Zolmitriptan - Generic Drug Details
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What are the generic sources for zolmitriptan and what is the scope of patent protection?
Zolmitriptan
is the generic ingredient in three branded drugs marketed by Padagis Israel, Amneal, Alembic, Apotex Inc, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Astrazeneca, Ajanta Pharma Ltd, Ani Pharms, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Somerset Theraps Llc, Sun Pharma Global, Zydus Pharms, and IPR, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.There are twenty drug master file entries for zolmitriptan. Twenty-one suppliers are listed for this compound.
Summary for zolmitriptan
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 21 |
NDAs: | 26 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 99 |
Clinical Trials: | 23 |
Patent Applications: | 6,643 |
Drug Prices: | Drug price trends for zolmitriptan |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for zolmitriptan |
What excipients (inactive ingredients) are in zolmitriptan? | zolmitriptan excipients list |
DailyMed Link: | zolmitriptan at DailyMed |
Recent Clinical Trials for zolmitriptan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Food and Drug Administration (FDA) | Phase 1 |
Parc de Salut Mar | Phase 1 |
William Stoops | Early Phase 1 |
Pharmacology for zolmitriptan
Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for zolmitriptan
Paragraph IV (Patent) Challenges for ZOLMITRIPTAN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZOMIG | Nasal Spray | zolmitriptan | 2.5 mg/spray | 021450 | 1 | 2016-06-09 |
ZOMIG | Nasal Spray | zolmitriptan | 5 mg/spray | 021450 | 1 | 2013-11-14 |
US Patents and Regulatory Information for zolmitriptan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glenmark Pharms Ltd | ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 202560-002 | May 14, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Pld Acquisitions Llc | ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 207867-001 | Feb 27, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Orbion Pharms | ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 203726-002 | Oct 21, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glenmark Pharms Ltd | ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 202560-001 | May 14, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharma Global | ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 203476-002 | Nov 13, 2014 | 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 zolmitriptan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-003 | Sep 16, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Amneal | ZOMIG | zolmitriptan | SPRAY;NASAL | 021450-004 | Sep 30, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Ipr | ZOMIG | zolmitriptan | TABLET;ORAL | 020768-001 | Nov 25, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | ZOMIG-ZMT | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 021231-002 | Sep 17, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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