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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203389

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NDA 203389 describes PROCYSBI, which is a drug marketed by Horizon Pharma Usa and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the PROCYSBI profile page.

The generic ingredient in PROCYSBI is cysteamine bitartrate. There are five 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 NDA: 203389

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:5
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details

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 Raptor Therapeutics Inc. 49663-001 49663-001-06 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-001-06)
PROCYSBI
cysteamine bitartrate
CAPSULE, DELAYED RELEASE;ORAL 203389 NDA Raptor Therapeutics Inc. 49663-002 49663-002-25 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-002-25)

Summary 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:Aug 14, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Apr 30, 2020
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Aug 14, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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Serving 500+ biopharmaceutical companies globally:

Dow
Express Scripts
Accenture
Chubb
Cantor Fitzgerald
Boehringer Ingelheim
Novartis
Julphar
Merck
Fuji

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 verifification 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.

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