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Last Updated: March 18, 2024

Zolmitriptan - Generic Drug Details


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What are the generic drug 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 Generics, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Astrazeneca, Ajanta Pharma Ltd, Ani Pharms, Appco, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions 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 suppliers are listed for this compound.

Drug Prices for zolmitriptan

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Recent Clinical Trials for zolmitriptan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
William StoopsEarly Phase 1
National Institute on Drug Abuse (NIDA)Early Phase 1
Zosano Pharma CorporationPhase 1

See all zolmitriptan clinical trials

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
Zydus Pharms Usa Inc ZOLMITRIPTAN zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 202890-001 May 15, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd ZOLMITRIPTAN zolmitriptan TABLET;ORAL 204041-002 May 20, 2016 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics ZOLMITRIPTAN zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 202956-001 Sep 17, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics ZOLMITRIPTAN zolmitriptan TABLET;ORAL 201779-001 May 14, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd ZOLMITRIPTAN zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 204336-001 Oct 22, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-001 Nov 25, 1997 ⤷  Try a Trial ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 ⤷  Try a Trial ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-001 Feb 13, 2001 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-002 Sep 17, 2001 ⤷  Try a Trial ⤷  Try a Trial
Amneal ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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