➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School

Last Updated: September 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209311

Email this page to a colleague

« Back to Dashboard

NDA 209311 describes JORNAY PM, which is a drug marketed by Ironshore Pharms and is included in one NDA. There are thirteen patents protecting this drug. Additional details are available on the JORNAY PM profile page.

The generic ingredient in JORNAY PM is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 209311
Tradename:JORNAY PM
Applicant:Ironshore Pharms
Ingredient:methylphenidate hydrochloride
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Aug 8, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 8, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Free Forever TrialPatent Expiration:Mar 23, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Mar 23, 2032Product Flag?Substance Flag?Delist Request?

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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.