Simvastatin Patent Expiration
Simvastatin was first introduced by Organon Llc A Sub Of Organon And Co
Simvastatin Patents
Given below is the list of patents protecting Simvastatin, 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 |
|---|---|---|---|---|
| Flolipid | US9597289 | Liquid oral simvastatin compositions | Feb 23, 2030 | Salerno Pharms |
| Flolipid | US10300041 | Liquid oral simvastatin compositions | Apr 26, 2027 | Salerno Pharms |
Simvastatin's Family Patents
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Clinical Trials
Recent Clinical Trials on Simvastatin:
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 |
|---|---|---|---|---|
 | ||||
| VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma | Inova Health Care Services | NA |
RECRUITING
(Sep 1, 2026)
| PHASE2 |
| Effects of Simvastatin on Uterine Leiomyoma Size | Johns Hopkins University | NA |
ACTIVE NOT RECRUITING
(Jul 1, 2026)
| PHASE2 |
| RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial | McGill University Health Centre/Research Institute of the McGill University Health Centre | NA |
NOT YET RECRUITING
(Jul 1, 2026)
| PHASE2 |
| Topical 2% Simvastatin for Xanthelasma Palpebrarum | Klira Skin | NA |
NOT YET RECRUITING
(Jun 1, 2026)
| PHASE2 |
| Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility and Outcomes | Columbia University | NA |
TERMINATED
(Apr 1, 2026)
| PHASE3 |