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PROMETHAZINE HYDROCHLORIDE Drug Profile
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Which patents cover Promethazine Hydrochloride, and when can generic versions of Promethazine Hydrochloride launch?
Promethazine Hydrochloride is a drug marketed by Abbott, Akorn, Am Regent, Bedford Labs, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, Xgen Pharms, Able, Cosette, Perrigo Israel, Taro, Watson Labs Inc, Amneal Pharms, Hi Tech Pharma, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Mylan, Prinston Inc, Pvt Form, Quagen, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Hi-tech Pharma Co. and is included in eighty-seven NDAs.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for PROMETHAZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 45 |
| NDAs: | 87 |
| Suppliers / Packagers: | 48 |
| Bulk Api Vendors: | 88 |
| Clinical Trials: | 45 |
| Patent Applications: | 2,115 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PROMETHAZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PROMETHAZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Phase 4 |
| Universidade Federal de Alfenas | Phase 4 |
| Kyowa Kirin | Phase 2 |
Pharmacology for PROMETHAZINE HYDROCHLORIDE
| Drug Class | Phenothiazine |
Medical Subject Heading (MeSH) Categories for PROMETHAZINE HYDROCHLORIDE
US Patents and Regulatory Information for PROMETHAZINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lannett | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 080949-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Watson Labs | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 083712-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Kv Pharm | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 085388-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Cosette | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 040428-001 | Feb 5, 2002 | AB | RX | No | Yes | 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 |
