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NDA

CYPROHEPTADINE HYDROCHLORIDE | N013220 | MERCK AND CO INC

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

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-6811 · 6 docket documents Senores Pharmaceuticals, Inc. filed a suitability petition requesting FDA guidance on whether an abbreviated new drug application (ANDA) can be submitted for a generic version of a brand-name drug product. The petition seeks clarification on regulatory pathways and requirements for demonstrating bio	Suitability	2026-06-16	Open	Senores Pharmaceuticals, Inc.
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 · 14 docket documents Senores Pharmaceuticals, Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg and 4 mg strengths suitable for submission as an ANDA, with the reference	Suitability	2025-05-16	GrantedNo FDA response document on docket	Senores Pharmaceuticals, Inc.
Citizen Petition from CorePharma, LLC FDA-2002-P-0001 · 6 docket documents CorePharma LLC requests that the FDA assign reference listed drug status to a currently marketed and approved Cyproheptadine Hydrochloride Tablets 4 mg product, asserting that Merck's Periactin, the existing RLD, is no longer available in the market as evidenced by Merck's discontinuation notice.	505(q)	2014-09-29	DeniedUnverified summary	CorePharma, LLC

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

Clinical Trials

14 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects NCT04108104	Phase 2	Completed	Kinnov Therapeutics	154	2019-11-30 → 2022-01-31
A Study of Combination Therapy in Children With ADHD NCT01940978	Phase 4	Completed	Douglas Sears	99	2014-03 → 2015-03
Mechanisms of Neuromuscular Fatigue Post Stroke NCT01688570	Early Phase 1	Completed	Medical College of Wisconsin	27	2011-08 → 2015-05
Noninvasive Markers of Functional Nausea in Children NCT03593811	Early Phase 1	Completed	Vanderbilt University Medical Center	42	2018-08-03 → 2021-04-02
Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment NCT00066248	Phase 2	Completed	University of South Florida	70	2003-06 → 2007-08
Altering Activation Patterns Post-stroke NCT02418949	N/A	Completed	Shirley Ryan AbilityLab	96	2015-11 → 2022-03-23
Molecular Markers of Neuroplasticity During Exercise in People With Incomplete Spinal Cord Injury NCT01538693	N/A	Completed	T. George Hornby	30	2011-12 → 2015-05
A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking NCT01076283	Phase 2	Completed	Brown University	14	2009-12 → 2010-05
Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders NCT02568007	Phase 4	Terminated	Medical College of Wisconsin	4	2015-12 → 2016-08
A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain NCT01675050	Phase 2	Terminated	University of Michigan	4	2012-08 → 2013-08

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain1 active DMF1 inactive

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

OLON SPACYPROHEPTADINE HYDROCHLORIDE

DMF 32931978

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveCYPROHEPTADINE HYDROCHLORIDE

DMF 173642004

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

Products (1)

#002 — 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.