CYPROHEPTADINE HYDROCHLORIDE Drug Patent Profile

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Cyproheptadine Hydrochloride is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Elysium, Halsey, Lyne, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Tris Pharma Inc, Am Therap, Appco, Ascot, Beximco Pharms Usa, Chartwell Rx, Duramed Pharms Barr, 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 thirty-nine NDAs.

The generic ingredient in CYPROHEPTADINE HYDROCHLORIDE is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

A generic version of CYPROHEPTADINE HYDROCHLORIDE was approved as cyproheptadine hydrochloride by CHARTWELL RX on May 26^th, 1983.

US Patents:	0
Applicants:	32
NDAs:	39
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	29
Patent Applications:	1,026
DailyMed Link:	CYPROHEPTADINE HYDROCHLORIDE at DailyMed

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

Sponsor	Phase
Kinnov Therapeutics	Phase 1
Corey Hawes	Phase 2/Phase 3
National Center for Advancing Translational Sciences (NCATS)	Phase 2/Phase 3

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

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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
Strides Pharma	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	087129-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	088205-001	Jul 26, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	209172-001	Apr 11, 2018	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Quagen	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	212491-001	Feb 24, 2021	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Mid Atlantic	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	SYRUP;ORAL	086833-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Duramed Pharms Barr	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	088232-001	Oct 25, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mountain	CYPROHEPTADINE HYDROCHLORIDE	cyproheptadine hydrochloride	TABLET;ORAL	040537-001	Sep 30, 2003	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration