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PROMETHAZINE HYDROCHLORIDE Drug Patent 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, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Mylan, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, and Ani Pharms. and is included in eighty-nine NDAs.
The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Three 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: | 43 |
| NDAs: | 89 |
| Finished Product Suppliers / Packagers: | 50 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 54 |
| Patent Applications: | 2,258 |
| 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 |
|---|---|
| Beth Israel Deaconess Medical Center | Phase 4 |
| University of Florida | Phase 4 |
| University of Bern | Phase 4 |
Pharmacology for PROMETHAZINE HYDROCHLORIDE
| Drug Class | Phenothiazine |
Medical Subject Heading (MeSH) Categories for PROMETHAZINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes 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 | 080949-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Watson Labs | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 083401-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Kv Pharm | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 085388-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Cosette | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 040428-001 | Feb 5, 2002 | AB | RX | No | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
