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

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 207987


✉ Email this page to a colleague

« Back to Dashboard


NDA 207987 describes ABLYSINOL, which is a drug marketed by Bpi Labs and is included in one NDA. It is available from one supplier. Additional details are available on the ABLYSINOL profile page.

The generic ingredient in ABLYSINOL is alcohol. There are forty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alcohol profile page.
Summary for 207987
Tradename:ABLYSINOL
Applicant:Bpi Labs
Ingredient:alcohol
Patents:0
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207987
Generic Entry Date for 207987*:
Constraining patent/regulatory exclusivity:
INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY
Dosage:
SOLUTION;INTRA-ARTERIAL

*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.

Suppliers and Packaging for NDA: 207987
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABLYSINOL alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA BPI Labs, LLC 54288-105 54288-105-10 10 AMPULE in 1 CARTON (54288-105-10) / 1 mL in 1 AMPULE (54288-105-01)
ABLYSINOL alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA BPI Labs, LLC 54288-105 54288-105-15 10 AMPULE in 1 CARTON (54288-105-15) / 5 mL in 1 AMPULE (54288-105-02)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRA-ARTERIALStrength99% (1ML)
Approval Date:Jun 21, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2025
Regulatory Exclusivity Use:INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRA-ARTERIALStrength99% (5ML)
Approval Date:Jun 21, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2025
Regulatory Exclusivity Use:INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY

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.