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, 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.

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:	1,089
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

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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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Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3

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Pharmacology for rizatriptan benzoate

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for rizatriptan benzoate

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avet Lifesciences	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	204090-002	Nov 26, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	203146-002	Sep 19, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unichem	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	207835-002	Mar 7, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Invagen Pharms	RIZATRIPTAN BENZOATE	rizatriptan benzoate	TABLET;ORAL	204339-001	Jul 1, 2013		DISCN	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

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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

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Country	Patent Number	Title	Estimated Expiration
Spain	2706481		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2015015303		⤷ Sign Up
European Patent Office	3427732	FORME POSOLOGIQUE DE FILM ORAL MOUILLABLE INSTANTANÉMENT SANS TENSIOACTIF OU POLYALCOOL (INSTANTLY WETTABLE ORAL FILM DOSAGE FORM WITHOUT SURFACTANT OR POLYALCOHOL)	⤷ Sign Up
Japan	2016527262	界面活性剤および多価アルコールを有さず直ちに湿潤可能な経口フィルム剤形	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for rizatriptan benzoate

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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	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	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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