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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.
Generic Entry Opportunity Date for 213491
*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.
Profile for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||GRANULE, DELAYED RELEASE;ORAL||Strength||EQ 75MG BASE/PACKET|
|Approval Date:||Feb 14, 2020||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Jun 22, 2021|
|Regulatory Exclusivity Use:||PEDIATRIC EXCLUSIVITY|
|Regulatory Exclusivity Expiration:||Dec 22, 2020|
|Regulatory Exclusivity Use:||UPDATE THE PRESCRIBING INFORMATION AND PATIENT LABELING WITH FINDINGS FROM STUDY RP103-08 CONDUCTED IN TREATMENT-NAIVE NEPHROPATHIC CYSTINOSIS PATIENTS TO EXPAND THE INDICATED POPULATION TO PATIENTS 1 YEAR AND OLDER|
|Patent:||Start Trial||Patent Expiration:||Aug 16, 2036||Product Flag?||Substance Flag?||Delist Request?|
|Patented Use:||MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES|
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