ATARAX Drug Patent Profile
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Which patents cover Atarax, and what generic alternatives are available?
Atarax is a drug marketed by Roerig and Pfizer and is included in two NDAs.
The generic ingredient in ATARAX 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Atarax
A generic version of ATARAX was approved as hydroxyzine hydrochloride by CHARTWELL RX on April 12th, 1982.
Summary for ATARAX
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,127 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ATARAX at DailyMed |
Recent Clinical Trials for ATARAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sultan Qaboos University | Phase 4 |
| Bnai Zion Medical Center | N/A |
| University Hospital, Clermont-Ferrand | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ATARAX
US Patents and Regulatory Information for ATARAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Roerig | ATARAX | hydroxyzine hydrochloride | SYRUP;ORAL | 010485-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | ATARAX | hydroxyzine hydrochloride | TABLET;ORAL | 010392-006 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | ATARAX | hydroxyzine hydrochloride | TABLET;ORAL | 010392-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | ATARAX | hydroxyzine hydrochloride | TABLET;ORAL | 010392-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | ATARAX | hydroxyzine hydrochloride | TABLET;ORAL | 010392-005 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
