Details for New Drug Application (NDA): 022202

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NDA 022202 describes ZIPSOR, which is a drug marketed by Assertio and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZIPSOR profile page.

The generic ingredient in ZIPSOR is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

Summary for 022202

Tradename:	ZIPSOR
Applicant:	Assertio
Ingredient:	diclofenac potassium
Patents:	6

Pharmacology for NDA: 022202

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 022202

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202	NDA	Assertio Therapeutics, Inc.	13913-008	13913-008-12	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)
ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202	NDA AUTHORIZED GENERIC	Leading Pharma, LLC	69315-275	69315-275-20	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jun 16, 2009	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 25, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	7,662,858	Patent Expiration:	Feb 24, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Patent:	7,884,095	Patent Expiration:	Feb 24, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN

Expired US Patents for NDA 022202

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,287,594	⤷ Subscribe
Assertio	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,365,180	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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