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Last Updated: November 21, 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. Forty-six 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: 46
Raw Ingredient (Bulk) Api Vendors: 204
Clinical Trials: 33
Patent Applications: 7,009
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

SponsorPhase
Sultan Qaboos UniversityPhase 4
The S.N. Fyodorov Eye Microsurgery State InstitutionEarly Phase 1
Minia UniversityPhase 1

See all HYDROXYZINE HYDROCHLORIDE clinical trials

Pharmacology for HYDROXYZINE HYDROCHLORIDE
Drug ClassAntihistamine
Mechanism of ActionHistamine Receptor Antagonists
Anatomical Therapeutic Chemical (ATC) Classes for HYDROXYZINE HYDROCHLORIDE

US Patents and Regulatory Information for HYDROXYZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087862-001 Apr 18, 1983 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride INJECTABLE;INJECTION 087329-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Iii HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040805-002 May 29, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Usl Pharma HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 089121-001 Mar 20, 1986 DISCN 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

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