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Sumatriptan succinate - Generic Drug Details

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Sumatriptan succinate is the generic ingredient in eight branded drugs marketed by Teva Pharms Usa, Injectalia, Sagent Strides, Teva Parenteral, Antares Pharma Inc, Mylan Labs Ltd, Eurohlth Intl Sarl, Dr Reddys Labs Ltd, Aurobindo Pharma, Par Pharm, Glaxosmithkline, Watson Labs, Endo Ventures Ltd, Fresenius Kabi Usa, Teva, Sagent Agila, Roxane, Mylan, Dr Reddys Labs Inc, Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Sun Pharma Global, Apotex Inc, Sandoz, Par Sterile Products, Meridian Medcl, Teva Branded Pharm, Hikma Farmaceutica, Orchid Hlthcare, Wockhardt, Sun Pharm Inds, Hikma Pharms, and Avanir Pharms, and is included in thirty-nine NDAs. There are thirty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and forty-seven patent family members in thirty-seven countries.

There are twenty-three drug master file entries for sumatriptan succinate. Forty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: sumatriptan succinate

Tradenames:8
Patents:37
Applicants:33
NDAs:39
Drug Master File Entries: see list23
Suppliers / Packaging: see list46
Formulation / Manufacturing:see details

Pharmacology for Ingredient: sumatriptan succinate

Tentative approvals for SUMATRIPTAN SUCCINATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL25MG
<disabled><disabled>TABLET; ORAL50MG
<disabled><disabled>TABLET; ORAL100MG

Clinical Trials for: sumatriptan succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
ZEMBRACE SYMTOUCH
sumatriptan succinate
SOLUTION;SUBCUTANEOUS208223-001Jan 28, 2016RXNo<disabled><disabled>
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009RXYes8,267,903<disabled>Y <disabled>
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-001Jun 1, 1995RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: sumatriptan succinate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
IMITREX STATDOSE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-003Dec 23, 19964,816,470*PED<disabled>
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20096,681,810<disabled>
Glaxosmithkline
IMITREX
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-001Dec 28, 19924,816,470*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: sumatriptan 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
7,841,337Breath-actuated nasal delivery device<disabled in preview>
9,138,538Device for readying a needle free injector for delivery<disabled in preview>
8,511,303Nasal delivery devices<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: sumatriptan succinate

Country Document Number Estimated Expiration
South Korea20030093216<disabled in preview>
Russian Federation2428217<disabled in preview>
United Kingdom0623316<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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