Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Moodys
Baxter
Medtronic
Johnson and Johnson

Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204623

See Plans and Pricing

« Back to Dashboard

NDA 204623 describes PENNSAID, which is a drug marketed by Hznp and Nuvo Pharms Inc and is included in two NDAs. It is available from one supplier. 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. Seventy-eight suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 204623
Tradename:PENNSAID
Applicant:Hznp
Ingredient:diclofenac sodium
Patents:19
Formulation / Manufacturing:see details
Pharmacology for NDA: 204623
Suppliers and Packaging for NDA: 204623
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623 NDA Horizon Pharma Inc. 75987-040 75987-040-05 112 g in 1 BOTTLE, PUMP (75987-040-05)
PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623 NDA Horizon Pharma Inc. 75987-040 75987-040-74 2 g in 1 POUCH (75987-040-74)
Paragraph IV (Patent) Challenges for 204623
Tradename Dosage Ingredient NDA Submissiondate
PENNSAID SOLUTION;TOPICAL diclofenac sodium 204623 2014-06-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength2%
Approval Date:Jan 16, 2014TE:RLD:Yes
Patent:  Start TrialPatent 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:  Start TrialPatent Expiration:Apr 21, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
Patent:  Start TrialPatent 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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Baxter
Medtronic
McKesson
Harvard Business School

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 verifification 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.