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Irinotecan Hydrochloride Patent Expiration

Irinotecan Hydrochloride is used for treating metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin, and irinotecan. It was first introduced by Pfizer Inc in its drug Camptosar on Jun 14, 1996. Another drug containing Irinotecan Hydrochloride is Onivyde. 25 different companies have introduced drugs containing Irinotecan Hydrochloride.


Irinotecan Hydrochloride Patents

Given below is the list of patents protecting Irinotecan 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
Onivyde US10456360 Stabilizing camptothecin pharmaceutical compositions Oct 15, 2036 Ipsen
Onivyde US10993914 Stabilizing camptothecin pharmaceutical compositions Oct 15, 2036 Ipsen
Onivyde US12059497 Stabilizing camptothecin pharmaceutical compositions Oct 15, 2036 Ipsen
Onivyde US11344552 Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin Aug 19, 2036 Ipsen
Onivyde US10980795 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan Jun 12, 2033 Ipsen
Onivyde US11369597 Methods for treating pancreatic cancer using combination therapies Jun 12, 2033 Ipsen
Onivyde US9339497 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan Jun 12, 2033 Ipsen
Onivyde US9364473 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan Jun 12, 2033 Ipsen
Onivyde US9452162 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan Jun 12, 2033 Ipsen
Onivyde US9492442 Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan Jun 12, 2033 Ipsen
Onivyde US9717724 Methods for treating pancreatic cancer using combination therapies Jun 12, 2033 Ipsen
Onivyde US8147867 Liposomes useful for drug delivery Aug 29, 2028 Ipsen
Onivyde US8329213 Liposomes useful for drug delivery Jan 06, 2027 Ipsen
Onivyde US10722508 Liposomes useful for drug delivery May 02, 2025

(Expired)

 Ipsen
Onivyde US8703181 Liposomes useful for drug delivery May 02, 2025

(Expired)

 Ipsen
Onivyde US8992970 Liposomes useful for drug delivery May 02, 2025

(Expired)

 Ipsen
Onivyde US9724303 Liposomes useful for drug delivery May 02, 2025

(Expired)

 Ipsen
Onivyde US9730891 Liposomes useful for drug delivery May 02, 2025

(Expired)

 Ipsen
Onivyde US9782349 Liposomes useful for drug delivery May 02, 2025

(Expired)

 Ipsen
Camptosar US6794370

(Pediatric)

 Method for treating cancer using camptothecin derivatives and 5-fluorouracil Nov 01, 2020

(Expired)

 Pfizer Inc
Camptosar US6403569

(Pediatric)

 Method for treating cancer using camptothecin derivatives and 5-fluorouracil Oct 28, 2020

(Expired)

 Pfizer Inc
Camptosar US6794370 Method for treating cancer using camptothecin derivatives and 5-fluorouracil May 01, 2020

(Expired)

 Pfizer Inc
Camptosar US6403569 Method for treating cancer using camptothecin derivatives and 5-fluorouracil Apr 28, 2020

(Expired)

 Pfizer Inc



Irinotecan Hydrochloride's Family Patents

Family Patents

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Irinotecan Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Irinotecan Hydrochloride. The first generic version for Irinotecan Hydrochloride was by Cipla Ltd and was approved on Feb 20, 2008. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Apr 11, 2022.

Given below is the list of companies who have filed for Irinotecan Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Irinotecan 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
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Nov 21, 2008
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Nov 21, 2008





2. ACTAVIS TOTOWA

Actavis Totowa Llc has filed for 3 different strengths of generic version for Irinotecan 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
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Feb 27, 2008
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Feb 27, 2008
500MG/25ML (20MG/ML)

injectable Prescription INJECTION AP Nov 18, 2015


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. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Apr 15, 2010
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Apr 15, 2010





4. CIPLA LTD

Cipla Ltd has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Cipla Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 20, 2008
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 20, 2008


Manufacturing Plant Locations
New

Cipla Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla Ltd as present at those locations.

Country City Firm Name
India
Bangalore Cipla Ltd.





5. EMCURE PHARMS LTD

Emcure Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Emcure Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 14, 2012
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 14, 2012





6. EPIC PHARMA LLC

Epic Pharma Llc has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Sep 16, 2009
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Sep 16, 2009





7. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 4 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Nov 2, 2020
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Nov 2, 2020
300MG/15ML (20MG/ML)

injectable Prescription INJECTION AP Nov 2, 2020
500MG/25ML (20MG/ML)

injectable Prescription INJECTION AP Apr 11, 2022


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





8. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Irinotecan 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
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 27, 2008
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 27, 2008


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
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
Lake Zurich Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC





9. GLAND

Gland Pharma Ltd has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Nov 18, 2019
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Nov 18, 2019


Manufacturing Plant Locations
New

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

Country City Firm Name
India
Sriperumbudur Gland Chemical Private Limited
Visakhapatnam Gland Pharma Limited
Hyderabad Gland Pharma Limited
Parawada, Visakhapatnam Gland Pharma Limited
Malur Gland Chemicals Pvt Ltd.
Aurangabad Gland Chemical Private Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site





10. HENGRUI PHARMA

Jiangsu Hengrui Pharmaceuticals Co Ltd has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Hengrui Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Dec 16, 2011
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Dec 16, 2011





11. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Dec 24, 2008
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Dec 24, 2008


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





12. HIKMA FARMACEUTICA

Hikma Farmaceutica (portugal) Sa has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma Farmaceutica.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Dec 20, 2010
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Dec 20, 2010


Manufacturing Plant Locations
New

Hikma Farmaceutica's manufacturing plants are situated in 1 country - Portugal. Given below are the details of these plant locations as well as the firm names of Hikma Farmaceutica as present at those locations.

Country City Firm Name
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.





13. HISUN PHARM HANGZHOU

Hisun Pharmaceutical (hangzhou) Co Ltd has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Hisun Pharm Hangzhou.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Jan 28, 2009
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Jan 28, 2009





14. HOSPIRA

Hospira Inc has filed for 3 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Feb 27, 2008
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Feb 27, 2008
500MG/25ML (20MG/ML)

(reference standard)

injectable Prescription INJECTION AP Feb 27, 2008


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Rocky Mount Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Mcpherson Hospira, Inc., A Pfizer Company
Lake Forest Hospira Inc
Morgan Hill Hospira Inc
Clayton Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





15. INTAS PHARMS USA

Intas Pharmaceuticals Usa has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Intas Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Aug 31, 2017
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Aug 31, 2017





16. NOVAST LABS

Novast Laboratories Ltd has filed for 2 different strengths of generic version for Irinotecan 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
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP May 26, 2017
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP May 26, 2017





17. PLIVA LACHEMA

Pliva Lachema As has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Pliva Lachema.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Oct 31, 2008
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Oct 31, 2008





18. QILU PHARM HAINAN

Qilu Pharmaceutical Hainan Co Ltd has filed for 3 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Qilu Pharm Hainan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP May 3, 2016
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP May 3, 2016
300MG/15ML (20MG/ML)

injectable Prescription INJECTION AP May 3, 2016





19. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Nov 12, 2009
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Nov 12, 2009


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





20. SHILPA

Shilpa Medicare Ltd has filed for 3 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Shilpa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP Dec 28, 2018
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP Dec 28, 2018
300MG/15ML (20MG/ML)

injectable Prescription INJECTION AP Aug 16, 2019


Manufacturing Plant Locations
New

Shilpa's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Shilpa as present at those locations.

Country City Firm Name
United States
Minneapolis Shilpa Gupta
India
Chicksugur, Raichur Shilpa Pharma Lifesciences Limited
Bengaluru Shilpa Medicare Limited
Hyderabad Shilpa Medicare Limited
Polepally, Jadcherla Shilpa Medicare Limited
Hyderbad Shilpa Medicare Limited





21. SUN PHARMA GLOBAL

Sun Pharma Global Inc has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharma Global.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Apr 21, 2008
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Apr 21, 2008





22. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 27, 2008
40MG/2ML (20MG/ML)

injectable Discontinued INJECTION N/A Feb 27, 2008
500MG/25ML (20MG/ML)

injectable Prescription INJECTION AP Nov 26, 2008





23. ZENNOVA

Zennova Pharmaceuticals Chengdu Co Ltd has filed for 2 different strengths of generic version for Irinotecan Hydrochloride. Given below are the details of the strengths of this generic introduced by Zennova.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/2ML (20MG/ML)

injectable Prescription INJECTION AP May 13, 2011
100MG/5ML (20MG/ML)

injectable Prescription INJECTION AP May 13, 2011