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Last Updated: March 19, 2024

Rizatriptan benzoate - Generic Drug Details


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What are the generic sources for rizatriptan benzoate and what is the scope of freedom to operate?

Rizatriptan benzoate is the generic ingredient in four branded drugs marketed by Gensco, Organon, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Mylan Pharms Inc, Natco Pharma Ltd, Panacea, Sandoz, Unichem, Organon Llc, Alkem Labs Ltd, Avet Lifesciences, Chartwell Rx, Creekwood Pharms, Glenmark Generics, Invagen Pharms, and Teva Pharms, and is included in twenty-eight NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rizatriptan benzoate has twenty patent family members in sixteen countries.

There are twenty-two drug master file entries for rizatriptan benzoate. Twenty-four suppliers are listed for this compound.

Summary for rizatriptan benzoate
Drug Prices for rizatriptan benzoate

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Drug Sales Revenue Trends for rizatriptan benzoate

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Recent Clinical Trials for rizatriptan benzoate

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SponsorPhase
Merck Sharp & Dohme Corp.Phase 3

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Pharmacology for rizatriptan benzoate
Anatomical Therapeutic Chemical (ATC) Classes for rizatriptan benzoate
Paragraph IV (Patent) Challenges for RIZATRIPTAN BENZOATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MAXALT-MLT Orally Disintegrating Tablets rizatriptan benzoate 5 mg and 10 mg 020865 1 2006-02-17
MAXALT Tablets rizatriptan benzoate 5 mg and 10 mg 020864 1 2004-09-02

US Patents and Regulatory Information for rizatriptan benzoate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Invagen Pharms RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 204339-001 Jul 1, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 202244-001 Dec 31, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Natco Pharma Ltd RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 200482-001 Dec 31, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 203334-001 Oct 16, 2015 DISCN No No ⤷  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 rizatriptan benzoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc MAXALT rizatriptan benzoate TABLET;ORAL 020864-002 Jun 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for rizatriptan benzoate

Country Patent Number Title Estimated Expiration
European Patent Office 3027179 FORME POSOLOGIQUE ORALE EN FILM INSTANTANÉMENT MOUILLABLE SANS TENSIOACTIF NI POLYOL (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL) ⤷  Try a Trial
Russian Federation 2016106907 МГНОВЕННО СМАЧИВАЮЩАЯСЯ ПЕРОРАЛЬНАЯ ПЛЕНОЧНАЯ ЛЕКАРСТВЕННАЯ ФОРМА БЕЗ ПОВЕРХНОСТНО-АКТИВНОГО ВЕЩЕСТВА ИЛИ ПОЛИСПИРТА ⤷  Try a Trial
Denmark 3027179 ⤷  Try a Trial
South Africa 201600785 INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for rizatriptan benzoate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0497512 C980019 Netherlands ⤷  Try a Trial PRODUCT NAME: RIZATRIPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT, IN HET BIJZOND ER RIZATRIPTAN-BENZOAAT; REGISTRATION NO/DATE: RVG 21815 - RVG 21818 19980211
0497512 98C0037 France ⤷  Try a Trial PRODUCT NAME: RIZATRIPTAN BENZOATE; REGISTRATION NO/DATE IN FRANCE: NL 23 695 DU 19980817; REGISTRATION NO/DATE AT EEC: 21 815 DU 19980211
0497512 99C0011 Belgium ⤷  Try a Trial PRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211
0497512 9891028-4 Sweden ⤷  Try a Trial PRODUCT NAME: RIZATRIPTAN, N.N-DIMETYL-2-(5-(1, 2, 4-TRIAZOL-1-YLMETYL)-1H-INDOL-3-YL)ET)-1H-I, EVENTUELLT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT, SPECIELLT DA RIZATRIPTANBENSOAT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.