Dutasteride Patent Expiration
Dutasteride is used for treating benign prostatic hyperplasia and other androgen-responsive conditions by inhibiting the 5 alpha testosterone reductase enzyme with dutasteride or its derivatives. It was first introduced by Waylis Therapeutics Llc
Dutasteride Patents
Given below is the list of patents protecting Dutasteride, 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 |
|---|---|---|---|---|
| Avodart | US5565467 | Androstenone derivative |
Nov 20, 2015
(Expired) | Waylis Therap |
| Avodart | US5846976 | Androstenone derivative |
Sep 17, 2013
(Expired) | Waylis Therap |
| Avodart | US5998427 | Androstenones |
Sep 17, 2013
(Expired) | Waylis Therap |
Dutasteride's Family Patents
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Clinical Trials
Recent Clinical Trials on Dutasteride:
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 |
|---|---|---|---|---|
 | ||||
| A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia | Chong Kun Dang Pharmaceutical | NA |
RECRUITING
(Sep 1, 2026)
| PHASE3 |
| A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects | Addpharma Inc. | NA |
RECRUITING
(Mar 1, 2026)
| PHASE1 |