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