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. Fourteen 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.
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Questions you can ask:
- What is the 5 year forecast for BENADRYL?
- What are the global sales for BENADRYL?
- What is Average Wholesale Price for BENADRYL?
Summary for BENADRYL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 167 |
| Patent Applications: | 1,716 |
| DailyMed Link: | BENADRYL at DailyMed |
Recent Clinical Trials for BENADRYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 2 |
| Assertio Holdings, Inc | Phase 2 |
| Dayton Children's Hospital | N/A |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mcneil Cons | BENADRYL | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 006146-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mcneil Cons | BENADRYL | diphenhydramine hydrochloride | CAPSULE;ORAL | 005845-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mcneil Cons | BENADRYL | diphenhydramine hydrochloride | ELIXIR;ORAL | 005845-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mcneil Cons | BENADRYL PRESERVATIVE FREE | diphenhydramine hydrochloride | INJECTABLE;INJECTION | 009486-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
