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Last Updated: November 2, 2024

DICLOFENAC SODIUM Drug Patent Profile


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When do Diclofenac Sodium patents expire, and when can generic versions of Diclofenac Sodium launch?

Diclofenac Sodium is a drug marketed by Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Taro, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Sciegen Pharms Inc, Apotex, Epic Pharma Llc, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Unique, Dexcel Ltd, Riconpharma Llc, Vpna, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms. and is included in sixty-three NDAs.

The generic ingredient in DICLOFENAC SODIUM is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diclofenac Sodium

A generic version of DICLOFENAC SODIUM was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9th, 2012.

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Drug patent expirations by year for DICLOFENAC SODIUM
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Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DYLOJECT Injection diclofenac sodium 37.5 mg/mL, 1 mL single-dose vials 022396 1 2015-12-15
PENNSAID Topical Solution diclofenac sodium 2.0% 204623 1 2014-06-03
PENNSAID Topical Solution diclofenac sodium 1.5% 020947 1 2012-07-11
SOLARAZE Topical Gel diclofenac sodium 3% 021005 1 2009-12-16

US Patents and Regulatory Information for DICLOFENAC SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Fl Inc DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 201089-002 Jul 9, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281-003 Feb 12, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 206715-001 Aug 7, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074986-002 Feb 26, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074459-001 Jun 25, 1997 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074376-001 Sep 28, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pliva DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074432-002 Jul 29, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DICLOFENAC SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ⤷  Sign Up ⤷  Sign Up
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DICLOFENAC SODIUM

See the table below for patents covering DICLOFENAC SODIUM around the world.

Country Patent Number Title Estimated Expiration
Japan 2954356 ⤷  Sign Up
Portugal 739197 ⤷  Sign Up
European Patent Office 0739197 CONSERVATION DE COMPOSITIONS DE MEDICAMENTS OPHTALMIQUES CONTENANT DES COMPOSES D'AMMONIUM QUATERNAIRE POLYMERE (PRESERVED OPHTHALMIC DRUG COMPOSITIONS CONTAINING POLYMERIC QUATERNARY AMMONIUM COMPOUNDS) ⤷  Sign Up
Spain 2160722 ⤷  Sign Up
Hong Kong 1012556 ⤷  Sign Up
Denmark 0739197 ⤷  Sign Up
Australia 4162296 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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