Rizatriptan benzoate - Generic Drug Details
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What are the generic drug 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, 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
International Patents: | 20 |
US Patents: | 1 |
Tradenames: | 4 |
Applicants: | 20 |
NDAs: | 28 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Clinical Trials: | 5 |
Patent Applications: | 1,620 |
Drug Prices: | Drug price trends for rizatriptan benzoate |
What excipients (inactive ingredients) are in rizatriptan benzoate? | rizatriptan benzoate excipients list |
DailyMed Link: | rizatriptan benzoate at DailyMed |
Recent Clinical Trials for rizatriptan benzoate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Sharp & Dohme Corp. | Phase 3 |
Pharmacology for rizatriptan benzoate
Drug Class | Serotonin-1b and Serotonin-1d Receptor Agonist |
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
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
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 |
Organon Llc | MAXALT | rizatriptan benzoate | TABLET;ORAL | 020864-002 | 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 |
Brazil | 112016002074 | forma de dosagem de película oral instantaneamente molhável sem tensoativo ou poli-álcool | ⤷ 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 |
0497512 | SPC/GB98/035 | United Kingdom | ⤷ Try a Trial | 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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