You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 24, 2024

BACLOFEN - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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.

Drug Prices for BACLOFEN

See drug prices for BACLOFEN

Drug Sales Revenue Trends for BACLOFEN

See drug sales revenues for BACLOFEN

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
⤷  Sign Up⤷  Sign Up5MG/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
Amneal LYVISPAH baclofen GRANULES;ORAL 215422-002 Nov 22, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan BACLOFEN baclofen TABLET;ORAL 077121-002 Jul 29, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Maia Pharms Inc BACLOFEN baclofen INJECTABLE;INTRATHECAL 210315-001 Jul 30, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva BACLOFEN baclofen TABLET;ORAL 073043-001 Feb 27, 1992 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Piramal Critical GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462-002 Nov 19, 2010 AP RX Yes Yes ⤷  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

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 017851-003 Jan 20, 1982 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BACLOFEN

Country Patent Number Title Estimated Expiration
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
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) ⤷  Sign Up
European Patent Office 3509592 SUSPENSIONS ET DILUANTS POUR LE MÉTRONIDAZOLE ET LE BACLOFÈNE (SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN) ⤷  Sign Up
Australia 2020323846 Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2021021277 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.