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Last Updated: December 14, 2019

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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 ten patents protecting this drug.

This drug has forty-four patent family members in thirty countries.

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.

US ANDA Litigation and Generic Entry Outlook for Procysbi

Procysbi was eligible for patent challenges on December 31st, 1968.

Summary for PROCYSBI
International Patents:44
US Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 18
Patent Applications: 107
Formulation / Manufacturing:see details
DailyMed Link:PROCYSBI at DailyMed
Drug patent expirations by year for PROCYSBI
Pharmacology for PROCYSBI
Synonyms for PROCYSBI
(+/-)-Tartaric Acid
2-aminoethanethiol 2,3-dihydroxysuccinate
27761-19-9
AKOS024332936
AKOS032954217
BC245627
beta-Mercaptoethylamine bitartrate
beta-Mercaptoethylamine hydrogen tartrate
CHEBI:50386
CHEMBL2062263
CTK4G0224
CYSTEAMINE BITARTRATE
Cysteamine bitartrate (JAN)
D10468
EINECS 248-641-7
Ethanethiol, 2-amino-, tartrate (1:1) (salt)
FT-0696891
MCULE-1129308393
Mercaptamine bitartrate
Procysbi (TN)
QO84GZ3TST
RP103
SCHEMBL49513
UNII-QO84GZ3TST

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

Supplementary Protection Certificates for PROCYSBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1919458 194 50001-2014 Slovakia   Start Trial PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
1919458 19/2014 Austria   Start Trial PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 C 2014 012 Romania   Start Trial PRODUCT NAME: CISTEAMINABITARTRAT; NATIONAL AUTHORISATION NUMBER: EU/1/13/861; DATE OF NATIONAL AUTHORISATION: 20130906; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/861; DATE OF FIRST AUTHORISATION IN EEA: 20130906
1919458 2014C/018 Belgium   Start Trial PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910
1919458 300649 Netherlands   Start Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 122014000023 Germany   Start Trial PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
1919458 CR 2014 00013 Denmark   Start Trial PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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