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Sumatriptan succinate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for sumatriptan succinate?

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, West-ward Pharms Int, 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-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has four hundred and twenty-eight patent family members in thirty-seven countries.

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

Summary for Generic Name: sumatriptan succinate

Tradenames:8
Patents:36
Applicants:33
NDAs:39
Drug Master File Entries: see list23
Suppliers / Packagers: see list47
Bulk Api Vendors: see list66
Clinical Trials: see list81
Patent Applications: see list1,723
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sumatriptan succinate at DailyMed

Pharmacology for Ingredient: sumatriptan succinate

Tentative approvals for SUMATRIPTAN SUCCINATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL25MG
► Subscribe► SubscribeTABLET; ORAL50MG
► Subscribe► SubscribeTABLET; ORAL100MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm
ZECUITY
sumatriptan succinate
SYSTEM;IONTOPHORESIS202278-001Jan 17, 2013DISCNYesNo9,272,137► SubscribeY ► Subscribe
Avanir Pharms
ONZETRA XSAIL
sumatriptan succinate
POWDER;INHALATION206099-001Jan 27, 2016RXYesYes9,119,932► SubscribeY ► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009RXYesYes6,135,979► SubscribeY ► Subscribe
Sandoz
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL076976-001Aug 10, 2009DISCNNoNo► Subscribe► Subscribe
Aurobindo Pharma
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL078327-003Aug 10, 2009RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sumatriptan succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 20095,891,086► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-001Jun 1, 19955,037,845*PED► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-002Jun 1, 19954,816,470*PED► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-003Jun 1, 19956,368,627*PED► Subscribe
Glaxosmithkline
IMITREX STATDOSE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-003Dec 23, 19965,037,845*PED► Subscribe
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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
8,511,303Nasal delivery devices► Subscribe
9,144,652Powder delivery devices► Subscribe
7,347,201Nasal delivery devices► Subscribe
8,663,158Needleless injector drug capsule and a method for filling thereof► Subscribe
7,543,581Nasal devices► Subscribe
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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
Spain2395251► Subscribe
Hong Kong1039459► Subscribe
Denmark1399203► Subscribe
Russian Federation2428217► Subscribe
Norway20071661► Subscribe
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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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