describes STALEVO 75, which 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. Additional details are available on the STALEVO 75 profile page.

The generic ingredient in STALEVO 75 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 021485
Tradename:STALEVO 75
Applicant:Orion Pharma
Ingredient:carbidopa; entacapone; levodopa
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021485
Suppliers and Packaging for NDA: 021485
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA Novartis Pharmaceuticals Corporation 0078-0407 N 0078-0407-05
STALEVO 100 carbidopa; entacapone; levodopa TABLET;ORAL 021485 NDA Novartis Pharmaceuticals Corporation 0078-0408 N 0078-0408-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;200MG;50MG
Approval Date:Jun 11, 2003TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE
Patent:➤ Sign UpPatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;200MG;100MG
Approval Date:Jun 11, 2003TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

Expired US Patents for NDA 021485

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 ➤ 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 75 carbidopa; entacapone; levodopa TABLET;ORAL 021485-005 Aug 29, 2008 ➤ 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

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Cipla
Farmers Insurance
Moodys
Dow
QuintilesIMS
Baxter
McKesson
Express Scripts

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