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Generated: October 17, 2018

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Baclofen - Generic Drug Details

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What are the generic drug sources for baclofen and what is the scope of baclofen freedom to operate?

Baclofen is the generic ingredient in four branded drugs marketed by Emerald Intl Ltd, Mylan Labs Ltd, Piramal Critical, Saol Theraps Res Ltd, Ucb Inc, Impax Labs, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Oxford Pharms, Rubicon Res Pvt Ltd, Sun Pharm Inds Inc, Teva, Usl Pharma, Vintage Pharms, Watson Labs, and Novartis, and is included in twenty-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for baclofen. Forty-four suppliers are listed for this compound.

Pharmacology for baclofen
Medical Subject Heading (MeSH) Categories for baclofen

US Patents and Regulatory Information for baclofen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Saol Theraps Res Ltd LIORESAL baclofen INJECTABLE;INTRATHECAL 020075-002 Jun 17, 1992 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Emerald Intl Ltd BACLOFEN baclofen INJECTABLE;INTRATHECAL 091193-003 May 3, 2016 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs BACLOFEN baclofen TABLET;ORAL 077971-002 Oct 26, 2007 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms BACLOFEN baclofen TABLET;ORAL 077068-002 Aug 30, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Usl Pharma BACLOFEN baclofen TABLET;ORAL 071261-001 May 6, 1988 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for baclofen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021589-001 Oct 30, 2003 ➤ Sign Up ➤ Sign Up
Novartis LIORESAL baclofen TABLET;ORAL 017851-001 Approved Prior to Jan 1, 1982 ➤ 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 021589-001 Oct 30, 2003 ➤ Sign Up ➤ Sign Up
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 ➤ 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:

Chinese Patent Office
Cerilliant
Dow
Cantor Fitzgerald
Chubb
Queensland Health
Boehringer Ingelheim
Mallinckrodt
Argus Health

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