Diclofenac Sodium Patent Expiration
Diclofenac Sodium is Used for treating or controlling ocular inflammation in the affected eye. It was first introduced by Novartis Pharmaceuticals Corp
Diclofenac Sodium Patents
Given below is the list of patents protecting Diclofenac Sodium, 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 |
|---|---|---|---|---|
| Diclofenac Sodium | US5603929 | Preserved ophthalmic drug compositions containing polymeric quaternary ammonium compounds |
Nov 16, 2014
(Expired) | Falcon Pharms |
| Diclofenac Sodium | US5653972 | Preserved ophthalmic drug compositions containing polymeric quaternary ammonium compounds |
Nov 16, 2014
(Expired) | Falcon Pharms |
| Dyloject | US6407079 | Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation |
Jun 18, 2019
(Expired) | Javelin Pharms Inc |
| Dyloject | US8946292 | Formulations of low dose diclofenac and beta-cyclodextrin | Mar 22, 2027 | Javelin Pharms Inc |
| Pennsaid | US8217078 | Treatment of pain with topical diclofenac | Jul 10, 2029 | Horizon |
| Pennsaid | US8217078 | Treatment of pain with topical diclofenac | Jul 10, 2029 | Nuvo Pharms Inc |
| Pennsaid | US8252838 | Diclofenac topical formulation | Apr 21, 2028 | Horizon |
| Pennsaid | US8546450 | Treatment of pain with topical diclofenac compounds | Aug 09, 2030 | Horizon |
| Pennsaid | US8546450 | Treatment of pain with topical diclofenac compounds | Aug 09, 2030 | Nuvo Pharms Inc |
| Pennsaid | US8563613 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US8618164 | Treatment of pain with topical diclofenac compounds | Jul 10, 2029 | Horizon |
| Pennsaid | US8618164 | Treatment of pain with topical diclofenac compounds | Jul 10, 2029 | Nuvo Pharms Inc |
| Pennsaid | US8741956 | Treatment of pain with topical diclofenac | Jul 10, 2029 | Horizon |
| Pennsaid | US8741956 | Treatment of pain with topical diclofenac | Jul 10, 2029 | Nuvo Pharms Inc |
| Pennsaid | US8871809 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9066913 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9101591 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9132110 | Treatment of pain with topical diclofenac | Oct 17, 2027 | Horizon |
| Pennsaid | US9168304 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9168305 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9220784 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9339551 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9339552 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Pennsaid | US9370501 | Treatment of pain with topical diclofenac | Jul 10, 2029 | Horizon |
| Pennsaid | US9375412 | Treatment of pain with topical diclofenac | Jul 10, 2029 | Horizon |
| Pennsaid | US9415029 | Treatment of pain with topical diclofenac | Jul 10, 2029 | Horizon |
| Pennsaid | US9539335 | Diclofenac topical formulation | Oct 17, 2027 | Horizon |
| Solaraze | US5639738 | Treatment of basal cell carcinoma and actinic keratosis employing hyaluronic acid and NSAIDs |
Jun 17, 2014
(Expired) | Fougera Pharms |
| Solaraze | US5792753 | Compositions comprising hyaluronic acid and prostaglandin-synthesis-inhibiting drugs |
Aug 11, 2015
(Expired) | Fougera Pharms |
| Solaraze | US5852002 | Treatment of conditions and disease |
Jun 17, 2014
(Expired) | Fougera Pharms |
| Solaraze | US5914322 | Treatment of disease and conditions |
Aug 11, 2015
(Expired) | Fougera Pharms |
| Solaraze | US5929048 | Treatment of conditions and disease |
Jun 17, 2014
(Expired) | Fougera Pharms |
| Solaraze | US5985850 | Compositions comprising hyaluronic acid and drugs |
Aug 11, 2015
(Expired) | Fougera Pharms |
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Diclofenac Sodium Generics
Several generic applications have been filed for Diclofenac Sodium. The first generic version for Diclofenac Sodium was by Roxane Laboratories Inc and was approved on Jun 29, 1995. And the latest generic version is by Rubicon Research Private Ltd and was approved on May 11, 2023.
Given below is the list of companies who have filed for Diclofenac Sodium generic.
1. TARO
Taro Pharmaceuticals Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Taro.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.5%
(reference standard) | solution | Prescription | TOPICAL | AT | Nov 26, 2014 |
| 3%
(reference standard) | gel | Prescription | TOPICAL | AB | Apr 28, 2016 |
| 2% | solution | Prescription | TOPICAL | AB | Sep 29, 2022 |
2. AMNEAL
Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3% | gel | Prescription | TOPICAL | AB | Oct 28, 2013 |
| 2% | solution | Prescription | TOPICAL | AB | Aug 18, 2022 |
3. AUROLIFE PHARMA LLC
Aurolife Pharma Llc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Aurolife Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1% | gel | Over the counter | TOPICAL | N/A | May 6, 2019 |
| 2% | solution | Prescription | TOPICAL | AB | Feb 3, 2023 |
4. MICRO LABS
Micro Labs Ltd has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Micro Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet, delayed release | Discontinued | ORAL | N/A | Feb 26, 1999 |
| 75MG | tablet, delayed release | Discontinued | ORAL | N/A | Feb 26, 1999 |
5. TEVA
Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Teva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MG | tablet, delayed release | Discontinued | ORAL | N/A | Aug 15, 1996 |
| 50MG | tablet, delayed release | Discontinued | ORAL | N/A | Mar 30, 1999 |
6. UNIQUE
Unique Pharmaceutical Laboratories A Div Of Jb Chemicals And Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Unique.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MG
(reference standard) | tablet, delayed release | Prescription | ORAL | AB | Jun 8, 2007 |
| 25MG
(reference standard) | tablet, delayed release | Prescription | ORAL | AB | Dec 1, 2010 |
| 50MG
(reference standard) | tablet, delayed release | Prescription | ORAL | AB | Dec 1, 2010 |
7. AMNEAL PHARMS
Amneal Pharmaceuticals has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Amneal Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1% | gel | Over the counter | TOPICAL | N/A | Mar 18, 2016 |
| 1.5% | solution | Prescription | TOPICAL | AT | Sep 2, 2016 |
8. APOTEX
Apotex Inc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.5% | solution | Discontinued | TOPICAL | N/A | May 27, 2014 |
| 2% | solution | Prescription | TOPICAL | AB | May 6, 2022 |
9. PAI HOLDINGS PHARM
Pai Holdings Llc Dba Pharmaceutical Associates Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Pai Holdings Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.5% | solution | Discontinued | TOPICAL | N/A | Jul 8, 2015 |
10. WATSON LABS INC
Watson Laboratories Inc has filed for 1 generic for Diclofenac Sodium. 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 |
|---|---|---|---|---|---|
| 1.5% | solution | Prescription | TOPICAL | AT | Nov 24, 2014 |
11. NOVEL LABS INC
Novel Laboratories Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.5% | solution | Prescription | TOPICAL | AT | Dec 9, 2015 |
12. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3% | gel | Prescription | TOPICAL | AB | Jul 27, 2022 |
| 2% | solution | Prescription | TOPICAL | AB | Nov 29, 2022 |
13. ENCUBE
Encube Ethicals Private Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Encube.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1% | gel | Over the counter | TOPICAL | N/A | Jan 27, 2020 |
14. CIPLA
Cipla Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Cipla.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1% | gel | Prescription | TOPICAL | N/A | Aug 3, 2018 |
15. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1% | gel | Discontinued | TOPICAL | N/A | Nov 21, 2018 |
16. LUPIN LTD
Lupin Ltd has filed for 1 generic for Diclofenac Sodium. 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 |
|---|---|---|---|---|---|
| 1.5% | solution | Prescription | TOPICAL | AT | Aug 20, 2015 |
17. ZYDUS LIFESCIENCES
Zydus Lifesciences Ltd has filed for 1 generic for Diclofenac Sodium. 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 |
|---|---|---|---|---|---|
| 1.5% | solution | Prescription | TOPICAL | AT | Apr 17, 2018 |
18. PLIVA
Pliva Inc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Pliva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet, delayed release | Discontinued | ORAL | N/A | Jul 29, 1999 |
| 75MG | tablet, delayed release | Discontinued | ORAL | N/A | Jul 29, 1999 |
19. VPNA
Valeant Pharmaceuticals North America has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Vpna.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | tablet, extended release | Prescription | ORAL | AB | Feb 11, 2000 |
20. PERRIGO PHARMA INTL
Perrigo Pharma International Dac has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Perrigo Pharma Intl.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1% | gel | Over the counter | TOPICAL | N/A | May 16, 2019 |
21. LUPIN PHARMS
Lupin Pharmaceuticals Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Lupin Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2%
(reference standard) | solution | Prescription | TOPICAL | AB | Sep 20, 2022 |
22. SAPTALIS PHARMS
Saptalis Pharmaceuticals Llc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Saptalis Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.1% | solution/drops | Discontinued | OPHTHALMIC | N/A | Apr 17, 2008 |
23. ACTAVIS ELIZABETH
Actavis Elizabeth Llc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MG | tablet, delayed release | Prescription | ORAL | AB | Mar 26, 1996 |
| 50MG | tablet, delayed release | Prescription | ORAL | AB | Mar 26, 1996 |
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Jan 7, 2002 |
24. RICONPHARMA LLC
Riconpharma Llc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Riconpharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | tablet, extended release | Prescription | ORAL | AB | Sep 23, 2022 |
25. ACTAVIS LABS UT INC
Actavis Laboratories Ut Inc Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Actavis Labs Ut Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2% | solution | Prescription | TOPICAL | AT | May 15, 2017 |
26. TWI PHARMS
Twi Pharmaceuticals Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Twi Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.5% | solution | Discontinued | TOPICAL | N/A | Nov 24, 2014 |
27. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Diclofenac Sodium. 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 |
|---|---|---|---|---|---|
| 25MG | tablet, delayed release | Discontinued | ORAL | N/A | Sep 28, 1995 |
| 50MG | tablet, delayed release | Discontinued | ORAL | N/A | Sep 28, 1995 |
| 75MG | tablet, delayed release | Discontinued | ORAL | N/A | Nov 30, 1995 |
28. AUROBINDO PHARMA USA
Aurobindo Pharma Usa Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Dec 13, 2001 |
| 50MG | tablet, delayed release | Discontinued | ORAL | N/A | Feb 12, 2002 |
| 75MG | tablet, delayed release | Discontinued | ORAL | N/A | Feb 12, 2002 |
29. ROXANE
Roxane Laboratories Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Roxane.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet, delayed release | Discontinued | ORAL | N/A | Jun 29, 1995 |
| 75MG | tablet, delayed release | Discontinued | ORAL | N/A | Jun 29, 1995 |
| 25MG | tablet, delayed release | Discontinued | ORAL | N/A | Jun 29, 1995 |
30. SANDOZ
Sandoz Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.1% | solution/drops | Prescription | OPHTHALMIC | AT | Feb 6, 2008 |
31. ALTAIRE PHARMS INC
Altaire Pharmaceuticals Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Altaire Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.1% | solution/drops | Prescription | OPHTHALMIC | AT | Nov 16, 2015 |
32. DEXCEL LTD
Dexcel Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Dexcel Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 100MG
(reference standard) | tablet, extended release | Prescription | ORAL | AB | Nov 6, 2002 |
33. BAUSCH AND LOMB
Bausch And Lomb Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Bausch And Lomb.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.1%
(reference standard) | solution/drops | Prescription | OPHTHALMIC | AT | Dec 28, 2007 |
34. RUBICON
Rubicon Research Private Ltd has filed for 4 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Rubicon.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.1% | solution/drops | Prescription | OPHTHALMIC | AT | Nov 13, 2008 |
| 25MG | tablet, delayed release | Prescription | ORAL | AB | May 11, 2023 |
| 50MG | tablet, delayed release | Prescription | ORAL | AB | May 11, 2023 |
| 75MG | tablet, delayed release | Prescription | ORAL | AB | May 11, 2023 |
35. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 1 generic for Diclofenac Sodium. 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 |
|---|---|---|---|---|---|
| 3% | gel | Prescription | TOPICAL | AB | Sep 13, 2016 |
36. RISING
Rising Pharma Holding Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.1% | solution/drops | Prescription | OPHTHALMIC | AT | Dec 28, 2007 |
| 1.5% | solution | Discontinued | TOPICAL | N/A | Aug 7, 2017 |
| 37.5MG/ML (37.5MG/ML) | solution | Discontinued | INTRAVENOUS | N/A | Jun 18, 2019 |
37. ACTAVIS MID ATLANTIC
Actavis Mid Atlantic Llc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Actavis Mid Atlantic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 3% | gel | Prescription | TOPICAL | AB | Dec 2, 2015 |
38. TEVA PHARMS
Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Teva Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MG | tablet, delayed release | Discontinued | ORAL | N/A | Jun 25, 1997 |
| 25MG | tablet, delayed release | Discontinued | ORAL | N/A | Jun 25, 1997 |
| 50MG | tablet, delayed release | Discontinued | ORAL | N/A | Jun 25, 1997 |
39. EPIC PHARMA LLC
Epic Pharma Llc has filed for 1 generic for Diclofenac Sodium. 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 |
|---|---|---|---|---|---|
| 1.5% | solution | Prescription | TOPICAL | AT | Jan 28, 2021 |
40. CARLSBAD
Carlsbad Technology Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Carlsbad.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MG | tablet, delayed release | Prescription | ORAL | AB | Nov 13, 1998 |
| 50MG | tablet, delayed release | Prescription | ORAL | AB | Nov 13, 1998 |
| 25MG | tablet, delayed release | Prescription | ORAL | AB | Nov 13, 1998 |
41. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Diclofenac Sodium. 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 |
|---|---|---|---|---|---|
| 3% | gel | Prescription | TOPICAL | AB | Jul 27, 2018 |