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Last Updated: May 21, 2022

PENNSAID Drug Patent 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. One hundred and four suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

DrugPatentWatch® 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

See drug prices for PENNSAID

Drug Sales Revenue Trends for PENNSAID

See drug sales revenues for PENNSAID

Paragraph IV (Patent) Challenges for PENNSAID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PENNSAID Topical Solution diclofenac sodium 2.0% 204623 1 2014-06-03
PENNSAID Topical Solution diclofenac sodium 1.5% 020947 1 2012-07-11

US Patents and Regulatory Information for PENNSAID

PENNSAID is protected by twenty-one US patents.

Patents protecting PENNSAID

Treatment of pain with topical diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE

Treatment of pain with topical diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS

Treatment of pain with topical diclofenac compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.

Treatment of pain with topical diclofenac compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Treatment of pain with topical diclofenac compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE

Treatment of pain with topical diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Treatment of pain with topical diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC FOR TREATING PAIN

Treatment of pain with topical diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN

Treatment of pain with topical diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN

Treatment of pain with topical diclofenac
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN

Diclofenac topical formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Horizon PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623-001 Jan 16, 2014 RX Yes Yes 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

International Patents for PENNSAID

See the table below for patents covering PENNSAID around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1134024 DICLOFENAC GEL See Plans and Pricing
New Zealand 577020 DICLOFENAC GEL CONTAINING DIMETHYL SULFOXIDE (DMSO) See Plans and Pricing
Australia 2007311019 Diclofenac gel See Plans and Pricing
Brazil PI0717769 FORMULAÇÃO DE GEL, MÉTODO PARA O TRATAMENTO DA OSTEOARTRITE EM UM INDIVÍDUO SOFRENDO DE DOR ARTICULAR, E, USO DE DICLOFENAC DE SÓDIO See Plans and Pricing
European Patent Office 2626063 Gel de diclofénac (Diclofenac gel) See Plans and Pricing
Japan 2010506952 See Plans and Pricing
China 101588791 Diclofenac gel See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Dow
McKesson
Harvard Business School
Baxter

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.