You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 19, 2026

Details for New Drug Application (NDA): 204623


✉ Email this page to a colleague

« Back to Dashboard


NDA 204623 describes PENNSAID, which is a drug marketed by Horizon and Nuvo Pharms Inc and is included in two NDAs. There are nineteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PENNSAID profile page.

The generic ingredient in PENNSAID is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-seven suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 204623
Tradename:PENNSAID
Applicant:Horizon
Ingredient:diclofenac sodium
Patents:19

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 16, 2014TE:RLD:Yes
Patent:⤷  Get Started FreePatent Expiration:Jul 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
Patent:⤷  Get Started FreePatent Expiration:Apr 21, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
Patent:⤷  Get Started FreePatent Expiration:Aug 9, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.

Complete Access Available with Subscription

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

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
© Copyright 2002-2026 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Generic Entry Opportunies 2026 - 2027
 NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links