TOPOTECAN Drug Patent Profile
✉ Email this page to a colleague
When do Topotecan patents expire, and when can generic versions of Topotecan launch?
Topotecan is a drug marketed by Sandoz Inc, Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Novast Labs, Rising, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Dash Pharms, and Hospira Inc. and is included in sixteen NDAs.
The generic ingredient in TOPOTECAN is topotecan hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Topotecan
A generic version of TOPOTECAN was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29th, 2010.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TOPOTECAN?
- What are the global sales for TOPOTECAN?
- What is Average Wholesale Price for TOPOTECAN?
Summary for TOPOTECAN
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 438 |
| Patent Applications: | 2,067 |
| Drug Prices: | Drug price information for TOPOTECAN |
| What excipients (inactive ingredients) are in TOPOTECAN? | TOPOTECAN excipients list |
| DailyMed Link: | TOPOTECAN at DailyMed |
Recent Clinical Trials for TOPOTECAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GOG Foundation | Phase 3 |
| Verastem, Inc. | Phase 3 |
| Luye Pharma Group Ltd. | Phase 3 |
US Patents and Regulatory Information for TOPOTECAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz Inc | TOPOTECAN | topotecan hydrochloride | SOLUTION;INTRAVENOUS | 200199-001 | Feb 25, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira Inc | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | SOLUTION;INTRAVENOUS | 200582-001 | Feb 2, 2011 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fresenius Kabi Usa | TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 091089-001 | Nov 29, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
