Sumatriptan - Generic Drug Details
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What are the generic sources for sumatriptan and what is the scope of patent protection?
Sumatriptan
is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Cipla, Florida, Lannett Co Inc, Padagis Israel, Tonix Meds, Meridian Medcl, Antares Pharma Inc, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz, Somerset, Steriscience, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Endo Ventures Ltd, Currax, Teva Branded Pharm, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty-seven NDAs. There are thirty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sumatriptan has ninety-one patent family members in twenty-nine countries.
There are twenty-four drug master file entries for sumatriptan. Eight suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for sumatriptan
International Patents: | 91 |
US Patents: | 39 |
Tradenames: | 10 |
Applicants: | 40 |
NDAs: | 47 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 70 |
Clinical Trials: | 115 |
Patent Applications: | 5,959 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for sumatriptan |
Drug Sales Revenues: | Drug sales revenues for sumatriptan |
What excipients (inactive ingredients) are in sumatriptan? | sumatriptan excipients list |
DailyMed Link: | sumatriptan at DailyMed |
Recent Clinical Trials for sumatriptan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Radboud University Medical Center | Phase 2 |
Canisius-Wilhelmina Hospital | Phase 2 |
Leiden University Medical Center | Phase 2 |
Generic filers with tentative approvals for SUMATRIPTAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 100MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 50MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 25MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for sumatriptan
Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Medical Subject Heading (MeSH) Categories for sumatriptan
Anatomical Therapeutic Chemical (ATC) Classes for sumatriptan
US Patents and Regulatory Information for sumatriptan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078295-002 | Aug 10, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Currax | ONZETRA XSAIL | sumatriptan succinate | POWDER;NASAL | 206099-001 | Jan 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Roxane | SUMATRIPTAN SUCCINATE | sumatriptan succinate | TABLET;ORAL | 078241-003 | Aug 10, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva Branded Pharm | ZECUITY | sumatriptan succinate | SYSTEM;IONTOPHORESIS | 202278-001 | Jan 17, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva Branded Pharm | ZECUITY | sumatriptan succinate | SYSTEM;IONTOPHORESIS | 202278-001 | Jan 17, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Par Sterile Products | SUMATRIPTAN SUCCINATE | sumatriptan succinate | INJECTABLE;SUBCUTANEOUS | 077871-001 | Jul 9, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for sumatriptan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-002 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-001 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-002 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for sumatriptan
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Galpharm Healthcare Ltd. | Sumatriptan Galpharm | sumatriptan | EMEA/H/C/002140 |
Refused | yes | no | no | 2012-02-09 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for sumatriptan
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2012513412 | ⤷ Sign Up | |
Mexico | 2023002506 | FORMULACIONES DE EPINEFRINA INTRANASAL Y METODOS PARA EL TRATAMIENTO DE ENFERMEDADES. (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE.) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2010075465 | ⤷ Sign Up | |
Hungary | E060917 | ⤷ Sign Up | |
China | 116549389 | 鼻内肾上腺素制剂及治疗疾病的方法 (Intranasal epinephrine formulations and methods of treating diseases) | ⤷ Sign Up |
European Patent Office | 2381773 | COMPOSITIONS POUR ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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