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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021299

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NDA 021299 describes PEXEVA, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the PEXEVA profile page.

The generic ingredient in PEXEVA is paroxetine mesylate. There are thirty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.

Summary for 021299

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021299

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 021299

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEXEVA paroxetine mesylate TABLET;ORAL 021299 NDA Sebela Pharmaceuticals Inc. 54766-201 54766-201-01 30 TABLET, FILM COATED in 1 BOTTLE (54766-201-01)
PEXEVA paroxetine mesylate TABLET;ORAL 021299 NDA Sebela Pharmaceuticals Inc. 54766-202 54766-202-01 30 TABLET, FILM COATED in 1 BOTTLE (54766-202-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 3, 2003TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:DEPRESSION
Patent:► SubscribePatent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:OBSESSIVE COMPULSIVE DISORDER
Patent:► SubscribePatent Expiration:Jun 10, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PANIC DISORDER

Expired Orange Book Patents for NDA: 021299

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland LtdPEXEVAparoxetine mesylateTABLET;ORAL021299-001Jul 3, 2003► Subscribe► Subscribe
Sebela Ireland LtdPEXEVAparoxetine mesylateTABLET;ORAL021299-004Jul 3, 2003► Subscribe► Subscribe
Sebela Ireland LtdPEXEVAparoxetine mesylateTABLET;ORAL021299-003Jul 3, 2003► Subscribe► Subscribe
Sebela Ireland LtdPEXEVAparoxetine mesylateTABLET;ORAL021299-002Jul 3, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Army
Boehringer Ingelheim
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Moodys
UBS
Fuji
Cantor Fitzgerald
Citi
Farmers Insurance

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