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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203389


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NDA 203389 describes PROCYSBI, which is a drug marketed by Horizon and is included in two NDAs. It is available from one supplier. There are twelve 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. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 203389
Tradename:PROCYSBI
Applicant:Horizon
Ingredient:cysteamine bitartrate
Patents:12
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203389
Generic Entry Date for 203389*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, 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.

Pharmacology for NDA: 203389
Mechanism of ActionCystine Disulfide Reduction
Suppliers and Packaging for NDA: 203389
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389 NDA Horizon Therapeutics USA, Inc. 75987-100 75987-100-04 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04)
PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389 NDA Horizon Therapeutics USA, Inc. 75987-101 75987-101-08 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Apr 30, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 22, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Dec 22, 2024
Regulatory Exclusivity Use:TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
Patent:⤷  Try a TrialPatent Expiration:Feb 16, 2037Product Flag?Substance Flag?Delist Request?Y

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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.