DIPHENHYDRAMINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Diphenhydramine Hydrochloride, and when can generic versions of Diphenhydramine Hydrochloride launch?
Diphenhydramine Hydrochloride is a drug marketed by Alra, Anabolic, Elkins Sinn, Fosun Pharma, Halsey, Heather, Heritage Pharma, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Bel Mar, Dr Reddys, Gland Pharma Ltd, Hikma, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms Inc, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication. and is included in seventy-five NDAs.
The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diphenhydramine Hydrochloride
A generic version of DIPHENHYDRAMINE HYDROCHLORIDE was approved as diphenhydramine hydrochloride by WEST-WARD PHARMS INT on December 31st, 1969.
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Questions you can ask:
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Summary for DIPHENHYDRAMINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 51 |
| NDAs: | 75 |
| Finished Product Suppliers / Packagers: | 14 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 304 |
| DailyMed Link: | DIPHENHYDRAMINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Phase 1 |
| Washington University School of Medicine | Phase 2 |
| Assertio Holdings, Inc | Phase 2 |
Pharmacology for DIPHENHYDRAMINE HYDROCHLORIDE
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for DIPHENHYDRAMINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DIPHENHYDRAMINE HYDROCHLORIDE
US Patents and Regulatory Information for DIPHENHYDRAMINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 080873-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Industries | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 089488-001 | Jan 2, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Perrigo | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 083061-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abraxis Pharm | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 080586-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Vangard | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 088034-001 | Oct 27, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Kv Pharm | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | ELIXIR;ORAL | 085621-001 | 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 |
