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Last Updated: March 28, 2024

BACLOFEN - Generic Drug Details


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

Baclofen is the generic ingredient in eight branded drugs marketed by Amneal, Acic Pharms, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Piramal Critical, Metacel Pharms Llc, Ani Pharms, Azurity, Ucb Inc, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Eywa Pharma, Graviti Pharms, Impax, Innogenix, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Mylan, Northstar Hlthcare, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Vintage Pharms, Watson Labs, Zydus, and Novartis, and is included in forty-eight NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baclofen has thirteen patent family members in eight countries.

There are twenty-one drug master file entries for baclofen. Sixty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for BACLOFEN

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Drug Sales Revenue Trends for BACLOFEN

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Recent Clinical Trials for BACLOFEN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kuwait UniversityEarly Phase 1
Marmara UniversityN/A
European University of LefkeN/A

See all BACLOFEN clinical trials

Generic filers with tentative approvals for BACLOFEN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial5MG/5MLSOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BACLOFEN
Medical Subject Heading (MeSH) Categories for BACLOFEN
Paragraph IV (Patent) Challenges for BACLOFEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FLEQSUVY Oral Suspension baclofen 25 mg/5 mL 215602 1 2022-05-20
OZOBAX DS Oral Solution baclofen 5 mg/5 mL 208193 1 2021-07-26

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
Unichem BACLOFEN baclofen TABLET;ORAL 212067-001 Jul 9, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd BACLOFEN baclofen INJECTABLE;INTRATHECAL 209592-002 Mar 21, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Oxford Pharms BACLOFEN baclofen TABLET;ORAL 077088-001 Oct 31, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Maia Pharms Inc BACLOFEN baclofen INJECTABLE;INTRATHECAL 210315-001 Jul 30, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Unichem BACLOFEN baclofen TABLET;ORAL 212067-003 Mar 9, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan BACLOFEN baclofen TABLET;ORAL 077121-002 Jul 29, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Beximco Pharms Usa BACLOFEN baclofen TABLET;ORAL 214114-003 Sep 19, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 021589-001 Oct 30, 2003 ⤷  Try a Trial ⤷  Try a Trial
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-001 Oct 30, 2003 ⤷  Try a Trial ⤷  Try a Trial
Novartis LIORESAL baclofen TABLET;ORAL 017851-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 2003 ⤷  Try a Trial ⤷  Try a Trial
Ucb Inc KEMSTRO baclofen TABLET, ORALLY DISINTEGRATING;ORAL 021589-002 Oct 30, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BACLOFEN

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2023055457 ⤷  Try a Trial
European Patent Office 4003323 FORMULATIONS STABILISÉES DE DÉRIVÉS DE L'ACIDE BUTANOÏQUE DU TYPE 4-AMINO-3-SUBSTITUÉS (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES) ⤷  Try a Trial
Brazil 112022001591 Formulações estabilizadas de derivados do ácido 4-amino-3-butanóico substituídos ⤷  Try a Trial
China 114450002 4-氨基-3-取代的丁酸衍生物的稳定制剂 (Stable formulations of 4-amino-3-substituted butyric acid derivatives) ⤷  Try a Trial
Japan 2022544901 4-アミノ-3-置換ブタン酸誘導体の安定化製剤 ⤷  Try a Trial
Canada 3148812 FORMULATIONS STABILISEES DE DERIVES DE L'ACIDE BUTANOIQUE DU TYPE 4-AMINO-3-SUBSTITUES (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018049184 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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