Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Merck
Baxter
Medtronic
McKesson

Last Updated: October 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208552

See Plans and Pricing

« Back to Dashboard

NDA 208552 describes RHOFADE, which is a drug marketed by Aclaris and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the RHOFADE profile page.

The generic ingredient in RHOFADE is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.
Summary for 208552
Tradename:RHOFADE
Applicant:Aclaris
Ingredient:oxymetazoline hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 208552
Medical Subject Heading (MeSH) Categories for 208552
Suppliers and Packaging for NDA: 208552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552 NDA Allergan, Inc. 0023-5300 0023-5300-30 1 TUBE in 1 CARTON (0023-5300-30) > 30 g in 1 TUBE
RHOFADE oxymetazoline hydrochloride CREAM;TOPICAL 208552 NDA Allergan, Inc. 0023-5300 0023-5300-35 1 BOTTLE, PUMP in 1 CARTON (0023-5300-35) > 30 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Jan 18, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 18, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jun 11, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:ONCE DAILY TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM, WHERE THE PATIENT EXPERIENCES NO REBOUND OR WORSENING OF FACIAL ERYTHEMA POST-TREATMENT
Patent:  Start TrialPatent Expiration:May 2, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF PERSISTENT FACIAL ERYTHEMA ASSOCIATED WITH ROSACEA IN ADULTS WITH 1% OXYMETAZOLINE HYDROCHLORIDE CREAM

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
McKinsey
Baxter
McKesson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.