Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Citi
Cantor Fitzgerald
Harvard Business School
Fish and Richardson
McKinsey
US Army
Cerilliant
Medtronic

Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202872

« Back to Dashboard

NDA 202872 describes LOTEMAX, which is a drug marketed by Bausch And Lomb Inc, Bausch And Lomb, and Pharmos, and is included in four NDAs. It is available from one supplier. Additional details are available on the LOTEMAX profile page.

The generic ingredient in LOTEMAX is loteprednol etabonate. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.
Summary for 202872
Tradename:LOTEMAX
Applicant:Bausch And Lomb Inc
Ingredient:loteprednol etabonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202872
Medical Subject Heading (MeSH) Categories for 202872
Suppliers and Packaging for NDA: 202872
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872 NDA Bausch & Lomb Incorporated 24208-503 24208-503-07 1 BOTTLE in 1 CARTON (24208-503-07) > 5 g in 1 BOTTLE
LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872 NDA Bausch & Lomb Incorporated 24208-503 24208-503-48 1 BOTTLE in 1 CARTON (24208-503-48) > .5 g in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;OPHTHALMICStrength0.5%
Approval Date:Sep 28, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 20, 2021
Regulatory Exclusivity Use:REVISED LABELING TO INCORPORATE THE PEDIATRIC USE OF LOTEPREDNOL ETABONATE GEL IN PATIENTS FOR THE TREATMENT OF POSTOPERATIVE INFLAMMATION FOLLOWING OCULAR SURGERY

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Daiichi Sankyo
Express Scripts
McKesson
Medtronic
QuintilesIMS
Healthtrust
Baxter

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.