You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 22, 2024

Details for New Drug Application (NDA): 209963


✉ Email this page to a colleague

« Back to Dashboard


NDA 209963 describes GOPRELTO, which is a drug marketed by Noden Pharma and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug. Additional details are available on the GOPRELTO profile page.

The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cocaine hydrochloride profile page.
Summary for 209963
Tradename:GOPRELTO
Applicant:Noden Pharma
Ingredient:cocaine hydrochloride
Patents:12
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209963
Generic Entry Date for 209963*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;NASAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for 209963
Suppliers and Packaging for NDA: 209963
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963 NDA Genus Lifesciences Inc. 64950-359 64950-359-04 1 BOTTLE, GLASS in 1 CARTON (64950-359-04) / 4 mL in 1 BOTTLE, GLASS
GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963 NDA AUTHORIZED GENERIC Genus Lifesciences Inc. 64950-362 64950-362-04 1 BOTTLE, GLASS in 1 CARTON (64950-362-04) / 4 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;NASALStrength4%
Approval Date:Dec 14, 2017TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 7, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING A LOCAL ANESTHETIC PRIOR TO PERFORMING A DIAGNOSTIC OR SURGICAL PROCEDURE ON A SUBJECT WITH HEPATIC OR RENAL IMPAIRMENT
Patent:⤷  Sign UpPatent Expiration:Feb 7, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA PRIOR TO PERFORMING A PROCEDURE ON, THROUGH, OR ADJACENT TO THE MUCOUS MEMBRANES
Patent:⤷  Sign UpPatent Expiration:Feb 7, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES

Complete Access Available with Subscription

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

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 verification 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.