PROMETHAZINE HYDROCHLORIDE PLAIN Drug Patent Profile
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When do Promethazine Hydrochloride Plain patents expire, and what generic alternatives are available?
Promethazine Hydrochloride Plain is a drug marketed by Ani Pharms and is included in one NDA.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Promethazine Hydrochloride Plain
A generic version of PROMETHAZINE HYDROCHLORIDE PLAIN was approved as promethazine hydrochloride by ZYDUS PHARMS USA on November 18th, 2005.
Summary for PROMETHAZINE HYDROCHLORIDE PLAIN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 58 |
Patent Applications: | 2,254 |
Formulation / Manufacturing: | see details |
DailyMed Link: | PROMETHAZINE HYDROCHLORIDE PLAIN at DailyMed |
Recent Clinical Trials for PROMETHAZINE HYDROCHLORIDE PLAIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Trauma Center | N/A |
Oman Medical Speciality Board | Phase 3 |
Tanta University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for PROMETHAZINE HYDROCHLORIDE PLAIN
US Patents and Regulatory Information for PROMETHAZINE HYDROCHLORIDE PLAIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ani Pharms | PROMETHAZINE HYDROCHLORIDE PLAIN | promethazine hydrochloride | SYRUP;ORAL | 008381-004 | Apr 18, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ani Pharms | PROMETHAZINE HYDROCHLORIDE PLAIN | promethazine hydrochloride | SYRUP;ORAL | 008381-003 | 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 |