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HYDROXYZINE HYDROCHLORIDE Drug Profile
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» See Plans and PricingWhen do Hydroxyzine Hydrochloride patents expire, and what generic alternatives are available?
Hydroxyzine Hydrochloride is a drug marketed by Altana, Baxter Hlthcare, Dr Reddys, Fresenius Kabi Usa, Hospira, Luitpold, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Alpharma Us Pharms, Anima, Hi Tech Pharma, Kv Pharm, Lannett Co Inc, Torrent, Vintage Pharms, Wockhardt Bio Ag, Able, Actavis Elizabeth, Amneal Pharm, Aurolife Pharma Llc, Eci Pharms Llc, Epic Pharma Llc, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Mylan, Northstar Hlthcare, Nuvo Pharm, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Usl Pharma, and Vintage. and is included in one hundred and three NDAs.
The generic ingredient in HYDROXYZINE HYDROCHLORIDE is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Hydroxyzine Hydrochloride
A generic version of HYDROXYZINE HYDROCHLORIDE was approved as hydroxyzine hydrochloride by WOCKHARDT BIO AG on April 12th, 1982.
Summary for HYDROXYZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 46 |
| NDAs: | 103 |
| Suppliers / Packagers: | 35 |
| Bulk Api Vendors: | 143 |
| Clinical Trials: | 28 |
| Patent Applications: | 4,392 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | HYDROXYZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for HYDROXYZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 4 |
| Istanbul Medeniyet University | Phase 4 |
| University of Washington | Phase 4 |
Pharmacology for HYDROXYZINE HYDROCHLORIDE
| Drug Class | Antihistamine |
| Mechanism of Action | Histamine Receptor Antagonists |
Synonyms for HYDROXYZINE HYDROCHLORIDE
| (+-)-2-(2-(4-(p-Chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol dihydrochloride |
| (+/-)-2-(2-{4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl}ethoxy)ethanol hydrochloride |
| 0635AC |
| 1-(4-Chloro-alpha-phenylbenzyl)-4-((2-(2-hydroxyethoxy)ethyl)piperazine) |
| 1-(p-Chloro-.alpha.-phenylbenzyl)-4-(2-((2-hydroxyethoxy)ethyl)piperazine |
| 1-(p-Chloro-.alpha.-phenylbenzyl)-4-[2-[(2-hydroxyethoxy)ethyl]piperazine |
| 1-(p-Chloro-alpha-phenylbenzyl)-4-(2-(2-hydroxyethoxy)ethyl)piperazine |
| 1-(p-Chloro-alpha-phenylbenzyl)-4-(2-hydroxyethoxyethyl)piperazine |
| 1-(p-Chlorobenzhydryl)-4-(2-(2-hydroxyethoxy)ethyl)diethylenediamine |
| 1-(p-Chlorobenzhydryl)-4-(2-(2-hydroxyethoxy)ethyl)diethylenediamine hydrochloride |
| 1-(p-Chlorobenzhydryl)-4-(2-(2-hydroxyethoxy)ethyl)piperazine |
| 1-(p-Chlorobenzhydryl)-4-[2-(2-hydroxyethoxy)ethyl]diethylenediamine |
| 1-(p-Chlorobenzhydryl)-4-[2-(2-hydroxyethoxy)ethyl]piperazine |
| 1-(p-Chlorodiphenylmethyl)-4-(2-(2-hydroxyethoxy)ethyl)piperazine |
| 1-(p-Chlorodiphenylmethyl)-4-[2-(2-hydroxyethoxy)ethyl]piperazine |
| 1244-76-4 |
| 14729-22-7 |
| 163837-38-5 |
| 192H203 |
| 2-(2-(4-((4-chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)ethan-1-ol dihydrochloride |
| 2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)ethanol |
| 2-(2-(4-((4-Chlorophenyl)(phenyl)methyl)piperazin-1-yl)ethoxy)ethanol dihydrochloride |
| 2-(2-(4-((4-Chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)ethanol |
| 2-(2-(4-((4-Chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)ethanol hydrochloride |
| 2-(2-(4-(p-Chloro-.alpha.-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol |
| 2-(2-(4-(p-Chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol |
| 2-(2-(4-(p-Chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol dihydrochloride |
| 2-(2-(4-[(4-Chlorophenyl)(phenyl)methyl]-1-piperazinyl)ethoxy)ethanol # |
| 2-(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)ethan-1-ol |
| 2-(2-{4-[(4-Chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)ethan-1-ol--hydrogen chloride (1/2) |
| 2-(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)ethanol |
| 2-(2-{4-[(4-chlorophenyl)phenylmethyl]piperazinyl}ethoxy)ethan-1-ol |
| 2-[(2-{4-[(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethyl)oxy]ethanol |
| 2-[2-[4-(p-Chloro-.alpha.-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol |
| 2-[2-[4-[(4-chlorophenyl)-phenyl-methyl]piperazin-1-yl]ethoxy]ethanol |
| 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol;dihydrochloride |
| 2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]ethanol hydrochloride |
| 2192-20-3 |
| 24155-EP2275420A1 |
| 24155-EP2295409A1 |
| 24155-EP2298764A1 |
| 24155-EP2298765A1 |
| 24155-EP2314590A1 |
| 242H772 |
| 5-23-01-00462 (Beilstein Handbook Reference) |
| 68-88-2 |
| AB00053485 |
| AB00053485_24 |
| AB00053485_25 |
| AB0005753 |
| AC-8086 |
| AI3-50162 |
| AK-54930 |
| AKOS003334349 |
| AKOS015846478 |
| Alamon |
| ANOMHKZSQFYSBR-UHFFFAOYSA-N |
| ANW-45296 |
| API0002955 |
| API0004808 |
| Arcanax |
| Atara |
| Atarax |
| Atarax (Salt/Mix) |
| Atarax (TN) |
| Atarax base |
| Atarax dihydrochloride |
| Ataraxoid |
| Ataraxoid dihydrochloride |
| Atarazoid |
| Atarox |
| Atazina |
| Aterax |
| Atranine A |
| AX8032687 |
| BBL034752 |
| BCP08800 |
| BDBM22875 |
| BPBio1_000228 |
| BRD-A62428732-096-02-6 |
| BRD-A62428732-300-03-0 |
| BRN 0321392 |
| BSPBio_000206 |
| C07045 |
| C21H27ClN2O2 |
| C21H27ClN2O2.2HCl |
| C21H27ClN2O2.ClH |
| C21H29Cl3N2O2 |
| CAS-1244-76-4 |
| CAS-68-88-2 |
| CCG-220133 |
| CHEBI:5818 |
| CHEBI:5819 |
| CHEMBL1201007 |
| CHEMBL3186993 |
| CHEMBL896 |
| CPD001496937 |
| CS-2650 |
| CS-2651 |
| CTK8B4497 |
| CTK8G0241 |
| CTK8G7211 |
| D00672 |
| D08054 |
| DB-049942 |
| DB00557 |
| Deinait |
| Dichlorhydrate de 1-p.chlorbenzhydryl-4-(2-(2-hydroxyethoxy)ethyl)piperazine |
| Dichlorhydrate de 1-p.chlorbenzhydryl-4-(2-(2-hydroxyethoxy)ethyl)piperazine [French] |
| Disron |
| Disron (Salt/Mix) |
| DSSTox_CID_27530 |
| DSSTox_CID_3137 |
| DSSTox_GSID_23137 |
| DSSTox_GSID_47530 |
| DSSTox_RID_76887 |
| DSSTox_RID_82400 |
| DTXSID2040737 |
| DTXSID5047530 |
| DTXSID8023137 |
| Durrax |
| Durrax (Salt/Mix) |
| EINECS 200-693-1 |
| EINECS 214-989-3 |
| EINECS 218-586-3 |
| Equipoise |
| ETH012 |
| Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)- |
| Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)- (9CI) |
| Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, dihydrochloride |
| Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, dihydrochloride, (+-)- |
| Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, hydrochloride (1:2) |
| Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)- |
| Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, dihydrochloride |
| Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, hydrochloride |
| Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, monohydrochloride |
| Ethanol, 2-[2-[4-(p-chloro-.alpha.-phenylbenzyl)-1-piperazinyl]ethoxy]- |
| Ethanol, 2-[2-[4-(p-chloro-phenylbenzyl)-1-piperazinyl]ethoxy]- |
| Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]- |
| Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, dihydrochloride |
| Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-, hydrochloride (1:2) |
| Ethanol, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]-,dihydrochloride |
| Ethanol,2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]- |
| FT-0658716 |
| FT-0670239 |
| GTPL7199 |
| H965 |
| Hidroxizina |
| Hidroxizina [INN-Spanish] |
| HMS1568K08 |
| HMS3604B10 |
| HS-0097 |
| HSDB 3098 |
| HY-B0548 |
| HY-B0548A |
| Hychotine |
| Hydroksyzyny |
| Hydroksyzyny [Polish] |
| Hydroxine |
| Hydroxizine |
| HYDROXIZINE CHLORIDE |
| Hydroxizinum |
| Hydroxycine |
| Hydroxyzin |
| hydroxyzin hydrochloride |
| hydroxyzine |
| Hydroxyzine (dihydrochloride) |
| Hydroxyzine (INN) |
| Hydroxyzine [INN:BAN] |
| Hydroxyzine 2HCl |
| Hydroxyzine base |
| Hydroxyzine dihydrochloride |
| Hydroxyzine dihydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Hydroxyzine dihydrochloride, >=98% |
| Hydroxyzine Dihydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
| Hydroxyzine hydrochloride (JP17/USP) |
| Hydroxyzine hydrochloride [USAN] |
| Hydroxyzine hydrochloride [USP:JAN] |
| Hydroxyzine Hydrochloride 1.0 mg/ml in Methanol (as free base) |
| Hydroxyzine hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Hydroxyzine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Hydroxyzine Hydrochloride,(S) |
| Hydroxyzine monohydrochloride |
| Hydroxyzine pound>>NSC 169188 pound>>U.C.B 4492 |
| HYDROXYZINE TRANQUIZINE |
| hydroxyzine-2hcl |
| Hydroxyzine, (R) |
| Hydroxyzine(dihydrochloride) |
| Hydroxyzinum |
| Hydroxyzinum [INN-Latin] |
| Hydroxyzyne |
| Idrossizina |
| Idrossizina [DCIT] |
| IPSVAUIEEPSJRZ-UHFFFAOYSA-N |
| KS-000019VL |
| KS-00001F80 |
| L000930 |
| LS-66601 |
| LS-66602 |
| LS-66604 |
| Marax |
| Marex (TN) |
| MFCD00058200 |
| MLS000028602 |
| MLS002222192 |
| MRF-0000015 |
| N-(4-Chlorobenzhydryl)-N'-(hydroxyethoxyethyl)piperazine |
| N-(4-Chlorobenzhydryl)-N'-(hydroxyethyloxyethyl)piperazine |
| NCGC00018255-02 |
| NCGC00018255-03 |
| NCGC00018255-04 |
| NCGC00018255-06 |
| NCGC00021152-06 |
| NCGC00089816-02 |
| NCGC00089816-03 |
| NCGC00180974-01 |
| NCGC00256629-01 |
| neo-Calma |
| Neurolax |
| Neurozina |
| Nevrolaks |
| NP 212 |
| NSC 169188 |
| NSC-169188 |
| NSC169188 |
| Opera_ID_1515 |
| Orgatrax |
| Pamazone |
| Parenteral |
| Paxistil |
| Placidol |
| Plaxidol |
| Prestwick_272 |
| Prestwick0_000133 |
| Prestwick1_000133 |
| Prestwick2_000133 |
| Prestwick3_000133 |
| Q27106898 |
| Q27275377 |
| Q421937 |
| Quiess |
| QYS |
| s4026 |
| SAM002589941 |
| SCHEMBL41448 |
| SCHEMBL4491 |
| SCHEMBL491323 |
| SMR000058737 |
| SPBio_002145 |
| SR-01000003137 |
| SR-01000003137-2 |
| ST059726 |
| ST2403814 |
| STL417960 |
| SW196577-3 |
| TC-063555 |
| Tox21_113569 |
| Tox21_113569_1 |
| Tox21_302563 |
| Tran-Q |
| Tran-Q dihydrochloride |
| Tranquizine |
| Tranquizine dihydrochloride |
| Traquizine |
| U.C.B 4492 |
| U.CB 4492 |
| UCB 4492 |
| UCB 492 |
| UCB-4492 |
| Vesparaz-Wirkstoff |
| Vistaject |
| Vistarex |
| Vistaril |
| Vistaril (Salt/Mix) |
| Vistaril (TN) |
| Vistaril Parenteral |
| Vistaril steraject |
| Vistazine |
| VU0239818-5 |
| W-107513 |
| W0041 |
| WLN: T6N DNTJ AYR&R D6& D2O2Q |
| ZQDWXGKKHFNSQK-UHFFFAOYSA-N |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kv Pharm | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 087820-001 | Jun 23, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Quantum Pharmics | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 088551-001 | Oct 22, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Actavis Elizabeth | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 089071-001 | Jul 22, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hi Tech Pharma | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | SYRUP;ORAL | 040010-001 | Oct 28, 1994 | AA | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Northstar Hlthcare | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040840-001 | Mar 31, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
