BACLOFEN - Generic Drug Details

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 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-four 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:	64
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	121
Patent Applications:	6,724
Formulation / Manufacturing:	see details
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
Kuwait University	Early Phase 1
Marmara University	N/A
European University of Lefke	N/A

See all BACLOFEN clinical trials

Generic filers with tentative approvals for BACLOFEN

Applicant	Application No.	Strength	Dosage Form
		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

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
Mylan	BACLOFEN	baclofen	TABLET;ORAL	077181-001	Jul 29, 2005		DISCN	No	No
Maia Pharms Inc	BACLOFEN	baclofen	INJECTABLE;INTRATHECAL	210048-002	Sep 11, 2019	AP	RX	No	No
Maia Pharms Inc	BACLOFEN	baclofen	INJECTABLE;INTRATHECAL	210777-001	Jan 15, 2021	AP	RX	No	No
Aurobindo Pharma Ltd	BACLOFEN	baclofen	TABLET;ORAL	214099-001	Jul 13, 2021	AB	RX	No	No
Ivax Sub Teva Pharms	BACLOFEN	baclofen	TABLET;ORAL	072235-001	Jul 21, 1988	AB	RX	No	Yes
Zydus Lifesciences	BACLOFEN	baclofen	TABLET;ORAL	211659-001	Nov 23, 2018	AB	RX	No	No
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422-001	Nov 22, 2021		RX	Yes	No			Y

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
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 1982
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-001	Approved Prior to Jan 1, 1982
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-002	Oct 30, 2003
Ucb Inc	KEMSTRO	baclofen	TABLET, ORALLY DISINTEGRATING;ORAL	021589-001	Oct 30, 2003

International Patents for BACLOFEN

Country	Patent Number	Title	Estimated Expiration
Australia	2020323846	Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
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)
Canada	3036356	SUSPENSIONS ET DILUANTS POUR LE METRONIDAZOLE ET LE BACLOFENE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)
World Intellectual Property Organization (WIPO)	2023055457
World Intellectual Property Organization (WIPO)	2018049184
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)
China	109922801	甲硝唑和巴氯芬的混悬剂和稀释剂 (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN)