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Fluorouracil Patent Expiration

Fluorouracil was first introduced by Spectrum Pharmaceuticals Inc in its drug Fluorouracil on Approved Prior to Jan 1, 1982. Other drugs containing Fluorouracil are Tolak, Carac, Efudex, Adrucil, Fluoroplex. 28 different companies have introduced drugs containing Fluorouracil.


Fluorouracil Patents

Given below is the list of patents protecting Fluorouracil, 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
Tolak US7169401 Topical skin care composition containing refined peanut oil Jul 18, 2023

(Expired)

 Hill Dermaceuticals
Carac US6670335 Fluorouracil-containing formulation Jun 02, 2021

(Expired)

 Valeant Pharms North



Fluorouracil's Family Patents

Family Patents

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Fluorouracil Generic API Manufacturers

Several generic applications have been filed for Fluorouracil. The first generic version for Fluorouracil was by Spectrum Pharmaceuticals Inc and was approved on Oct 13, 1982. And the latest generic version is by Kindos Pharmaceuticals Co Ltd and was approved on Sep 24, 2024.

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


1. ABIC

Abic Ltd has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Abic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Mar 4, 1986


Manufacturing Plant Locations
New

Abic's manufacturing plants are situated in 2 countries - Canada, Israel. Given below are the details of these plant locations as well as the firm names of Abic as present at those locations.

Country City Firm Name
Canada
Montreal Abich Inc
Israel
Netanya Abic Ltd.





2. ABRAXIS PHARM

Abraxis Pharmaceutical Products has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Abraxis Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Mar 12, 1987





3. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 5 different strengths of generic version for Fluorouracil. 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
2.5GM/50ML (50MG/ML)

(reference standard)

injectable Prescription INJECTION AP Apr 26, 2007
1GM/20ML (50MG/ML)

(reference standard)

injectable Prescription INJECTION AP Apr 26, 2007
500MG/10ML (50MG/ML)

(reference standard)

injectable Prescription INJECTION AP Apr 26, 2007
5GM/100ML (50MG/ML)

(reference standard)

injectable Prescription INJECTION AP Apr 26, 2007
5%

cream Prescription TOPICAL AB Oct 7, 2021





4. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Fluorouracil. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5GM/50ML (50MG/ML)

injectable Prescription INJECTION AP Mar 3, 2023
5GM/100ML (50MG/ML)

injectable Prescription INJECTION AP Oct 18, 2023


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





5. BEDFORD

Bedford Laboratories Div Ben Venue Laboratories Inc has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Bedford.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Jan 26, 1988


Manufacturing Plant Locations
New

Bedford'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 Bedford as present at those locations.

Country City Firm Name
United States
Shelbyville Bedford Cheese Store Inc
Curryville Bedford Farm Bureau Cooperative
Bedford Bedford Research Foundation, Inc.





6. DR REDDYS LABS SA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Prescription TOPICAL AB Apr 11, 2008





7. EBEWE PHARMA

Ebewe Pharma Ges Mbh Nfg Kg has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Ebewe Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG/10ML (50MG/ML)

injectable Discontinued INJECTION N/A Aug 11, 2008





8. ENCUBE

Encube Ethicals Private Ltd has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

solution Prescription TOPICAL AT Nov 2, 2023


Manufacturing Plant Locations
New

Encube'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 Encube as present at those locations.

Country City Firm Name
India
Ponda Encube Ethicals Pvt. Ltd.
Andheri East, Mumbai Encube Ethicals Private Ltd





9. EUGIA PHARMA SPECLTS

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
5GM/100ML (50MG/ML)

injectable Prescription INJECTION AP Jul 17, 2012
1GM/20ML (50MG/ML)

injectable Prescription INJECTION AP Jul 17, 2012
2.5GM/50ML (50MG/ML)

injectable Prescription INJECTION AP Jul 17, 2012
500MG/10ML (50MG/ML)

injectable Prescription INJECTION AP Jul 17, 2012





10. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 5 different strengths of generic version for Fluorouracil. 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
5GM/100ML (50MG/ML)

injectable Prescription INJECTION AP Sep 30, 1998
2.5GM/50ML (50MG/ML)

injectable Prescription INJECTION AP Sep 30, 1998
500MG/10ML (50MG/ML)

injectable Prescription INJECTION AP Sep 30, 1998
1GM/20ML (50MG/ML)

injectable Prescription INJECTION AP Sep 30, 1998
50MG/ML

injectable Discontinued INJECTION N/A Nov 15, 2000


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





11. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 4 different strengths of generic version for Fluorouracil. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG/10ML (50MG/ML)

injectable Prescription INJECTION AP Oct 27, 2017
1GM/20ML (50MG/ML)

injectable Prescription INJECTION AP Oct 27, 2017
2.5GM/50ML (50MG/ML)

injectable Prescription INJECTION AP Dec 26, 2017
5GM/100ML (50MG/ML)

injectable Prescription INJECTION AP Dec 26, 2017





12. KINDOS

Kindos Pharmaceuticals Co Ltd has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Kindos.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5GM/50ML (50MG/ML)

injectable Prescription INJECTION AP Sep 24, 2024


Manufacturing Plant Locations
New

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

Country City Firm Name
China
Chengdu Kindos Pharmaceuticals Co., Ltd.





13. MARCHAR

Marchar Laboratories Inc Ltd has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Marchar.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Jan 18, 1983





14. NOVAST LABS

Novast Laboratories Ltd has filed for 4 different strengths of generic version for Fluorouracil. 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
5GM/100ML (50MG/ML)

injectable Discontinued INJECTION N/A Dec 11, 2019
2.5GM/50ML (50MG/ML)

injectable Discontinued INJECTION N/A Dec 11, 2019
500MG/10ML (50MG/ML)

injectable Discontinued INJECTION N/A Dec 12, 2019
1GM/20ML (50MG/ML)

injectable Discontinued INJECTION N/A Dec 12, 2019





15. PHARMACIA AND UPJOHN

Pharmacia And Upjohn Co has filed for 1 generic for Fluorouracil. This 50mg/ml version comes by the name ADRUCIL. Given below are the details of the strengths of this generic introduced by Pharmacia And Upjohn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Jun 28, 1991





16. RISING

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5%

cream Discontinued TOPICAL N/A Apr 20, 2015


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





17. SAGENT PHARMS INC

Sagent Pharmaceuticals Inc has filed for 4 different strengths of generic version for Fluorouracil. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5GM/50ML (50MG/ML)

injectable Prescription INJECTION AP Feb 17, 2016
5GM/100ML (50MG/ML)

injectable Prescription INJECTION AP Feb 17, 2016
1GM/20ML (50MG/ML)

injectable Prescription INJECTION AP May 11, 2017
500MG/10ML (50MG/ML)

injectable Prescription INJECTION AP May 11, 2017





18. SANDOZ

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5GM/50ML (50MG/ML)

injectable Discontinued INJECTION N/A May 2, 2011
5GM/100ML (50MG/ML)

injectable Discontinued INJECTION N/A May 2, 2011


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





19. SMITH AND NEPHEW

Smith And Nephew Solopak Div Smith And Nephew has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Smith And Nephew.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Mar 26, 1987


Manufacturing Plant Locations
New

Smith And Nephew'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 Smith And Nephew as present at those locations.

Country City Firm Name
United States
Goodlettsville Smith and Nephew





20. SPECTRUM PHARMS

Spectrum Pharmaceuticals Inc has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Spectrum Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Oct 13, 1982





21. TARO

Taro Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Fluorouracil. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5%

cream Prescription TOPICAL AB Mar 5, 2010
2%

solution Prescription TOPICAL AT Nov 5, 2003


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Honolulu Taro Delight, LLC
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





22. TEVA PARENTERAL

Teva Parenteral Medicines Inc has filed for 1 generic for Fluorouracil. This 50mg/ml version comes by the name ADRUCIL. Given below are the details of the strengths of this generic introduced by Teva Parenteral.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/ML

injectable Discontinued INJECTION N/A Oct 18, 1991


Manufacturing Plant Locations
New

Teva Parenteral'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 Teva Parenteral as present at those locations.

Country City Firm Name
United States
Irvine Teva Parenteral Medicines, Inc.





23. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Fluorouracil. 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
500MG/10ML (50MG/ML)

injectable Discontinued INJECTION N/A Jan 27, 2000
2.5GM/50ML (50MG/ML)

injectable Discontinued INJECTION N/A Feb 25, 2000
5GM/100ML (50MG/ML)

injectable Discontinued INJECTION N/A Feb 25, 2000