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Last Updated: March 28, 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, Akorn, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, 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.

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Usa DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075281-003 Feb 12, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 206715-001 Aug 7, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074986-002 Feb 26, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074459-001 Jun 25, 1997 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 ⤷  Try a Trial ⤷  Try a Trial
>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
Germany 69522094 ⤷  Try a Trial
Australia 686917 ⤷  Try a Trial
Australia 4162296 ⤷  Try a Trial
Denmark 0739197 ⤷  Try a Trial
Canada 2180554 CONSERVATION DE COMPOSITIONS DE MEDICAMENTS OPHTALMIQUES CONTENANT DES COMPOSES D'AMMONIUM QUATERNAIRE POLYMERE (PRESERVED OPHTHALMIC DRUG COMPOSITIONS CONTAINING POLYMERIC QUATERNARY AMMONIUM COMPOUNDS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.