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Last Updated: October 27, 2020

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ZOMIG Drug Profile

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Which patents cover Zomig, and when can generic versions of Zomig launch?

Zomig is a drug marketed by Astrazeneca and IPR and is included in three NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in ZOMIG is zolmitriptan. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

US ANDA Litigation and Generic Entry Outlook for Zomig

A generic version of ZOMIG was approved as zolmitriptan by GLENMARK GENERICS on May 14th, 2013.

  Start Trial

Paragraph IV (Patent) Challenges for ZOMIG
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 ZOMIG

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-001 Feb 13, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca ZOMIG zolmitriptan SPRAY;NASAL 021450-004 Sep 30, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca ZOMIG-ZMT zolmitriptan TABLET, ORALLY DISINTEGRATING;ORAL 021231-002 Sep 17, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca ZOMIG zolmitriptan SPRAY;NASAL 021450-003 Sep 16, 2013 RX Yes No   Start Trial   Start Trial Y   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 ZOMIG

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
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-001 Nov 25, 1997   Start Trial   Start Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-002 Nov 25, 1997   Start Trial   Start Trial
Ipr ZOMIG zolmitriptan TABLET;ORAL 020768-002 Nov 25, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZOMIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 C980001 Netherlands   Start 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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