Topotecan Hydrochloride Patent Expiration
Topotecan Hydrochloride is Used for treating metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. It was first introduced by Sandoz Inc
Topotecan Hydrochloride Patents
Given below is the list of patents protecting Topotecan Hydrochloride, 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 |
|---|---|---|---|---|
| Hycamtin | US8158645 | Compound, corresponding compositions, preparation and/or treatment methods |
Dec 10, 2024
(Expired) | Sandoz |
| Hycamtin |
US5674872 (Pediatric) | Treatment of ovarian cancer |
Apr 07, 2015
(Expired) | Sandoz |
| Hycamtin | US5674872 | Treatment of ovarian cancer |
Oct 07, 2014
(Expired) | Sandoz |
Topotecan Hydrochloride's Family Patents
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Clinical Trials
Recent Clinical Trials on Topotecan Hydrochloride:
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 |
|---|---|---|---|---|
 | ||||
| Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs | National Cancer Institute (NCI) | NA |
ACTIVE NOT RECRUITING
(Jun 1, 2026)
| PHASE2 |
| A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer (TAISHAN-302) | MediLink Therapeutics (Suzhou) Co., Ltd. | NA |
ACTIVE NOT RECRUITING
(May 1, 2026)
| PHASE3 |