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Last Updated: November 22, 2024

RIZATRIPTAN BENZOATE - Generic Drug Details


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What are the generic sources for rizatriptan benzoate and what is the scope of patent protection?

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, Natco Pharma Ltd, Norvium Bioscience, Panacea, Sandoz, Unichem, Organon Llc, Alkem Labs Ltd, Avet Lifesciences, Chartwell Rx, Creekwood Pharms, Invagen Pharms, Mylan Pharms Inc, 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.

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
Jubilant Generics RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 203334-002 Oct 16, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Pharms Inc RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 201993-001 Dec 31, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 201967-001 Dec 31, 2012 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Pharms Inc RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET;ORAL 201993-002 Dec 31, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 Llc MAXALT rizatriptan benzoate TABLET;ORAL 020864-002 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
Organon Llc MAXALT rizatriptan benzoate TABLET;ORAL 020864-001 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for RIZATRIPTAN BENZOATE

Country Patent Number Title Estimated Expiration
South Korea 102272442 ⤷  Sign Up
South Korea 20160089335 계면활성제 또는 폴리알콜을 포함하지 않은 즉각적 습윤성의 경구용 필름 제형 (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL) ⤷  Sign Up
Canada 2919442 FORME POSOLOGIQUE ORALE EN FILM INSTANTANEMENT MOUILLABLE SANS TENSIOACTIF NI POLYOL (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL) ⤷  Sign Up
Japan 6482552 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RIZATRIPTAN BENZOATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0497512 9891028-4 Sweden ⤷  Sign Up 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
0497512 28/1998 Austria ⤷  Sign Up PRODUCT NAME: RIZATRIPTAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE RIZATRIPTANBENZOAT; NAT. REGISTRATION NO/DATE: 1-22636 - 1-22639 19980709; FIRST REGISTRATION: NL 21815 - 21818 19980211
0497512 C980019 Netherlands ⤷  Sign Up 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 SPC/GB98/035 United Kingdom ⤷  Sign Up PRODUCT NAME: RIZATRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY RIZATRIPTAN BENZOATE; REGISTERED: NL 21815 19980211; NL 21816 19980211; NL 21817 19980211; NL 21818 19980211; UK 00025/0369 19980624; UK 00025/0370 19980624; UK 00025/0371 19980624; UK 00025/0372 19980624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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