Pramipexole Dihydrochloride Patent Expiration

Pramipexole Dihydrochloride is Used for treating moderate to severe primary Restless Legs Syndrome (RLS). It was first introduced by Boehringer Ingelheim in its drug Mirapex on Jul 1, 1997. Another drug containing Pramipexole Dihydrochloride is Mirapex Er. 25 different companies have introduced drugs containing Pramipexole Dihydrochloride.


Pramipexole Dihydrochloride Patents

Given below is the list of patents protecting Pramipexole Dihydrochloride, 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
Mirapex Er US8679533 Pramipexole once-daily dosage form Sep 08, 2029 Boehringer Ingelheim
Mirapex Er US7695734 Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof Apr 26, 2028 Boehringer Ingelheim
Mirapex US6001861 Use of pramipexole in the treatment of restless legs syndrome Jan 16, 2018

(Expired)

Boehringer Ingelheim
Mirapex US6194445 Use of pramipexole in the treatment of restless legs syndrome Jan 16, 2018

(Expired)

Boehringer Ingelheim



Pramipexole Dihydrochloride's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Pramipexole Dihydrochloride:

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
Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects Haisco Pharmaceutical Group Co., Ltd. NA COMPLETED
(Apr 1, 2026)
PHASE1


Pramipexole Dihydrochloride Generic API Manufacturers

Several generic applications have been filed for Pramipexole Dihydrochloride. The first generic version for Pramipexole Dihydrochloride was by Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc and was approved on Feb 19, 2008. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Nov 23, 2022.

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