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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 fifty 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
Drug Prices:see low prices

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
Sun Pharm Inds
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL078295-002Aug 10, 2009RXNo
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009RXYes8,343,130Oct 18, 2022Y
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009RXYes7,901,385Jul 31, 2026Y
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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
sumatriptan succinate
TABLET;ORAL020132-002Jun 1, 19955,037,845*PED<disabled>
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-002Jun 1, 19955,863,559*PED<disabled>
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20095,957,886<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
7,740,014Nasal devices<disabled in preview>
8,715,259Casing<disabled in preview>
9,072,857Nasal delivery device<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
Australia2002302868<disabled in preview>
China1736502<disabled in preview>
Canada2918226<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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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