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Procysbi is a drug marketed by Horizon Pharma Usa and is included in two NDAs. There are seventeen patents protecting this drug and one Paragraph IV challenge.
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.
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
Summary for procysbi
|Raw Ingredient (Bulk) Api Vendors:||19|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for procysbi|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for procysbi|
|What excipients (inactive ingredients) are in procysbi?||procysbi excipients list|
|DailyMed Link:||procysbi at DailyMed|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for procysbi
*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.
|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||Get Started Free||Get Started Free||Get Started Free|
|Horizon Pharma Usa||PROCYSBI||cysteamine bitartrate||CAPSULE, DELAYED RELEASE;ORAL||203389-002||Apr 30, 2013||RX||Yes||Yes||Get Started Free||Get Started Free||Get Started Free|
|Horizon Pharma Usa||PROCYSBI||cysteamine bitartrate||GRANULE, DELAYED RELEASE;ORAL||213491-002||Feb 14, 2020||RX||Yes||Yes||Get Started Free||Get Started Free||Get Started Free|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1919458||SPC/GB14/019||United Kingdom||Get Started Free||PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910|
|1919458||2014C/018||Belgium||Get Started Free||PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910|
|1919458||C01919458/01||Switzerland||Get Started Free||PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|