BENADRYL Drug Patent Profile
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Which patents cover Benadryl, and what generic alternatives are available?
Benadryl is a drug marketed by Mcneil Cons and is included in three NDAs.
The generic ingredient in BENADRYL 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 Benadryl
A generic version of BENADRYL was approved as diphenhydramine hydrochloride by WEST-WARD PHARMS INT on December 31st, 1969.
Summary for BENADRYL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 165 |
Patent Applications: | 4,044 |
Formulation / Manufacturing: | see details |
DailyMed Link: | BENADRYL at DailyMed |
Recent Clinical Trials for BENADRYL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Overseas Pharmaceuticals, Ltd. | Phase 1 |
Guangzhou Kangqi Medical Technology Co., LTD | Phase 1 |
Lakehead University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for BENADRYL
US Patents and Regulatory Information for BENADRYL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mcneil Cons | BENADRYL | diphenhydramine hydrochloride | CAPSULE;ORAL | 005845-007 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mcneil Cons | BENADRYL | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 006146-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mcneil Cons | BENADRYL | diphenhydramine hydrochloride | CAPSULE;ORAL | 005845-001 | 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 |