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Federal Trade Commission
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Generated: December 12, 2018

DrugPatentWatch Database Preview

PROCYSBI Drug Profile

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When do Procysbi patents expire, and when can generic versions of Procysbi launch?

Procysbi is a drug marketed by Horizon Pharma Usa and is included in one NDA. There are eight patents protecting this drug.

This drug has thirty-five patent family members in twenty-five countries.

The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.

Summary for PROCYSBI
International Patents:35
US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 16
Patent Applications: 85
Formulation / Manufacturing:see details
DailyMed Link:PROCYSBI at DailyMed
Drug patent expirations by year for PROCYSBI
Pharmacology for PROCYSBI

US Patents and Regulatory Information for PROCYSBI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Horizon Pharma Usa PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for PROCYSBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000023 Germany ➤ Sign Up PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
2014 00013 Denmark ➤ Sign Up PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
4 50001-2014 Slovakia ➤ Sign Up PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
00649 Netherlands ➤ Sign Up PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
/2014 Austria ➤ Sign Up PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
0649 Netherlands ➤ Sign Up PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Cerilliant
AstraZeneca
Citi
Julphar
Medtronic
Chinese Patent Office
Boehringer Ingelheim

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