➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

McKesson
Dow
Colorcon
AstraZeneca
Moodys
Mallinckrodt

Last Updated: September 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213491

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 213491 describes PROCYSBI, which is a drug marketed by Horizon Pharma Usa and is included in two NDAs. There are sixteen patents protecting this drug. Additional details are available on the PROCYSBI profile page.

The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 213491
Tradename:PROCYSBI
Applicant:Horizon Pharma Usa
Ingredient:cysteamine bitartrate
Patents:11
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 213491
Generic Entry Date for 213491*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULE, DELAYED RELEASE;ORAL

*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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE, DELAYED RELEASE;ORALStrengthEQ 75MG BASE/PACKET
Approval Date:Feb 14, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 22, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Dec 22, 2020
Regulatory Exclusivity Use:UPDATE THE PRESCRIBING INFORMATION AND PATIENT LABELING WITH FINDINGS FROM STUDY RP103-08 CONDUCTED IN TREATMENT-NAIVE NEPHROPATHIC CYSTINOSIS PATIENTS TO EXPAND THE INDICATED POPULATION TO PATIENTS 1 YEAR AND OLDER
Patent:  Start TrialPatent Expiration:Aug 16, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Merck
Medtronic
McKesson
Baxter
AstraZeneca
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.