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, 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: | 19 |
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 |
Drug Sales Revenues: | Drug sales revenues 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET;ORAL | 202490-001 | Dec 31, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Unichem | RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET;ORAL | 207836-002 | Mar 7, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | RIZATRIPTAN BENZOATE | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 078739-001 | Jul 1, 2013 | 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 | 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 |
---|---|---|---|
Mexico | 366595 | FORMA DE DOSIFICACION DE PELICULA ORAL HUMECTABLE AL INSTANTE SIN SURFACTANTE O POLIALCOHOL. (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL.) | ⤷ Try a Trial |
China | 105530921 | Instantly wettable oral film dosage form without surfactant or polyalcohol | ⤷ Try a Trial |
Japan | 6482552 | ⤷ 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 | 28/1998 | Austria | ⤷ Try a Trial | 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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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