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, Heritage, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Piramal Critical, Metacel Pharms Llc, Ani Pharms, Azurity, Ucb Inc, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Endo Operations, Eywa, Graviti Pharms, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Norvium Bioscience, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Watson Labs, Zydus Lifesciences, and Novartis, and is included in forty-eight NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Baclofen has fourteen patent family members in eight countries.

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

Summary for BACLOFEN

International Patents:	14
US Patents:	8
Tradenames:	8
Applicants:	34
NDAs:	48
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	65
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	126
Patent Applications:	6,925
Drug Prices:	Drug price trends for BACLOFEN
Drug Sales Revenues:	Drug sales revenues for BACLOFEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BACLOFEN
What excipients (inactive ingredients) are in BACLOFEN?	BACLOFEN excipients list
DailyMed Link:	BACLOFEN at DailyMed

See drug prices for BACLOFEN

See drug sales revenues for BACLOFEN

Recent Clinical Trials for BACLOFEN

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

Sponsor	Phase
Hospices Civils de Lyon	Phase 2/Phase 3
University of Louisville	Phase 2
Institute of Liver and Biliary Sciences, India	N/A

See all BACLOFEN clinical trials

Generic filers with tentative approvals for BACLOFEN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	5MG/5ML	SOLUTION;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

Drug Class	gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Agonists GABA B Agonists

Medical Subject Heading (MeSH) Categories for BACLOFEN

GABA-B Receptor Agonists
Muscle Relaxants, Central

Anatomical Therapeutic Chemical (ATC) Classes for BACLOFEN

M03BX	Other centrally acting agents
M03B	MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
M03	MUSCLE RELAXANTS
M	Musculo-skeletal system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-002	Nov 22, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mankind Pharma	BACLOFEN	baclofen	TABLET;ORAL	215885-001	Jan 25, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075-002	Jun 17, 1992	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	BACLOFEN	baclofen	TABLET;ORAL	214374-003	Mar 5, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075-001	Jun 17, 1992	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Appco	BACLOFEN	baclofen	TABLET;ORAL	090334-001	Feb 18, 2010		DISCN	No	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

Expired US Patents for BACLOFEN

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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	021589-002	Oct 30, 2003	⤷ Sign Up	⤷ Sign Up
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BACLOFEN

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Country	Patent Number	Title	Estimated Expiration
Mexico	2022001139	FORMULACIONES ESTABILIZADAS DE DERIVADOS DE ACIDO 4-AMINO-3-SUSTITUIDO BUTANOICO. (STABILIZED FORMULATIONS OF 4-AMINO-3-SUBSTITUTED BUTANOIC ACID DERIVATIVES.)	⤷ Sign Up
Japan	7444967		⤷ Sign Up
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)	⤷ Sign Up
Japan	2022544901	４－アミノ－３－置換ブタン酸誘導体の安定化製剤	⤷ Sign Up
Brazil	112022001591	Formulações estabilizadas de derivados do ácido 4-amino-3-butanóico substituídos	⤷ Sign Up
China	109922801	甲硝唑和巴氯芬的混悬剂和稀释剂 (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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