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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
Daiichi Sankyo
McKinsey
Harvard Business School
Johnson and Johnson
Boehringer Ingelheim
Fuji
Dow

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021589

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NDA 021589 describes KEMSTRO, which is a drug marketed by Ucb Inc and is included in one NDA. There are two patents protecting this drug. Additional details are available on the KEMSTRO profile page.

The generic ingredient in KEMSTRO is baclofen. There are nineteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 021589
Tradename:KEMSTRO
Applicant:Ucb Inc
Ingredient:baclofen
Patents:2
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021589

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Oct 30, 2003TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength20MG
Approval Date:Oct 30, 2003TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Apr 9, 2018Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021589

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-001 Oct 30, 2003 ➤ Sign Up ➤ Sign Up
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-001 Oct 30, 2003 ➤ Sign Up ➤ Sign Up
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 2003 ➤ Sign Up ➤ Sign Up
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 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:

Merck
Chubb
QuintilesIMS
Cantor Fitzgerald
Mallinckrodt
Queensland Health
Daiichi Sankyo
Chinese Patent Office
Fish and Richardson

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