Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Medtronic
Johnson and Johnson
Harvard Business School
Colorcon
McKinsey
Moodys

Last Updated: February 1, 2023

DICLOFENAC SODIUM Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Akorn, Aleor Dermaceuticals, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Padagis Israel, Perrigo Pharma Intl, Taro, Tolmar, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz Inc, Amneal, Apotex, Apotex Inc, Cadila, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Riconpharma Llc, Vpna, Actavis Labs Fl Inc, Exela Holdings, Sandoz, and Yung Shin Pharm. and is included in sixty 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
Drug Prices for DICLOFENAC SODIUM

See drug prices for DICLOFENAC SODIUM

Drug Sales Revenue Trends for DICLOFENAC SODIUM

See drug sales revenues for DICLOFENAC SODIUM

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
Exela Holdings DICLOFENAC SODIUM AND MISOPROSTOL diclofenac sodium; misoprostol TABLET, DELAYED RELEASE;ORAL 200540-002 Mar 14, 2014 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Carlsbad DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 075185-002 Nov 13, 1998 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising DICLOFENAC SODIUM diclofenac sodium SOLUTION;TOPICAL 206715-001 Aug 7, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pliva DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074432-002 Jul 29, 1999 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Unique Pharm Labs DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 090066-002 Dec 1, 2010 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx DICLOFENAC SODIUM diclofenac sodium TABLET, DELAYED RELEASE;ORAL 074376-002 Sep 28, 1995 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Falcon Pharms DICLOFENAC SODIUM diclofenac sodium SOLUTION/DROPS;OPHTHALMIC 020809-001 May 4, 1998 See Plans and Pricing See Plans and Pricing
>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
Denmark 0739197 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9614829 See Plans and Pricing
Japan H09503791 See Plans and Pricing
Australia 686917 See Plans and Pricing
Greece 3036622 See Plans and Pricing
Portugal 739197 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
AstraZeneca
McKesson
Moodys
Johnson and Johnson

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.