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Last Updated: November 4, 2024

MAXALT-MLT Drug Patent Profile


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Which patents cover Maxalt-mlt, and when can generic versions of Maxalt-mlt launch?

Maxalt-mlt is a drug marketed by Organon and is included in one NDA.

The generic ingredient in MAXALT-MLT is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Maxalt-mlt

A generic version of MAXALT-MLT was approved as rizatriptan benzoate by AUROBINDO PHARMA LTD on December 31st, 2012.

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Summary for MAXALT-MLT
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 114
Clinical Trials: 9
What excipients (inactive ingredients) are in MAXALT-MLT?MAXALT-MLT excipients list
DailyMed Link:MAXALT-MLT at DailyMed
Drug patent expirations by year for MAXALT-MLT
Drug Sales Revenue Trends for MAXALT-MLT

See drug sales revenues for MAXALT-MLT

Recent Clinical Trials for MAXALT-MLT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Robert W. BalohPhase 2/Phase 3
Henry M. Jackson Foundation for the Advancement of Military MedicineN/A
Beth Israel Deaconess Medical CenterPhase 4

See all MAXALT-MLT clinical trials

Paragraph IV (Patent) Challenges for MAXALT-MLT
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

US Patents and Regulatory Information for MAXALT-MLT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 Jun 29, 1998 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-002 Jun 29, 1998 AB RX Yes Yes ⤷  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 MAXALT-MLT

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 ⤷  Sign Up ⤷  Sign Up
Organon MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 020865-001 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 020865-002 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 MAXALT-MLT

See the table below for patents covering MAXALT-MLT around the world.

Country Patent Number Title Estimated Expiration
South Africa 8208371 ⤷  Sign Up
United Kingdom 9102222 ⤷  Sign Up
Algeria 481 Produit manufactures façonnes solides. ⤷  Sign Up
Austria 27058 ⤷  Sign Up
Canada 2149659 PROCEDE D'APPLICATION D'UNE MARQUE SUR UNE FORME GALENIQUE A DISSOLUTION RAPIDE (METHOD OF APPLYING AN INDICIA TO A FAST-DISSOLVING DOSAGE FORM) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MAXALT-MLT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0497512 98C0037 France ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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