Fluorouracil Patent Expiration
Fluorouracil was first introduced by Spectrum Pharmaceuticals Inc
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 |
|---|---|---|---|---|
| Carac | US6670335 | Fluorouracil-containing formulation |
Jun 02, 2021
(Expired) | Valeant Pharms North |
| Tolak | US7169401 | Topical skin care composition containing refined peanut oil |
Jul 18, 2023
(Expired) | Hill Dermaceuticals |
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Fluorouracil Generics
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 Encube Ethicals Private Ltd and was approved on Nov 2, 2023.
Given below is the list of companies who have filed for Fluorouracil generic.
1. 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 |
2. 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 |
3. EXTROVIS
Extrovis Ag has filed for 1 generic for Fluorouracil. Given below are the details of the strengths of this generic introduced by Extrovis.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5% | cream | Discontinued | TOPICAL | N/A | Apr 20, 2015 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |
13. 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 |
14. 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 |
15. 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 |
16. 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 |
17. 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 |
18. 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 |
19. 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 |
20. 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 |
21. 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 |
22. 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 |