Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: July 23, 2017
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-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 8 |
| Patents: | 37 |
| Applicants: | 34 |
| NDAs: | 39 |
| Drug Master File Entries: see list | 23 |
| Suppliers / Packagers: see list | 47 |
| Bulk Api Vendors: see list | 66 |
| Clinical Trials: see list | 244 |
| Patent Applications: see list | 1,723 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | sumatriptan succinate at DailyMed |
| Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | EQ 25MG BASE | TABLET;ORAL |
| ► Subscribe | ► Subscribe | EQ 100MG BASE | TABLET;ORAL |
| ► Subscribe | ► Subscribe | EQ 50MG BASE | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 079240-002 | Sep 18, 2009 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Aurobindo Pharma | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078327-003 | Aug 10, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hikma Pharms | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078298-003 | May 21, 2013 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Orchid Hlthcare | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078284-003 | Aug 10, 2009 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Hikma Pharms | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078298-001 | May 21, 2013 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | Jun 1, 1995 | 5,037,845*PED | ► Subscribe | ||||||||||||||||||||||
Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | 6,251,091 | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | 6,368,627*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | 4,816,470*PED | ► Subscribe | ||||||||||||||||||||||
Endo Ventures Ltd | SUMAVEL DOSEPRO | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 022239-001 | Jul 15, 2009 | 5,957,886 | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,144,652 | Powder delivery devices | ► Subscribe | |||||||||||||||||||||||||||
| 8,596,278 | Nasal devices | ► Subscribe | |||||||||||||||||||||||||||
| 9,468,727 | Nasal delivery | ► Subscribe | |||||||||||||||||||||||||||
| 8,511,303 | Nasal delivery devices | ► Subscribe | |||||||||||||||||||||||||||
| 8,555,878 | Nasal delivery device | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom | 2424587 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2005500877 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1039459 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60239857 | ► Subscribe | |||||||||||||||||||||||||||
| China | 102000374 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ biopharmaceutical companies globally:
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.
Follow DrugPatentWatch:
Join the 22,093 other biopharmaceutical professionals who get our Drug Patent Expiration Alerts:
