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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Medtronic
Chinese Patent Office
Johnson and Johnson
Dow
Fuji
Harvard Business School
AstraZeneca
Cantor Fitzgerald

Generated: June 21, 2018

DrugPatentWatch Database Preview

PROCYSBI Drug Profile

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When do Procysbi patents expire, and what generic alternatives are available?

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 five 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: 17
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
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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Non-Orange Book US Patents for PROCYSBI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,795,578 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
8,129,433 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
9,814,689 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
9,750,708 Enterically coated cysteamine, cystamine and derivatives thereof ➤ Sign Up
Patent No. Title Estimated Patent 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
0649 Netherlands ➤ Sign Up PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
AstraZeneca
Cantor Fitzgerald
Boehringer Ingelheim
Colorcon
Healthtrust
Teva
Fish and Richardson
McKinsey

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