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

Last Updated: March 28, 2024

BACLOFEN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Baclofen, and when can generic versions of Baclofen launch?

Baclofen is a drug marketed by Acic Pharms, Amneal, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Ani Pharms, 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, and Zydus. and is included in forty-one NDAs.

The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the baclofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Baclofen

A generic version of BACLOFEN was approved as baclofen by IVAX SUB TEVA PHARMS on July 21st, 1988.

  Try a Trial

Drug patent expirations by year for BACLOFEN
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

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
Watson Labs BACLOFEN baclofen TABLET;ORAL 072824-001 Sep 18, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma BACLOFEN baclofen TABLET;ORAL 215885-002 Jan 25, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Innogenix BACLOFEN baclofen TABLET;ORAL 212378-003 Apr 30, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Northstar Hlthcare BACLOFEN baclofen TABLET;ORAL 078401-001 Sep 18, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds Inc BACLOFEN baclofen TABLET;ORAL 077862-002 Aug 14, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs BACLOFEN baclofen TABLET;ORAL 217687-003 Nov 8, 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

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.