DIPHENHYDRAMINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Diphenhydramine Hydrochloride, and what generic alternatives are available?
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, Eurohlth Intl Sarl, Hospira, Lyphomed, Micro Labs, Mylan Institutional, West-ward Pharms Int, Wyeth Ayerst, Akorn, Alpharma Us Pharms, Cumberland Swan, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication. and is included in seventy-four NDAs.
The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Thirteen 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.
Summary for DIPHENHYDRAMINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 50 |
| NDAs: | 74 |
| Finished Product Suppliers / Packagers: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 298 |
| Patent Applications: | 4,231 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DIPHENHYDRAMINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Carl Ola Landgren, MD, PhD | Phase 2 |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Phase 2 |
| Beijing Biostar Pharmaceuticals Co., Ltd. | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sun Pharm Industries | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 089488-001 | Jan 2, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Perrigo | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 083061-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |
