DIPHENHYDRAMINE Drug Patent Profile
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When do Diphenhydramine patents expire, and what generic alternatives are available?
Diphenhydramine 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, Annora Pharma, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Avet Lifesciences, Bel Mar, Dr Reddys, Gland, Hikma, Hospira, Lyphomed, Micro Labs, Pharmobedient, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Sciegen Pharms, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication. and is included in seventy-nine NDAs.
The generic ingredient in DIPHENHYDRAMINE is diphenhydramine hydrochloride. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diphenhydramine
A generic version of DIPHENHYDRAMINE was approved as diphenhydramine hydrochloride by WEST-WARD PHARMS INT on December 31st, 1969.
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Questions you can ask:
- What is the 5 year forecast for DIPHENHYDRAMINE?
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- What is Average Wholesale Price for DIPHENHYDRAMINE?
Summary for DIPHENHYDRAMINE
| US Patents: | 0 |
| Applicants: | 53 |
| NDAs: | 79 |
| Drug Prices: | Drug price information for DIPHENHYDRAMINE |
| DailyMed Link: | DIPHENHYDRAMINE at DailyMed |
US Patents and Regulatory Information for DIPHENHYDRAMINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avet Lifesciences | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 205336-001 | Jun 24, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm Industries | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 089488-001 | Jan 2, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Perrigo | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | CAPSULE;ORAL | 083061-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Wyeth Ayerst | DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 080577-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 |
