Kemstro Patent Expiration

Kemstro is a drug owned by Ucb Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 09, 2018. Details of Kemstro's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6024981 Rapidly dissolving robust dosage form
Apr, 2018

(8 years ago)

Expired
US6221392 Rapidly dissolving robust dosage form
Apr, 2018

(8 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Kemstro is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Kemstro's family patents as well as insights into ongoing legal events on those patents.

Kemstro's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Kemstro:

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




Generic Launch

Generic Release Date:

Kemstro's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 09, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Kemstro Generic API suppliers:

Baclofen is the generic name for the brand Kemstro. 32 different companies have already filed for the generic of Kemstro, with Rubicon Research having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kemstro's generic

Alternative Brands for Kemstro

There are several other brand drugs using the same active ingredient (Baclofen) as Kemstro. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Azurity
Fleqsuvy
Rosemount
Ozobax
Strides Pharma Intl
Lyvispah


Apart from brand drugs containing the same ingredient, some generics have also been filed for Baclofen, Kemstro's active ingredient. Check the complete list of approved generic manufacturers for Kemstro





About Kemstro

Kemstro is a drug owned by Ucb Inc. Kemstro uses Baclofen as an active ingredient. Kemstro was launched by Ucb in 2003.

Approval Date:

Kemstro was approved by FDA for market use on 30 October, 2003.

Active Ingredient:

Kemstro uses Baclofen as the active ingredient. Check out other Drugs and Companies using Baclofen ingredient

Dosage:

Kemstro is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING Discontinued ORAL
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, ORALLY DISINTEGRATING Discontinued ORAL