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Last Updated: April 25, 2024

Cyproheptadine hydrochloride - Generic Drug Details

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What are the generic drug sources for cyproheptadine hydrochloride and what is the scope of freedom to operate?

Cyproheptadine hydrochloride is the generic ingredient in two branded drugs marketed by Actavis Mid Atlantic, Chartwell Molecular, Elysium, Halsey, Lyne, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Tris Pharma Inc, Merck, Am Therap, Appco, Ascot, Beximco Pharms Usa, Chartwell Rx, Duramed Pharms Barr, Fosun Pharma, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, Rising, Strides Pharma, Superpharm, Vitarine, Watson Labs, and Zydus Pharms, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cyproheptadine hydrochloride. Twenty-three suppliers are listed for this compound.

Summary for cyproheptadine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	34
NDAs:	41
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	27
Patent Applications:	1,484
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in cyproheptadine hydrochloride?	cyproheptadine hydrochloride excipients list
DailyMed Link:	cyproheptadine hydrochloride at DailyMed

Recent Clinical Trials for cyproheptadine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bronx VA Medical Center	Phase 1
Laval University	Phase 2
Canadian Institutes of Health Research (CIHR)	Phase 2

See all cyproheptadine hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for cyproheptadine hydrochloride

Anti-Allergic Agents
Antipruritics
Gastrointestinal Agents
Histamine H1 Antagonists
Serotonin Antagonists

US Patents and Regulatory Information for cyproheptadine hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenton	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	040644-001	May 30, 2006	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duramed Pharms Barr	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	088232-001	Oct 25, 1983		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Therap	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	088798-001	Feb 15, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	086165-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lyne	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	SYRUP;ORAL	040668-001	Jun 28, 2006	AA	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	207783-001	Dec 29, 2016		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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