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 in its drug Hycamtin on May 28, 1996. Other drugs containing Topotecan Hydrochloride are Topotecan, Topotecan Hydrochloride. 14 different companies have introduced drugs containing Topotecan Hydrochloride.


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 US5674872 Treatment of ovarian cancer Oct 07, 2014

(Expired)

Sandoz
Hycamtin US5674872

(Pediatric)

Treatment of ovarian cancer Apr 07, 2015

(Expired)

Sandoz
Hycamtin US8158645 Compound, corresponding compositions, preparation and/or treatment methods Dec 10, 2024 Sandoz


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Topotecan Hydrochloride Generics

Several generic applications have been filed for Topotecan Hydrochloride. The first generic version for Topotecan Hydrochloride was by Fresenius Kabi Usa Llc and was approved on Nov 29, 2010. And the latest generic version is by Dash Pharmaceuticals Llc and was approved on Nov 24, 2017.

Given below is the list of companies who have filed for Topotecan Hydrochloride generic.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 3 different strengths of generic version for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Prescription INJECTION AP Jun 26, 2013
EQ 1MG BASE/ML (EQ 1MG BASE/ML) solution Prescription INTRAVENOUS N/A Jul 6, 2017
EQ 4MG BASE/4ML (EQ 1MG BASE/ML) solution Prescription INTRAVENOUS AP Jul 6, 2017


2. SAGENT PHARMS

Sagent Pharmaceuticals Inc has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Sagent Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Prescription INJECTION AP Jan 26, 2011


3. TEYRO LABS

Teyro Labs Private Ltd has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Teyro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Prescription INJECTION AP Dec 1, 2010


4. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Discontinued INJECTION N/A Aug 28, 2012


5. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Prescription INJECTION AP Mar 9, 2011


6. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Prescription INJECTION AP Nov 29, 2010


7. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Discontinued INJECTION N/A Aug 29, 2013


8. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Discontinued INJECTION N/A Aug 8, 2012


9. NOVAST LABS

Novast Laboratories Ltd has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Prescription INJECTION AP Nov 30, 2016


10. ACTAVIS TOTOWA

Actavis Totowa Llc has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Totowa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/VIAL injectable Prescription INJECTION AP Dec 2, 2010


11. DASH PHARMS

Dash Pharmaceuticals Llc has filed for 1 generic for Topotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Dash Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 4MG BASE/4ML (EQ 1MG BASE/ML) solution Discontinued INTRAVENOUS N/A Nov 24, 2017