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TAVIST

NDA

CLEMASTINE FUMARATE | N017661 | NOVARTIS PHARMACEUTICALS CORP

3 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

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6088 · 8 docket documents Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Clemastine Fumarate Tablets in 1.34 mg and 0.67 mg strengths suitable for submission as an ANDA for prescription use, with the referenc	Suitability	2025-11-13	Denied	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Pharmobedient Consulting, LLC FDA-2024-P-0761 · 5 docket documents Pharmobedient Consulting, LLC filed this citizen petition requesting that the FDA determine whether TAVIST (Clemastine Fumarate) Tablets, 2.68 mg, approved under NDA 017661 and held by Novartis, was withdrawn from commercial distribution for safety or efficacy reasons or only for commercial consider	505(q)	2024-02-22	Granted	Pharmobedient Consulting, LLC
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 (3)

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#001 — 2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 1.34MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 1.34MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 21, 1992