Pharmaceutical Business Intelligence

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PENNSAID Drug Profile

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Pennsaid is a drug marketed by Horizon Pharma and Nuvo Res Inc and is included in two NDAs. It is available from three suppliers. There are eighteen patents protecting this drug and two Paragraph IV challenges.

This drug has seventeen 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. Eighty suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for Tradename: PENNSAID

Suppliers / Packagers: see list3
Bulk Api Vendors: see list61
Clinical Trials: see list2
Formulation / Manufacturing:see details
Drug Prices:see details

Pharmacology for Tradename: PENNSAID

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYes8,741,956► subscribe ► subscribe
Horizon Pharma
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYes9,370,501► subscribe ► subscribe
Nuvo Res Inc
diclofenac sodium
SOLUTION;TOPICAL020947-001Nov 4, 2009RXYes8,618,164► subscribe ► subscribe
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Paragraph IV activity for: PENNSAID

Drugname Dosage Strength RLD Submissiondate
diclofenac sodiumTopical Solution2.0%Pennsaid6/3/2014
diclofenac sodiumTopical Solution1.5%Pennsaid7/11/2012

International Patent Family for Tradename: PENNSAID

Country Document Number Estimated Expiration
European Patent Office2086504► subscribe
Russian Federation2463038► subscribe
China104606126► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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.