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Baclofen - Generic Drug Details

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Baclofen is the generic ingredient in four branded drugs marketed by Northstar Hlthcare, Mylan, Watson Labs, Ivax Sub Teva Pharms, Mylan Pharms Inc, Lannett, Teva, Impax Labs, Novartis, Vintage Pharms, Usl Pharma, Mallinckrodt Inc, Sun Pharm Inds Inc, Saol Theraps Res Ltd, Caraco, Oxford Pharms, Ucb Inc, and Sintetica Sa, and is included in thirty NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirteen patent family members in nine countries.

There are seventeen drug master file entries for baclofen. Forty-five suppliers are listed for this compound.

Summary for Generic Name: baclofen

Tradenames:4
Patents:2
Applicants:18
NDAs:30
Drug Master File Entries: see list17
Suppliers / Packaging: see list45
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: baclofen

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sintetica Sa
BACLOFEN
baclofen
INJECTABLE;INTRATHECAL091193-001May 3, 2016RXNo► subscribe► subscribe
Saol Theraps Res Ltd
LIORESAL
baclofen
INJECTABLE;INTRATHECAL020075-003Nov 7, 1996RXYes► subscribe► subscribe
Watson Labs
BACLOFEN
baclofen
TABLET;ORAL074698-001Aug 20, 1996DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: baclofen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LIORESAL
baclofen
TABLET;ORAL017851-001Approved Prior to Jan 1, 19823,471,548► subscribe
Novartis
LIORESAL
baclofen
TABLET;ORAL017851-003Jan 20, 19823,471,548► subscribe
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International Patent Family for Ingredient: baclofen

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9846215► subscribe
Australia6896998► subscribe
Denmark2147669► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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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