Viewing data from:

MAXALT-MLT

NDA

RIZATRIPTAN BENZOATE | N020865 | ORGANON LLC A SUB OF ORGANON AND CO

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from IntelGenx Corporation FDA-2013-P-1058 · 4 docket documents IntelGenx Corporation filed this citizen petition in August 2013 requesting that the FDA designate Rizatriptan Oral Film as therapeutically equivalent (AB) to the reference listed drug Maxalt-MLT (rizatriptan benzoate orally disintegrating tablet, NDA 20-865) under section 505(b)(2) of the Federal F	505(q)	2013-09-16	Withdrawn	IntelGenx Corporation

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

12 trials from ClinicalTrials.gov, 12 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)NCT00604812	Phase 1	Completed	Organon and Co	31	2007-12-17 → 2010-09-17
MK0462 in Treatment of Migraine With Recurrence (MK0462-022)NCT00897949	Phase 3	Completed	Organon and Co	1,473	1995-03 → 1996-07
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)NCT01004263	Phase 3	Completed	Organon and Co	674	2009-12-01 → 2011-04-18
Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)NCT00095004	Phase 3	Completed	Organon and Co	167	2004-10-21 → 2005-04-04
Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)NCT00092963	Phase 3	Completed	Organon and Co	529	2004-08-17 → 2005-01-14
A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis NCT00812006	Phase 3	Completed	Organon and Co	108	2009-03-24 → 2009-10-22
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)NCT00897104	Phase 3	Completed	Organon and Co	933	1995-08 → 1996-09
Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)NCT00898677	Phase 3	Completed	Organon and Co	1,268	1995-09 → 1996-09
Treatment of Multiple Attacks of Acute Migraine (0462-025)NCT00899379	Phase 3	Completed	Organon and Co	473	1995-04 → 1996-04
Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)NCT00516737	Phase 3	Completed	Organon and Co	207	2007-10-03 → 2008-04-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$44.26

per ea

Lowest NADAC/Unit

$44.26

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206014301MAXALT MLT 10 MG TABLET	$44.26	EA	Brand	$0.5293	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$571.40

Highest Price

$783.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0143-01MAXALT MLT 10MG	$783.44	FSS	Organon LLC	01/14/2027
78206-0143-01MAXALT MLT 10MG	$571.40	Big4	Organon LLC	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain19 active DMFs3 inactive

18 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDRIZATRIPTAN BENZOATE USP

DMF 180212005

MATRIX PHARMACORP PRIVATE LTDRIZATRIPTAN BENZOATE USP

DMF 190982006

DR REDDYS LABORATORIES LTDRIZATRIPTAN BENZOATE USP

DMF 191792006

NATCO PHARMA LTDRIZATRIPTAN BENZOATE

DMF 207812007

ALIVUS LIFE SCIENCES LTDRIZATRIPTAN BENZOATE USP

DMF 226762009

NATCO PHARMA LTDRIZATRIPTAN BENZOATE (ROUTE - 2; PRODUCT CODE: RTB)

DMF 227632009

SMS PHARMACEUTICALS LTDRIZATRIPTAN BENZOATE

DMF 230662009

SUN PHARMACEUTICAL INDUSTRIES LTDRIZATRIPTAN BENZOATE USP

DMF 235812010

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDRIZATRIPTAN BENZOATE

DMF 235982010

APITORIA PHARMA PRIVATE LTDRIZATRIPTAN BENZOATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 238142010

JUBILANT BIOSYS LTDRIZATRIPTAN BENZOATE USP

DMF 240542010

UNIMARK REMEDIES LTDRIZATRIPTAN BENZOATE

DMF 241772010

MACLEODS PHARMACEUTICALS LTDRIZATRIPTAN BENZOATE

DMF 245522011

ALKEM LABORATORIES LTDRIZATRIPTAN BENZOATE USP

DMF 248842011

INKE SARIZATRIPTAN BENZOATE

DMF 256232011

EMCURE PHARMACEUTICALS LTDRIZATRIPTAN BENZOATE USP

DMF 257642012

HETERO DRUGS LTDRIZATRIPTAN BENZOATE USP

DMF 260172012

UNICHEM LABORATORIES LTDRIZATRIPTAN BENZOATE USP

DMF 279912014

SYN-TECH CHEM AND PHARM CO LTDRIZATRIPTAN BENZOATE USP

DMF 286342014

CIPLA LTDInactiveRIZATRIPTAN BENZOATE

DMF 176332004

APOTEX PHARMACHEM INDIA PVT LTDInactiveRIZATRIPTAN BENZOATE USP

DMF 240612010

ALP PHARM BEIJING CO LTDInactiveRIZATRIPTAN BENZOATE

DMF 252292011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Oct 2, 2019	SUPPL -24	View Letter (PDF)
Dec 21, 2011	SUPPL -20	View Letter (PDF)
Dec 21, 2011	SUPPL -16	View Letter (PDF)
Dec 21, 2011	SUPPL -18	View Letter (PDF)
Dec 21, 2011	SUPPL -21	View Letter (PDF)
Dec 21, 2011	SUPPL -12	View Letter (PDF)
Aug 16, 2010	SUPPL -14	View Letter (PDF)
Apr 22, 2002	SUPPL -9	View Letter (PDF)
Nov 23, 1999	SUPPL -1	View Letter (PDF)
Jun 29, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 29, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jun 29, 1998