TOPOTECAN HYDROCHLORIDE Drug Patent Profile
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Which patents cover Topotecan Hydrochloride, and what generic alternatives are available?
Topotecan Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Dash Pharms, and Hospira Inc. and is included in fifteen NDAs.
The generic ingredient in TOPOTECAN HYDROCHLORIDE is topotecan hydrochloride. There are ten drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Topotecan Hydrochloride
A generic version of TOPOTECAN HYDROCHLORIDE was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29th, 2010.
Summary for TOPOTECAN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 108 |
| Clinical Trials: | 434 |
| Patent Applications: | 7,181 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TOPOTECAN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for TOPOTECAN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amgen | Phase 3 |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Phase 2 |
| Bristol-Myers Squibb | Phase 2 |
Pharmacology for TOPOTECAN HYDROCHLORIDE
| Drug Class | Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for TOPOTECAN HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for TOPOTECAN HYDROCHLORIDE
US Patents and Regulatory Information for TOPOTECAN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 202351-001 | Jun 26, 2013 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Labs Ltd | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 091542-001 | Aug 28, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 091089-001 | Nov 29, 2010 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Accord Hlthcare | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | SOLUTION;INTRAVENOUS | 204406-001 | Jul 6, 2017 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
