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Last Updated: October 26, 2021

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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 Astrazeneca, Alembic Pharms Ltd, Apotex Inc, Glenmark Generics, Jubilant Generics, Macleods Pharms Ltd, Mylan, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Ani Pharms, Appco, Aurobindo Pharma Ltd, Invagen Pharms, Mylan Pharms Inc, Orchid Hlthcare, Pld Acquisitions Llc, Sun Pharma Global, Zydus Pharms, and IPR, and is included in twenty-five NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolmitriptan has forty-two patent family members in twenty-eight countries.

There are twenty drug master file entries for zolmitriptan. Fifteen suppliers are listed for this compound.

Drug Prices for zolmitriptan

See drug prices for zolmitriptan

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 2/Phase 3

See all zolmitriptan clinical trials

Paragraph IV (Patent) Challenges for ZOLMITRIPTAN
Tradename Dosage Ingredient NDA Submissiondate
ZOMIG SPRAY;NASAL zolmitriptan 021450 2016-06-09
ZOMIG SPRAY;NASAL zolmitriptan 021450 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
Aurobindo Pharma Ltd ZOLMITRIPTAN zolmitriptan TABLET;ORAL 207021-001 May 11, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-002 Sep 17, 2001 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Jubilant Generics ZOLMITRIPTAN zolmitriptan TABLET;ORAL 202279-001 Nov 20, 2014 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex Inc ZOLMITRIPTAN zolmitriptan TABLET;ORAL 202078-002 May 14, 2013 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Appco ZOLMITRIPTAN zolmitriptan TABLET;ORAL 206973-002 Jun 30, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alembic Pharms Ltd ZOLMITRIPTAN zolmitriptan TABLET;ORAL 204232-002 Sep 30, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Jubilant Generics ZOLMITRIPTAN zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 202956-002 Sep 17, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Astrazeneca ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-001 Nov 25, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-002 Nov 25, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-002 Nov 25, 1997 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-002 Sep 17, 2001 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for zolmitriptan

Country Patent Number Estimated Expiration
United Kingdom 0214845 ⤷  Free Forever Trial
Israel 149578 ⤷  Free Forever Trial
Hong Kong 1048442 ⤷  Free Forever Trial
Germany 60019162 ⤷  Free Forever Trial
Hong Kong 1053430 ⤷  Free Forever Trial
European Patent Office 1237551 ⤷  Free Forever Trial
Hungary 0203597 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for zolmitriptan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0486666 SPC/GB97/089 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: ZOLMITRIPTAN AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 12619/0116 19970307
0486666 C980001 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 21079, RVG 21080 19970925; FIRST REGISTRATION: GB PL 12619/0116 19970307
0463756 300048 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307
0486666 72/1997 Austria ⤷  Free Forever Trial PRODUCT NAME: ZOLMITRIPTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ZULAESSIGEN SALZES; NAT. REGISTRATION NO/DATE: 1-22068, 1-22069 19970819; FIRST REGISTRATION: GB 12619/0116, 12619/0117 19970307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Medtronic
Express Scripts
Dow
Colorcon

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