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Last Updated: September 28, 2020

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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 Inc, 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. Fourteen 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
Zosano Pharma CorporationPhase 2/Phase 3
Contera PharmaPhase 2
Bukwang PharmaceuticalPhase 2

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
Orchid Hlthcare ZOLMITRIPTAN zolmitriptan TABLET;ORAL 203726-002 Oct 21, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms ZOLMITRIPTAN zolmitriptan TABLET;ORAL 204284-001 Apr 9, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ZOLMITRIPTAN zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 202855-001 Sep 20, 2019 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Astrazeneca ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003   Start Trial   Start Trial
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-002 Sep 17, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for zolmitriptan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0486666 72/1997 Austria   Start 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
0486666 SPC/GB97/089 United Kingdom   Start Trial PRODUCT NAME: ZOLMITRIPTAN AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 12619/0116 19970307
0463756 300048 Netherlands   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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