SILPHEN Drug Patent Profile
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Which patents cover Silphen, and when can generic versions of Silphen launch?
Silphen is a drug marketed by Lannett Co Inc and is included in one NDA.
The generic ingredient in SILPHEN 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 Silphen
A generic version of SILPHEN was approved as diphenhydramine hydrochloride by WEST-WARD PHARMS INT on December 31st, 1969.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SILPHEN?
- What are the global sales for SILPHEN?
- What is Average Wholesale Price for SILPHEN?
Summary for SILPHEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,388 |
| DailyMed Link: | SILPHEN at DailyMed |
Recent Clinical Trials for SILPHEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | Phase 4 |
| Hospira, Inc. | Phase 4 |
| University of Pennsylvania | Phase 4 |
US Patents and Regulatory Information for SILPHEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lannett Co Inc | SILPHEN | diphenhydramine hydrochloride | SYRUP;ORAL | 072646-001 | Feb 27, 1992 | 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 |
