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Naproxen Sodium Patent Expiration

Naproxen Sodium was first introduced by Atnahs Pharma Us Ltd in its drug Anaprox on Approved Prior to Jan 1, 1982. Other drugs containing Naproxen Sodium are Naprelan, Aleve, Anaprox Ds, Naproxen Sodium. 37 different companies have introduced drugs containing Naproxen Sodium.


Naproxen Sodium Patents

Given below is the list of patents protecting Naproxen 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
Naproxen Sodium US10022344 Liquid dosage forms of sodium naproxen Mar 03, 2026 Bionpharma
Naproxen Sodium US10028925 Liquid dosage forms of sodium naproxen Mar 03, 2026 Bionpharma
Naproxen Sodium US11090280 Liquid dosage forms of sodium naproxen Mar 03, 2026 Bionpharma
Naproxen Sodium US9693978 Solvent system for enhancing the solubility of pharmaceutical agents Mar 03, 2026 Bionpharma
Naproxen Sodium US9693979 Liquid dosage forms of sodium naproxen Mar 03, 2026 Bionpharma
Naprelan US5637320 Controlled absorption naproxen formulation for once-daily administration Jun 10, 2014

(Expired)

 Twi 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 Naproxen Sodium's patents.

Given below is the list recent legal activities going on the following patents of Naproxen Sodium.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 12 Jan, 2022 US10028925
Payment of Maintenance Fee, 4th Year, Large Entity 05 Jan, 2022 US10022344
Patent Issue Date Used in PTA Calculation
Critical
 17 Aug, 2021 US11090280
Recordation of Patent Grant Mailed
Critical
 17 Aug, 2021 US11090280
Email Notification
Critical
 29 Jul, 2021 US11090280
Issue Notification Mailed
Critical
 28 Jul, 2021 US11090280
Application Is Considered Ready for Issue
Critical
 22 Jul, 2021 US11090280
Dispatch to FDC 22 Jul, 2021 US11090280
Response to Reasons for Allowance 13 Jul, 2021 US11090280
Issue Fee Payment Verified
Critical
 13 Jul, 2021 US11090280


Naproxen Sodium's Family Patents

Family Patents

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Naproxen Sodium Generic API Manufacturers

Several generic applications have been filed for Naproxen Sodium. The first generic version for Naproxen Sodium was by Hamilton Pharmaceuticals Ltd and was approved on Aug 31, 1993. And the latest generic version is by Patheon Softgels Bv and was approved on Jan 10, 2023.

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


1. ABLE

Able Laboratories Inc has filed for 2 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Able.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE

tablet Discontinued ORAL N/A Aug 22, 2003
EQ 250MG BASE

tablet Discontinued ORAL N/A Aug 22, 2003


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Mayaguez Able Sales Company
Roseville AbleNet, Inc.
Raleigh Ablexan Corporation
Los Angeles ABLE INC
Catano Able Sales Company, Inc.
Los Angeles Able Freight Services LLC
Cincinnati Ablecare Medical Inc
Sparks Able Groupe Inc
Malaysia
Telok Panglima Garang Able Dairies





2. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 3 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE

tablet, extended release Prescription ORAL AB Aug 27, 2002
EQ 375MG BASE

tablet, extended release Prescription ORAL AB Apr 23, 2003
EQ 750MG BASE

tablet, extended release Prescription ORAL AB Aug 11, 2016





3. AMNEAL PHARMS NY

Amneal Pharmaceuticals Ny Llc has filed for 3 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Amneal Pharms Ny.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE

tablet Discontinued ORAL N/A Apr 25, 2007
EQ 250MG BASE

tablet Discontinued ORAL N/A Apr 25, 2007
220MG

tablet Over the counter ORAL N/A Dec 16, 2008





4. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Naproxen Sodium. 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
EQ 250MG BASE

tablet Prescription ORAL AB Oct 31, 2011
EQ 500MG BASE

tablet Prescription ORAL AB Oct 31, 2011
220MG

tablet Over the counter ORAL N/A Mar 18, 2016


Manufacturing Plant Locations
New

Aurobindo Pharma 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 Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





5. CATALENT

Catalent Pharma Solutions Llc has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Catalent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MG BASE

capsule Over the counter ORAL N/A Jan 4, 2019


Manufacturing Plant Locations
New

Catalent's manufacturing plants are situated in 8 countries - Italy, Argentina, Australia, Belgium, United States, France, Germany, United Kingdom. Given below are the details of these plant locations as well as the firm names of Catalent as present at those locations.

Country City Firm Name
Italy
Anagni Catalent Anagni SRL
Aprilia Catalent Italy S.p.A.
Argentina
Buenos Aires Catalent Argentina S.A.I.C.
Australia
Braeside Catalent Australia Pty Ltd
Belgium
Brussels Catalent Belgium SA
United States
Baltimore Catalent Maryland, Inc.
Bloomington Catalent Indiana, LLC
Malvern Catalent Micron Technologies, Inc.
Greenville Catalent Greenville Inc
Harmans Catalent Maryland Inc
Kansas City Catalent CTS, LLC
Chelsea Catalent Massachusetts, LLC
France
Beinheim Catalent France Beinheim SA
Germany
Eberbach Catalent Germany Eberbach GmbH
Schorndorf Catalent Germany Schorndorf GmbH
United Kingdom
Dartford Catalent Micron Technologies, Limited





6. CONTRACT PHARMACAL

Contract Pharmacal Corp has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Contract Pharmacal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Discontinued ORAL N/A Feb 27, 1997


Manufacturing Plant Locations
New

Contract Pharmacal'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 Contract Pharmacal as present at those locations.

Country City Firm Name
United States
Hauppauge Contract Pharmacal Corporation





7. DR REDDYS LABS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Over the counter ORAL N/A Jul 28, 1998





8. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE

tablet Prescription ORAL AB Jul 26, 2007
EQ 500MG BASE

tablet Prescription ORAL AB Jul 26, 2007





9. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Naproxen 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
EQ 500MG BASE

tablet Prescription ORAL AB Apr 27, 2007
EQ 250MG BASE

tablet Prescription ORAL AB Apr 27, 2007





10. GRANULES INDIA

Granules India Ltd has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Granules India.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Over the counter ORAL N/A Sep 20, 2011


Manufacturing Plant Locations
New

Granules India'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 Granules India as present at those locations.

Country City Firm Name
India
Visakhapatnam Granules India Limited
Parawada Mandal Granules India Limited
Medchal-Malkhajgiri District Granules India Limited
Sangareddy District Granules India Limited
Secunderabad Granules India Limited





11. HAMILTON PHARMS

Hamilton Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Hamilton Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE

tablet Discontinued ORAL N/A Aug 31, 1993
EQ 500MG BASE

tablet Discontinued ORAL N/A Aug 31, 1993





12. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Over the counter ORAL N/A Oct 28, 2022





13. HIKMA

Hikma Pharmaceuticals has filed for 2 different strengths of generic version for Naproxen 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
EQ 500MG BASE

tablet Discontinued ORAL N/A May 14, 1996
EQ 250MG BASE

tablet Discontinued ORAL N/A Feb 18, 1998


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
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





14. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE

tablet Discontinued ORAL N/A Mar 14, 1995
EQ 500MG BASE

tablet Discontinued ORAL N/A Mar 14, 1995





15. LNK INTL INC

Lnk International Inc has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Lnk Intl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Over the counter ORAL N/A Jan 23, 2017





16. MARKSANS PHARMA

Marksans Pharma Ltd has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Marksans Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Over the counter ORAL N/A Mar 16, 2011


Manufacturing Plant Locations
New

Marksans Pharma'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 Marksans Pharma as present at those locations.

Country City Firm Name
United States
Commack Marksans Pharmaceuticals Ltd
India
Verna Marksans Pharma Limited





17. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE

tablet Discontinued ORAL N/A Aug 31, 1994
EQ 250MG BASE

tablet Discontinued ORAL N/A Aug 31, 1994





18. NOVELGENIX THERAPS

Novelgenix Therapeutics Pvt Ltd has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Novelgenix Theraps.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Discontinued ORAL N/A Nov 16, 2018





19. PATHEON SOFTGELS

Patheon Softgels Bv has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Patheon Softgels.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MG BASE

capsule Over the counter ORAL N/A Jan 10, 2023


Manufacturing Plant Locations
New

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

Country City Firm Name
Netherlands
Tilburg Patheon Softgels B.V.
United States
High Point Patheon Softgels Inc.
Greensboro Patheon Softgels Inc





20. PERRIGO

L Perrigo Co has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Perrigo.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Over the counter ORAL N/A Jan 13, 1997


Manufacturing Plant Locations
New

Perrigo'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 Perrigo as present at those locations.

Country City Firm Name
United States
Allegan Perrigo Company PLC-Allegan Logistics Center
Bronx Perrigo New York, Inc.
West Palm Beach Perrigo Florida, Inc
Eau Claire Perrigo Wisconsin, LLC
Martin Perrigo Company PLC
India
Thane Perrigo Laboratories India Pvt Ltd





21. PLD ACQUISITIONS LLC

Pld Acquisitions Llc has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Pld Acquisitions Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Discontinued ORAL N/A Jan 13, 1997


Manufacturing Plant Locations
New

Pld Acquisitions Llc'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 Pld Acquisitions Llc as present at those locations.

Country City Firm Name
United States
Doral PLD Acquisitions LLC





22. PLIVA

Pliva Inc has filed for 2 different strengths of generic version for Naproxen 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
EQ 250MG BASE

tablet Discontinued ORAL N/A Jun 20, 1996
EQ 500MG BASE

tablet Discontinued ORAL N/A Jun 20, 1996


Manufacturing Plant Locations
New

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

Country City Firm Name
Croatia
Brdovec Pliva Hrvatska d.o.o.
Zagreb PLIVA Hrvatska d.o.o.
United States
East Hanover Pliva, Inc.
Czech Republic
Brno PLIVA-Lachema a.s.





23. PURACAP PHARM LLC

Puracap Pharmaceutical Llc has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Puracap Pharm Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MG BASE

capsule Over the counter ORAL N/A Mar 15, 2018





24. PUREPAC PHARM

Purepac Pharmaceutical Co has filed for 2 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Purepac Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE

tablet Discontinued ORAL N/A Mar 20, 1995
EQ 250MG BASE

tablet Discontinued ORAL N/A Mar 20, 1995





25. ROXANE

Roxane Laboratories Inc has filed for 2 different strengths of generic version for Naproxen 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
EQ 500MG BASE

tablet Discontinued ORAL N/A Dec 21, 1993
EQ 250MG BASE

tablet Discontinued ORAL N/A Dec 21, 1993





26. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Naproxen 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
EQ 250MG BASE

tablet Discontinued ORAL N/A Dec 5, 1994
EQ 500MG BASE

tablet Discontinued ORAL N/A Dec 5, 1994


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
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





27. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 2 different strengths of generic version for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE

tablet Prescription ORAL AB Oct 30, 2019
EQ 500MG BASE

tablet Prescription ORAL AB Oct 30, 2019





28. STRIDES SOFTGELS

Strides Softgels Pte Ltd has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Strides Softgels.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 200MG BASE

capsule Discontinued ORAL N/A Aug 17, 2022





29. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Discontinued ORAL N/A May 20, 2011





30. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Naproxen 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
EQ 250MG BASE

tablet Discontinued ORAL N/A Dec 21, 1993
EQ 500MG BASE

tablet Discontinued ORAL N/A Dec 21, 1993


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Stouffville Teva Canada Limited
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





31. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Naproxen 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
EQ 500MG BASE

tablet Discontinued ORAL N/A Jan 27, 1994
EQ 250MG BASE

tablet Discontinued ORAL N/A Jan 27, 1994





32. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Naproxen Sodium. 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
EQ 250MG BASE

tablet Discontinued ORAL N/A May 31, 1995
EQ 500MG BASE

tablet Discontinued ORAL N/A May 31, 1995





33. YICHANG HUMANWELL

Yichang Humanwell Pharmaceutical Co Ltd has filed for 1 generic for Naproxen Sodium. Given below are the details of the strengths of this generic introduced by Yichang Humanwell.

Strength Dosage Form Availability Application Pathway TE code Launch Date
220MG

tablet Over the counter ORAL N/A Aug 30, 2019


Manufacturing Plant Locations
New

Yichang Humanwell'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 Yichang Humanwell as present at those locations.

Country City Firm Name
China
Yichang Yichang Humanwell Oral Solid Dosage Plant