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FROVA

NDA

FROVATRIPTAN SUCCINATE | N021006 | ENDO OPERATIONS LTD

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Endo Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. et al 1:2011cv00717 3 patentsANDA 202931frovatriptan	D. Del.	2011-08-16	Terminated 2014-06-20	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Frova (2023)

Total Spending

$357K

Total Claims

138

Beneficiaries

Avg Cost/Unit

$125.98

Spending Trend

$995K(2019)→$1.0M(2020)→$962K(2021)→$805K(2022)→$357K(2023)

YoY Change:+10.4%

5yr CAGR:+9.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDFROVATRIPTAN SUCCINATE MONOHYDRATE

DMF 229522009

MATRIX PHARMACORP PRIVATE LTDFROVATRIPTAN SUCCINATE MONOHYDRATE

DMF 243112010

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFROVATRIPTAN SUCCINATE MONOHYDRATE

DMF 272842013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Aug 27, 2018	SUPPL -22	View Letter (PDF)
Oct 15, 2013	SUPPL -19	View Letter (PDF)
Mar 5, 2009	SUPPL -6	View Letter (PDF)
Mar 5, 2009	SUPPL -9	View Letter (PDF)
Mar 5, 2009	SUPPL -10	View Letter (PDF)
Nov 8, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2.5MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 8, 2001

No patent or exclusivity listings for this strength.