Hydroxyzine hydrochloride - Generic Drug Details
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What are the generic drug sources for hydroxyzine hydrochloride and what is the scope of freedom to operate?
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
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prinston Inc | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040580-003 | May 27, 2005 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm Inds Inc | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 040899-001 | Jun 10, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 087245-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Quantum Pharmics | HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | TABLET;ORAL | 088529-001 | Oct 22, 1985 | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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