Meclizine hydrochloride - Generic Drug Details

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

Meclizine hydrochloride is the generic ingredient in two branded drugs marketed by Casper Pharma Llc, Invagen Pharms, Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma Usa, Bundy, Chartwell Rx, Epic Pharma Llc, Invatech, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Strides Pharma, Superpharm, UDL, Vangard, Watson Labs, Wilshire Pharms Inc, and Zydus, and is included in thirty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for meclizine hydrochloride. Thirty-six suppliers are listed for this compound.

Sponsor	Phase
Mansoura University	Phase 1/Phase 2
Hospital Federal de Bonsucesso	Phase 4
Yvonne Sada	Phase 1

Sponsor

Phase

Mansoura University

Phase 1/Phase 2

Hospital Federal de Bonsucesso

Phase 4

Yvonne Sada

Phase 1

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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
Casper Pharma Llc	ANTIVERT	meclizine hydrochloride	TABLET;ORAL	010721-001	Jan 20, 1982	AA	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Kv Pharm	MECLIZINE HYDROCHLORIDE	meclizine hydrochloride	TABLET;ORAL	085524-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pliva	MECLIZINE HYDROCHLORIDE	meclizine hydrochloride	TABLET;ORAL	088734-001	Dec 11, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Superpharm	MECLIZINE HYDROCHLORIDE	meclizine hydrochloride	TABLET;ORAL	089114-001	Aug 20, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bundy	MECLIZINE HYDROCHLORIDE	meclizine hydrochloride	TABLET;ORAL	084382-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus	MECLIZINE HYDROCHLORIDE	meclizine hydrochloride	TABLET;ORAL	213957-002	Jun 23, 2020	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Invagen Pharms	MECLIZINE HYDROCHLORIDE	meclizine hydrochloride	TABLET;ORAL	200432-003	Feb 17, 2022	AA	RX	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

US Patents:	0
Tradenames:	2
Applicants:	26
NDAs:	38
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	182
Clinical Trials:	10
Patent Applications:	6,869
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in meclizine hydrochloride?	meclizine hydrochloride excipients list
DailyMed Link:	meclizine hydrochloride at DailyMed

Drug Class	Antiemetic
Physiological Effect	Emesis Suppression