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 31^st, 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

Recent Clinical Trials for MAXALT-MLT

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

Sponsor	Phase
Robert W. Baloh	Phase 2/Phase 3
Henry M. Jackson Foundation for the Advancement of Military Medicine	N/A
Beth Israel Deaconess Medical Center	Phase 4

See all MAXALT-MLT clinical trials

Pharmacology for MAXALT-MLT

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 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

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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
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

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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	020865-001	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
>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.

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Country	Patent Number	Title	Estimated Expiration
China	1161834		⤷ Sign Up
Yugoslavia	48236		⤷ Sign Up
France	2366835		⤷ Sign Up
Spain	8401720		⤷ Sign Up
Greece	3036864		⤷ Sign Up
Czech Republic	283018	Deriváty imidazolu, triazolu a tetrazolu a farmaceutické přípravky na jejich bázi (IMIDAZOLE, TRIAZOLE AND TETRAZOLE DERIVATIVES, PROCESS OF THEIR PREPARATION, THEIR USE AND PHARMACEUTICALS BASED THEREON)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MAXALT-MLT

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