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Last Updated: April 19, 2024

Hydroxyzine hydrochloride - Generic Drug Details

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What are the generic sources for hydroxyzine hydrochloride and what is the scope of patent protection?

Hydroxyzine hydrochloride is the generic ingredient in five branded drugs marketed by Baxter Hlthcare, Altana, Am Regent, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Organon Usa Inc, Pfizer, Roerig, Alpharma Us Pharms, Anima, Apozeal Pharms, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Rising, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred and four NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for hydroxyzine hydrochloride. Thirty-five suppliers are listed for this compound.

Summary for hydroxyzine hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	48
NDAs:	104
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	204
Clinical Trials:	32
Patent Applications:	7,157
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in hydroxyzine hydrochloride?	hydroxyzine hydrochloride excipients list
DailyMed Link:	hydroxyzine hydrochloride at DailyMed

Recent Clinical Trials for hydroxyzine hydrochloride

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

Sponsor	Phase
Sultan Qaboos University	Phase 4
Minia University	Phase 1
Mongi Slim Hospital	N/A

See all hydroxyzine hydrochloride clinical trials

Pharmacology for hydroxyzine hydrochloride

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists

US Patents and Regulatory Information for hydroxyzine hydrochloride

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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
Sandoz	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	085247-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	INJECTABLE;INJECTION	088185-001	Mar 31, 1983		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Usl Pharma	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	089122-001	Mar 20, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	087871-003	Dec 20, 1982	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Purepac Pharm	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	088121-001	Sep 25, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	081150-001	Mar 18, 1994		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Prinston Inc	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040580-002	May 27, 2005	AB	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

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