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Last Updated: January 19, 2021

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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 two NDAs. There are sixteen patents protecting this drug.

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

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

US ANDA Litigation and Generic Entry Outlook for Procysbi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 17, 2034. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for PROCYSBI
Drug Prices for PROCYSBI

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Generic Entry Opportunity Date for PROCYSBI
Generic Entry Dates for PROCYSBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL
Generic Entry Dates for PROCYSBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE, 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.

Paragraph IV (Patent) Challenges for PROCYSBI
Tradename Dosage Ingredient NDA Submissiondate
PROCYSBI CAPSULE, DELAYED RELEASE;ORAL cysteamine bitartrate 203389 2020-05-11

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 GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No   Start Trial   Start Trial Y   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 GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No   Start Trial   Start Trial   Start Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes   Start Trial   Start Trial   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 19/2014 Austria   Start Trial PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 CR 2014 00013 Denmark   Start Trial PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
1919458 122014000023 Germany   Start Trial PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
1919458 300649 Netherlands   Start Trial PRODUCT NAME: CYSTEAMINE; 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 C01919458/01 Switzerland   Start Trial PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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