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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson
Fuji
Queensland Health
Julphar
Harvard Business School
Boehringer Ingelheim
Baxter
Federal Trade Commission
Express Scripts

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020947

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NDA 020947 describes PENNSAID, which is a drug marketed by Horizon Pharma and Nuvo Pharms Inc and is included in two NDAs. It is available from two suppliers. 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. Eighty-six suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for NDA: 020947

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020947

Suppliers and Packaging for NDA: 020947

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL 020947 NDA STAT RX USA LLC 16590-453 16590-453-33 150 mL in 1 BOTTLE, DROPPER (16590-453-33)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 4, 2009TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jul 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
Patent:► SubscribePatent 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.
Patent:► SubscribePatent Expiration:Aug 9, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT


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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Dow
Fish and Richardson
US Army
Mallinckrodt
Cipla
Argus Health
Merck
McKinsey

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.

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