Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021006

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NDA 021006 describes FROVA, which is a drug marketed by Endo Pharms, Amneal Pharms Co, Glenmark Pharms Ltd, and Mylan, and is included in four NDAs. It is available from two suppliers. Additional details are available on the FROVA profile page.

The generic ingredient in FROVA is frovatriptan succinate. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the frovatriptan succinate profile page.
Summary for 021006
Tradename:FROVA
Applicant:Endo Pharms
Ingredient:frovatriptan succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021006
Suppliers and Packaging for NDA: 021006
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FROVA frovatriptan succinate TABLET;ORAL 021006 NDA Par Pharmaceutical 0603-3718 0603-3718-34 1 BLISTER PACK in 1 CARTON (0603-3718-34) > 9 TABLET, FILM COATED in 1 BLISTER PACK
FROVA frovatriptan succinate TABLET;ORAL 021006 NDA Endo Pharmaceuticals, Inc. 63481-025 63481-025-09 1 BLISTER PACK in 1 CARTON (63481-025-09) > 9 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021006
Tradename Dosage Ingredient NDA Submissiondate
FROVA TABLET;ORAL frovatriptan succinate 021006 2011-03-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Nov 8, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021006

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms FROVA frovatriptan succinate TABLET;ORAL 021006-001 Nov 8, 2001   Start Trial   Start Trial
Endo Pharms FROVA frovatriptan succinate TABLET;ORAL 021006-001 Nov 8, 2001   Start Trial   Start Trial
Endo Pharms FROVA frovatriptan succinate TABLET;ORAL 021006-001 Nov 8, 2001   Start Trial   Start Trial
Endo Pharms FROVA frovatriptan succinate TABLET;ORAL 021006-001 Nov 8, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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