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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 Hydrochloride, Topotecan. 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 US8158645 Compound, corresponding compositions, preparation and/or treatment methods Dec 10, 2024 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

Family Patents

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Topotecan Hydrochloride Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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. 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


Manufacturing Plant Locations
New

Actavis Totowa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Totowa as present at those locations.

Country City Firm Name
United States
Totowa Actavis Totowa LLC
Little Falls Actavis Totowa LLC





3. 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





4. 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





5. 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


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Melrose Park Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC
North Andover Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Melrose Park Fresenius Kabi USA LLC
Lake Zurich Fresenius Kabi USA, LLC





6. 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





7. 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





8. 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


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Phoenix Rising Sun Farms Inc
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





9. 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





10. 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





11. 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