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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204623

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NDA 204623 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-nine suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for 204623

Tradename:1
Applicant:1
Ingredient:1
Patents:19
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
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 75987-040-74 2 g in 1 POUCH (75987-040-74)
PENNSAID diclofenac sodium SOLUTION;TOPICAL 204623 NDA Horizon Pharma Inc. 75987-040 75987-040-05 112 g in 1 BOTTLE, PUMP (75987-040-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength2%
Approval Date:Jan 16, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 16, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent 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:► SubscribePatent Expiration:Apr 21, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS


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Serving leading biopharmaceutical companies globally:

Express Scripts
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Chinese Patent Office
Covington

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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