Metronidazole Patent Expiration
Metronidazole was first introduced by Pfizer Inc
Metronidazole Patents
Given below is the list of patents protecting Metronidazole, 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 |
|---|---|---|---|---|
| Flagyl Er | US6103262 | Modified-release metronidazole compositions and methods for making and using same |
Aug 15, 2017
(Expired) | Pfizer |
| Likmez | US11541035 | Oral formulations of metronidazole and methods of treating an infection using same | Oct 04, 2039 | Saptalis Pharms |
| Metrogel | US6881726 | Aqueous compositions containing metronidazole |
Feb 21, 2022
(Expired) | Galderma Labs Lp |
| Metrogel | US7348317 | Aqueous compositions containing metronidazole |
Feb 21, 2022
(Expired) | Galderma Labs Lp |
| Metrogel-vaginal | US5536743 | Intravaginal treatment of vaginal infections with buffered metronidazole compositions |
Jul 16, 2013
(Expired) | Bausch |
| Nuvessa | US10238634 | Aqueous-based metronidazole gel formulations | Jun 28, 2032 | Chemo Research Sl |
| Nuvessa | US10596155 | Aqueous-based metronidazole gel formulations | Jun 28, 2032 | Chemo Research Sl |
| Nuvessa | US7893097 | Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water | Feb 19, 2028 | Chemo Research Sl |
| Nuvessa | US8658678 | Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water | Jun 27, 2028 | Chemo Research Sl |
| Nuvessa | US8877792 | Compositions for increasing solubility of azole drug compounds that are poorly soluble in water | Feb 02, 2028 | Chemo Research Sl |
| Nuvessa | US8946276 | High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis | Jun 28, 2032 | Chemo Research Sl |
| Nuvessa | US9198858 | Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations | Jun 28, 2032 | Chemo Research Sl |
| Vandazole | US7456207 | Vaginal pharmaceutical compositions and methods for preparing them | Sep 22, 2024 | Teva Pharms |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Metronidazole's patents.
Latest Legal Activities on Metronidazole's Patents
Given below is the list recent legal activities going on the following patents of Metronidazole.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 23 Dec, 2016 | US7456207 |
| Patent Issue Date Used in PTA Calculation | 25 Nov, 2008 | US7456207 |
| Recordation of Patent Grant Mailed | 25 Nov, 2008 | US7456207 |
| Issue Notification Mailed | 05 Nov, 2008 | US7456207 |
| Dispatch to FDC | 24 Oct, 2008 | US7456207 |
| Application Is Considered Ready for Issue | 17 Oct, 2008 | US7456207 |
| Issue Fee Payment Verified | 09 Oct, 2008 | US7456207 |
| Issue Fee Payment Received | 09 Oct, 2008 | US7456207 |
| Mail Examiner's Amendment | 22 Sep, 2008 | US7456207 |
| Mail Notice of Allowance | 22 Sep, 2008 | US7456207 |
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Metronidazole Generics
Several generic applications have been filed for Metronidazole. The first generic version for Metronidazole was by Teva Pharmaceuticals Usa Inc and was approved on Nov 6, 1984. And the latest generic version is by Encube Ethicals Private Ltd and was approved on Mar 18, 2024.
Given below is the list of companies who have filed for Metronidazole generic.
1. HERITAGE PHARMS INC
Heritage Pharmaceuticals Inc has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Heritage Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Sep 23, 2015 |
| 500MG | tablet | Prescription | ORAL | AB | Sep 23, 2015 |
2. TARO
Taro Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Taro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | gel | Prescription | TOPICAL | AB | Jul 18, 2006 |
| 1% | gel | Prescription | TOPICAL | AB | Mar 14, 2017 |
3. LABS AF
Laboratorios Aplicaciones Farmaceuticas Sa De Cv has filed for 2 different strengths of generic version for Metronidazole. All of these versions come by the name METROMIDOL. Given below are the details of the strengths of this generic introduced by Labs Af.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Discontinued | ORAL | N/A | Oct 24, 1996 |
| 500MG | tablet | Discontinued | ORAL | N/A | Oct 24, 1996 |
4. CADILA PHARMS LTD
Cadila Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Cadila Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Dec 12, 2017 |
| 500MG | tablet | Prescription | ORAL | AB | Dec 12, 2017 |
5. AMNEAL
Amneal Eu Ltd has filed for 1 generic for Metronidazole. This 500mg/100ml version comes by the name METRONIDAZOLE IN PLASTIC CONTAINER. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/100ML | injectable | Prescription | INJECTION | AP | May 24, 2023 |
6. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Strides Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | May 25, 2016 |
| 500MG | tablet | Prescription | ORAL | AB | May 25, 2016 |
7. COSETTE
Cosette Pharmaceuticals Inc has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Cosette.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | gel | Prescription | VAGINAL | AB | Jul 12, 2023 |
| 1% | gel | Prescription | TOPICAL | AB | Jan 23, 2023 |
8. UNICHEM
Unichem Laboratories Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Unichem.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Jan 22, 2014 |
| 250MG | tablet | Prescription | ORAL | AB | Jan 22, 2014 |
9. SOLARIS PHARMA CORP
Solaris Pharma Corp has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Solaris Pharma Corp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | gel | Prescription | VAGINAL | AB | Oct 14, 2021 |
10. SAVAGE LABS
Savage Laboratories Inc Div Altana Inc has filed for 2 different strengths of generic version for Metronidazole. All of these versions come by the name SATRIC. Given below are the details of the strengths of this generic introduced by Savage Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Discontinued | ORAL | N/A | Mar 19, 1985 |
| 500MG | tablet | Discontinued | ORAL | N/A | Jun 8, 1987 |
11. WATSON LABS INC
Watson Laboratories Inc has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Feb 8, 1985 |
12. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 5 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 375MG | capsule | Prescription | ORAL | AB | Jun 23, 2009 |
| 750MG | tablet, extended release | Discontinued | ORAL | N/A | May 5, 2010 |
| 250MG | tablet | Prescription | ORAL | AB | Jun 20, 2017 |
| 500MG | tablet | Prescription | ORAL | AB | Jun 20, 2017 |
| 1% | gel | Prescription | TOPICAL | AB | Sep 3, 2021 |
13. ENCUBE
Encube Ethicals Private Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Encube.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | gel | Prescription | VAGINAL | AB | Jun 16, 2023 |
| 1.3% | gel | Prescription | VAGINAL | AB | Mar 18, 2024 |
14. TEVA PHARMS USA
Teva Pharmaceuticals Usa Inc has filed for 1 generic for Metronidazole. 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 |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Nov 6, 1984 |
15. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 1 generic for Metronidazole. This 500mg/100ml version comes by the name METRONIDAZOLE IN PLASTIC CONTAINER. 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/100ML | injectable | Prescription | INJECTION | AP | Aug 3, 2020 |
16. WATSON LABS
Watson Laboratories Inc has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Watson Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Dec 20, 1984 |
| 500MG/100ML | injectable | Discontinued | INJECTION | N/A | Apr 1, 1986 |
17. HALSEY
Halsey Drug Co Inc has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Halsey.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Discontinued | ORAL | N/A | Apr 2, 1985 |
| 500MG | tablet | Discontinued | ORAL | N/A | Feb 27, 1986 |
18. LUPIN LTD
Lupin Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Lupin Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Sep 12, 2017 |
| 500MG | tablet | Prescription | ORAL | AB | Sep 12, 2017 |
19. SUPERPHARM
Superpharm Corp has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Superpharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Discontinued | ORAL | N/A | Dec 11, 1984 |
| 500MG | tablet | Discontinued | ORAL | N/A | Dec 11, 1984 |
20. PLIVA
Pliva Inc has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Pliva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Dec 6, 1984 |
21. INTL MEDICATION
International Medication Systems Ltd has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Intl Medication.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/100ML | injectable | Discontinued | INJECTION | N/A | May 8, 1985 |
22. MUTUAL PHARM
Mutual Pharmaceutical Co Inc has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Mutual Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Jul 16, 1986 |
23. INNOGENIX
Innogenix Llc has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Innogenix.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG | tablet | Prescription | ORAL | AB | Jul 16, 1986 |
| 500MG | tablet | Prescription | ORAL | AB | Jul 16, 1986 |
24. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Metronidazole. 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 |
|---|---|---|---|---|---|
| 375MG | capsule | Prescription | ORAL | AB | Jan 29, 2004 |
| 1% | gel | Discontinued | TOPICAL | N/A | Jul 22, 2011 |
25. ALEMBIC PHARMS LTD
Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Alembic Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Mar 13, 2009 |
| 250MG | tablet | Prescription | ORAL | AB | Mar 13, 2009 |
26. ABLE
Able Laboratories Inc has filed for 4 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Able.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 750MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 25, 2003 |
| 500MG | tablet | Discontinued | ORAL | N/A | Jun 27, 2003 |
| 250MG | tablet | Discontinued | ORAL | N/A | Jun 27, 2003 |
| 375MG | capsule | Discontinued | ORAL | N/A | Nov 13, 2003 |
27. CADILA
Cadila Healthcare Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Cadila.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Prescription | ORAL | AB | Nov 16, 2016 |
| 250MG | tablet | Prescription | ORAL | AB | Nov 16, 2016 |
28. ABRAXIS PHARM
Abraxis Pharmaceutical Products has filed for 1 generic for Metronidazole. 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 |
|---|---|---|---|---|---|
| 500MG/100ML | injectable | Discontinued | INJECTION | N/A | Dec 3, 1984 |
29. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | gel | Prescription | VAGINAL | AB | Jan 27, 2022 |
30. FOUGERA PHARMS
Fougera Pharmaceuticals Inc has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Fougera Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | gel | Prescription | TOPICAL | AB | Jun 6, 2006 |
31. FLAMINGO PHARMS
Flamingo Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Flamingo Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG | tablet | Discontinued | ORAL | N/A | May 16, 2016 |
| 250MG | tablet | Discontinued | ORAL | N/A | May 16, 2016 |
32. RISING
Rising Pharma Holding Inc has filed for 1 generic for Metronidazole. This 500mg/100ml version comes by the name METRONIDAZOLE IN PLASTIC CONTAINER. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/100ML | injectable | Discontinued | INJECTION | N/A | May 9, 2017 |
33. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Metronidazole. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG
(reference standard) | tablet | Prescription | ORAL | AB | May 29, 2015 |
| 250MG | tablet | Prescription | ORAL | AB | May 29, 2015 |
34. INFORLIFE
Inforlife Sa has filed for 1 generic for Metronidazole. This 500mg/100ml version comes by the name METRONIDAZOLE IN PLASTIC CONTAINER. Given below are the details of the strengths of this generic introduced by Inforlife.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/100ML | injectable | Prescription | INJECTION | AP | Feb 25, 2019 |
35. BAXTER HLTHCARE CORP
Baxter Healthcare Corp has filed for 1 generic for Metronidazole. This 500mg/100ml version comes by the name METRONIDAZOLE IN PLASTIC CONTAINER. Given below are the details of the strengths of this generic introduced by Baxter Hlthcare Corp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 500MG/100ML | injectable | Prescription | INJECTION | AP | Mar 31, 2008 |
36. ZYDUS LIFESCIENCES
Zydus Lifesciences Ltd has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | cream | Prescription | TOPICAL | AB | Apr 21, 2023 |
37. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Metronidazole. Given below are the details of the strengths of this generic introduced by Padagis Israel.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75% | gel | Prescription | VAGINAL | AB | Jul 2, 2019 |