PROMETHAZINE Drug Patent Profile
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When do Promethazine patents expire, and what generic alternatives are available?
Promethazine is a drug marketed by Cenci, Slate Run Pharma, Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Xttrium Labs Inc. and is included in one hundred NDAs.
The generic ingredient in PROMETHAZINE 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.
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Summary for PROMETHAZINE
| US Patents: | 0 |
| Applicants: | 48 |
| NDAs: | 100 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 58 |
| Patent Applications: | 4,185 |
| Drug Prices: | Drug price information for PROMETHAZINE |
| Drug Sales Revenues: | Drug sales revenues for PROMETHAZINE |
| DailyMed Link: | PROMETHAZINE at DailyMed |
See drug prices for PROMETHAZINE
Recent Clinical Trials for PROMETHAZINE
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 |
US Patents and Regulatory Information for PROMETHAZINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040791-001 | May 20, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Industries | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 084557-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs Inc | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 040479-001 | Jun 24, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Able | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 040449-001 | Feb 27, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pvt Form | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 083658-001 | Approved Prior to Jan 1, 1982 | 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 |
