TOPOTECAN Drug Patent Profile

✉ Email this page to a colleague

Topotecan is a drug marketed by Sandoz Inc, 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 sixteen NDAs.

The generic ingredient in TOPOTECAN 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.

A generic version of TOPOTECAN was approved as topotecan hydrochloride by FRESENIUS KABI USA on November 29^th, 2010.

US Patents:	0
Applicants:	13
NDAs:	16
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	434
Patent Applications:	2,113
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TOPOTECAN
What excipients (inactive ingredients) are in TOPOTECAN?	TOPOTECAN excipients list
DailyMed Link:	TOPOTECAN at DailyMed

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

L01CE	Topoisomerase 1 (TOP1) inhibitors
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Subscribe to access the full database, or 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
Sandoz Inc	TOPOTECAN	topotecan hydrochloride	SOLUTION;INTRAVENOUS	200199-001	Feb 25, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira Inc	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	SOLUTION;INTRAVENOUS	200582-001	Feb 2, 2011	AP	RX	Yes	Yes	⤷ 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	INJECTABLE;INJECTION	202351-001	Jun 26, 2013	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sagent Pharms	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	INJECTABLE;INJECTION	091284-001	Jan 26, 2011	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	INJECTABLE;INJECTION	091376-001	Nov 29, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Meitheal	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	SOLUTION;INTRAVENOUS	022453-001	Dec 20, 2012	AP	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