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Frovatriptan succinate - Generic Drug Details

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Frovatriptan succinate is the generic ingredient in two branded drugs marketed by Endo Pharms, Glenmark Pharms Ltd, and Mylan Pharms Inc, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for frovatriptan succinate. Seven suppliers are listed for this compound.

Summary for Generic Name: frovatriptan succinate

Tradenames:2
Patents:2
Applicants:3
NDAs:3
Drug Master File Entries: see list3
Suppliers / Packaging: see list7
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: frovatriptan succinate

Clinical Trials for: frovatriptan succinate

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, 2001RXYes5,827,871<disabled> <disabled>
Mylan Pharms Inc
FROVATRIPTAN SUCCINATE
frovatriptan succinate
TABLET;ORAL202931-001Aug 28, 2014RXNo<disabled><disabled>
Glenmark Pharms Ltd
FROVATRIPTAN SUCCINATE
frovatriptan succinate
TABLET;ORAL204730-001Mar 11, 2016RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: frovatriptan succinate

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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, 20015,917,054<disabled>
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,464,864<disabled>
Endo Pharms
FROVA
frovatriptan succinate
TABLET;ORAL021006-001Nov 8, 20015,618,948<disabled>
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Non-Orange Book Patents for Generic Ingredient: frovatriptan succinate

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 Ingredient: frovatriptan succinate

Country Document Number Estimated Expiration
New Zealand243288<disabled in preview>
Canada2113726<disabled in preview>
HungaryT68961<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: FROVATRIPTAN SUCCINATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2002Austria<disabled>PRODUCT NAME: FROVATRIPAN; NAT. REGISTRATION NO/DATE: 1-24487 20020424; FIRST REGISTRATION: FR NL 24548 20001212
0591280/01Switzerland<disabled>FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
C0019France<disabled>PRODUCT NAME: FROVATRIPTAN SUCCINATE MONOHYDRATE; NAT. REGISTRATION NO/DATE: NL 24548 20001212; FIRST REGISTRATION: FR - NL 24548 20001212
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