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FROVA Drug Profile

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Frova is a drug marketed by Endo Pharms, Glenmark Pharms Ltd, and Mylan Pharms Inc. and is included in three NDAs. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in thirty-three countries.

The generic ingredient in FROVA is frovatriptan succinate. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the frovatriptan succinate profile page.

Summary for Tradename: FROVA

Patents:2
Applicants:3
NDAs:3
Suppliers / Packagers: see list5
Drug Prices: :see details

Clinical Trials for: FROVA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 2001RXYes5,464,864Nov 7, 2015
Mylan Pharms Inc
FROVATRIPTAN SUCCINATE
frovatriptan succinate
TABLET;ORAL202931-001Aug 28, 2014RXNo
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 2001RXYes5,827,871Oct 27, 2015
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Expired Patents for Tradename: FROVA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,464,864<disabled>
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,962,501<disabled>
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,917,054<disabled>
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Paragraph IV activity for: FROVA

Drugname Dosage Strength RLD Submissiondate
frovatriptan succinateTablets2.5 mgFrova3/9/2011

Non-Orange Book Patents for Tradename: FROVA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,637,611 Medicaments<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FROVA

Country Document Number Estimated Expiration
China1034072<disabled in preview>
Finland935842<disabled in preview>
Germany10299042<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FROVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB03/014United Kingdom<disabled>PRODUCT NAME: 3 METHYLAMINO-6-CARBOXAMIDO-1, 2, 3, 4-TETRAHYDROCARBAZOLE ("FROVATRIPTAN") INCLUDING A SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: FR NL 24548 20001212; UK PL 16239/0017 20021007; UK PL 16239/0018 20021007
/2002Austria<disabled>PRODUCT NAME: FROVATRIPAN; NAT. REGISTRATION NO/DATE: 1-24487 20020424; FIRST REGISTRATION: FR NL 24548 20001212
00103Netherlands<disabled>PRODUCT NAME: FROVATRIPTAN EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 27211RVG 27212 2002190419; FIRST REGISTRATION: NL 24548 20001212
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