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TAVIST-1

NDA

CLEMASTINE FUMARATE | N020925 | HALEON US HOLDINGS LLC

1 strength0 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 2 CLEMASTINE FUMARATE Description re Suitability Petition from Pha... FDA-2023-P-4292 · 7 docket documents Pharmobedient Consulting LLC filed a suitability petition regarding clemastine fumarate, requesting a determination of the drug's suitability for inclusion in an abbreviated new drug application or generic drug product development program.	Suitability	2023-10-03	Denied	Pharmobedient Consulting LLC
Attachment 1 -Orange Book -TAVIST (Clemastine Fumarate) re Suitability Petiti... FDA-2023-P-4330 · 9 docket documents Pharmobedient Consulting, LLC filed a citizen petition regarding clemastine fumarate, the active ingredient in TAVIST, requesting a determination of suitability for abbreviated new drug application (ANDA) filing under the Orange Book regulatory framework.	Suitability	2023-10-03	Denied	Pharmobedient Consulting, LLC

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

Clinical Trials

8 trials from ClinicalTrials.gov — 1 recruiting, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)NCT02521311	Phase 2	Recruiting	University of California, San Francisco	90	2017-02-28 → 2028-08
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria NCT00481676	Phase 2	Completed	Novartis	49	2007-05 → 2009-04
To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets NCT00913549	Phase 1	Completed	Sandoz	36	1989-12 → 1990-01
Clemastine in Cardiovascular Surgery NCT03826004	N/A	Completed	Chinese Academy of Medical Sciences, Fuwai Hospital	100	2019-02-20 → 2020-01-10
Effect of Clemastine Fumarate on Color Vision in Healthy Controls NCT02613091	Phase 1	Completed	University of California, San Francisco	23	2016-04
Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis NCT02040298	Phase 2	Completed	University of California, San Francisco	50	2014-01 → 2016-04
Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis NCT01239719	Phase 3	UNKNOWN	Azidus Brasil	96	2011-03 → 2011-12
Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis NCT01125761	Phase 3	Withdrawn	Azidus Brasil	—	2010-11 → 2010-11

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

API Supply Chain1 active DMF

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

STHREE CHEMICALS PRIVATE LTDCLEMASTINE FUMARATE USP

DMF 434632026

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

Products (1)

#001 — 1.34MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 21, 1992

No patent or exclusivity listings for this strength.