HYDROXYZINE HYDROCHLORIDE Drug Patent Profile
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When do Hydroxyzine Hydrochloride patents expire, and what generic alternatives are available?
Hydroxyzine Hydrochloride is a drug marketed by Altana, Am Regent, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, 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 NDAs.
The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Hydroxyzine Hydrochloride
A generic version of HYDROXYZINE HYDROCHLORIDE was approved as hydroxyzine hydrochloride by CHARTWELL RX on April 12th, 1982.
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Summary for HYDROXYZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 45 |
| NDAs: | 100 |
| Finished Product Suppliers / Packagers: | 46 |
| Raw Ingredient (Bulk) Api Vendors: | 204 |
| Clinical Trials: | 33 |
| Patent Applications: | 4,218 |
| 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 |
| The S.N. Fyodorov Eye Microsurgery State Institution | Early Phase 1 |
| Minia University | Phase 1 |
Pharmacology for HYDROXYZINE HYDROCHLORIDE
| Drug Class | Antihistamine |
| Mechanism of Action | Histamine 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ivax Pharms | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 087410-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Quantum Pharmics | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 088551-001 | Oct 22, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Actavis Elizabeth | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 089071-001 | Jul 22, 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 |
