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ZELNORM

NDA

TEGASEROD MALEATE | N021200 | ALFASIGMA USA INC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P. C. FDA-2018-P-4490 · 3 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that FDA refrain from approving a supplemental new drug application (sNDA) to NDA 21200 for Zelnorm (tegaserod maleate) unless the sNDA contains substantial evidence of safety and effectiveness for the proposed use in women under	505(q)	2018-11-27	Denied	Hyman, Phelps & McNamara, P. C.

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

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Preference of Tegaserod vs. PEG 3350 in Patients With Constipation NCT00171522	Phase 4	Completed	Novartis	52	2005-05 → 2005-09
A Treatment Investigational New Drug (tIND) Program of Tegaserod in Women With Irritable Bowel Syndrome With Constipation or With Chronic Idiopathic Constipation NCT00511771	—	NO_LONGER_AVAILABLE	Novartis	—	—

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ALEMBIC PHARMACEUTICALS LTDTEGASEROD MALEATE

DMF 353672020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTEGASEROD MALEATE

DMF 370102022

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

Approval Letters

10 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 2MG BASE

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 24, 2002

No patent or exclusivity listings for this strength.

#002 — EQ 6MG BASE

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 24, 2002