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Last Updated: July 13, 2020

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PENNSAID Drug Profile


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Which patents cover Pennsaid, and what generic alternatives are available?

Pennsaid 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.

This drug has eighteen patent family members in fourteen countries.

The generic ingredient in PENNSAID is diclofenac sodium. There are forty-seven drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Pennsaid

A generic version of PENNSAID was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26th, 1996.

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Drug patent expirations by year for PENNSAID
Drug Prices for PENNSAID

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Drug Sales Revenue Trends for PENNSAID

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Recent Clinical Trials for PENNSAID

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SponsorPhase
Arthritis Treatment Center, MarylandPhase 3
Medtronic - MITGPhase 3
Nathan Wei, MD, FACP, FACR:Phase 3

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Paragraph IV (Patent) Challenges for PENNSAID
Tradename Dosage Ingredient NDA Submissiondate
PENNSAID SOLUTION;TOPICAL diclofenac sodium 204623 2014-06-03
PENNSAID SOLUTION;TOPICAL diclofenac sodium 020947 2012-07-11

US Patents and Regulatory Information for PENNSAID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Dow
McKesson
Harvard Business School
Baxter

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