Baclofen Patent Expiration

Baclofen was first introduced by Novartis Pharmaceuticals Corp in its drug Lioresal on Approved Prior to Jan 1, 1982. Other drugs containing Baclofen are Kemstro, Lyvispah, Ozobax, Ozobax Ds, Gablofen, Fleqsuvy. 37 different companies have introduced drugs containing Baclofen.


Baclofen Patents

Given below is the list of patents protecting Baclofen, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lyvispah US11491125 Baclofen formulations and methods of minimizing patient exposure to metabolite variations Sep 29, 2041 Strides Pharma Intl
Lyvispah US11850225 Baclofen formulations and methods of minimizing patient exposure to metabolite variations Sep 29, 2041 Strides Pharma Intl
Ozobax US10610502 Oral baclofen solutions Aug 30, 2039 Rosemount
Lyvispah US10792262 Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Jul 29, 2039 Strides Pharma Intl
Lyvispah US11654124 Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Jul 29, 2039 Strides Pharma Intl
Lyvispah US11931328 Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Jul 29, 2039 Strides Pharma Intl
Fleqsuvy US11324696 Suspensions and diluents for metronidazole and baclofen Sep 29, 2037 Azurity
Fleqsuvy US11446246 Suspensions and diluents for metronidazole and baclofen Sep 08, 2037 Azurity
Kemstro US6024981 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

Ucb Inc
Kemstro US6221392 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

Ucb Inc



Baclofen's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Baclofen:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th Hospital General Universitario Gregorio Marañon NA RECRUITING
(Jun 1, 2026)
PHASE3
Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence Hospices Civils de Lyon NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
Vaginal Baclofen Suppositories in Chronic Pelvic Pain University of Louisville NA COMPLETED
(Apr 1, 2026)
PHASE2
Multiprofen-CC to Reduce Pain in Hand Arthritis St. Joseph's Healthcare Hamilton NA RECRUITING
(Apr 1, 2026)
PHASE3
Baclofen for Children With Rumination Syndrome Nationwide Children's Hospital NA COMPLETED
(Mar 1, 2026)
PHASE3
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury Kessler Foundation NA RECRUITING
(Mar 1, 2026)
PHASE1


Baclofen Generic API Manufacturers

Several generic applications have been filed for Baclofen. The first generic version for Baclofen was by Usl Pharma Inc and was approved on May 6, 1988. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Nov 21, 2025.

Given below is the list of companies who have filed for Baclofen generic, along with the locations of their manufacturing plants worldwide.


Baclofen News

Metacel Pharmaceuticals, LLC vs. Rubicon Research Private Limited | Robins Kaplan LLP - JDSupra

01 Aug, 2025

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