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Generated: October 23, 2017

DrugPatentWatch Database Preview

Sumatriptan succinate - Generic Drug Details

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What are the generic sources for sumatriptan succinate and what is the scope of sumatriptan succinate freedom to operate?

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 Inc, Par Sterile Products, Sandoz, 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 forty-four 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 five tentative approvals for this compound.

Summary for Generic Name: sumatriptan succinate

US Patents:36
Tradenames:8
Applicants:34
NDAs:39
Drug Master File Entries: see list23
Suppliers / Packagers: see list46
Bulk Api Vendors: see list66
Clinical Trials: see list251
Patent Applications: see list1,770
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. Strength Dosage Form
u► SubscribeEQ 25MG BASETABLET;ORAL
u► SubscribeEQ 100MG BASETABLET;ORAL
u► SubscribeEQ 50MG BASETABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL076840-001Feb 9, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL078295-003Aug 10, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Antares Pharma Inc
SUMATRIPTAN SUCCINATE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS078319-002Dec 10, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Hikma Farmaceutica
SUMATRIPTAN SUCCINATE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS200183-001Sep 16, 2013APRXNoNo► Subscribe► Subscribe► Subscribe
Sagent Strides
SUMATRIPTAN SUCCINATE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS090314-001Jun 10, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Teva Branded Pharm
ZECUITY
sumatriptan succinate
SYSTEM;IONTOPHORESIS202278-001Jan 17, 2013DISCNYesNo► Subscribe► Subscribe ► Subscribe
Teva Branded Pharm
ZECUITY
sumatriptan succinate
SYSTEM;IONTOPHORESIS202278-001Jan 17, 2013DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Hikma Pharms
SUMATRIPTAN SUCCINATE
sumatriptan succinate
TABLET;ORAL078298-002May 21, 2013DISCNNoNo► Subscribe► 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, 2009► Subscribe► Subscribe
Glaxosmithkline
IMITREX STATDOSE
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-003Dec 23, 1996► Subscribe► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009► Subscribe► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-002Jun 1, 1995► Subscribe► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS020080-001Dec 28, 1992► Subscribe► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-003Jun 1, 1995► Subscribe► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009► Subscribe► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-001Jun 1, 1995► Subscribe► Subscribe
Glaxosmithkline
IMITREX
sumatriptan succinate
TABLET;ORAL020132-001Jun 1, 1995► Subscribe► Subscribe
Endo Ventures Ltd
SUMAVEL DOSEPRO
sumatriptan succinate
INJECTABLE;SUBCUTANEOUS022239-001Jul 15, 2009► Subscribe► 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
8,596,278Nasal devices► Subscribe
9,144,652Powder delivery devices► Subscribe
8,511,303Nasal delivery devices► Subscribe
8,663,158Needleless injector drug capsule and a method for filling thereof► Subscribe
9,132,249Nasal devices► Subscribe
8,522,778Nasal devices► Subscribe
7,347,201Nasal delivery devices► Subscribe
7,740,014Nasal devices► Subscribe
8,555,878Nasal delivery device► Subscribe
8,715,259Casing► 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
United Kingdom0706744► Subscribe
Canada2944660► Subscribe
Brazil9612003► Subscribe
Denmark1799290► Subscribe
Japan2013543773► Subscribe
South Korea20000005273► Subscribe
Spain2439274► Subscribe
United Kingdom2408214► Subscribe
Japan5662312► Subscribe
South Korea20070085256► 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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Chubb
Cipla
Accenture
US Army
AstraZeneca
Baxter
Covington
Harvard Business School
UBS

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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