Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N213491

Product 002
CYSTEAMINE BITARTRATE (PROCYSBI) GRANULE, DELAYED RELEASE EQ 300MG BASE/PACKET

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 8026284 09/22/2027
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 9173851 06/17/2034 DP
03/13/2020
002 9192590 01/26/2027
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 9198882 01/26/2027
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 9233077 06/17/2034 DP
03/13/2020
002 9925156 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 9925157 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 9925158 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 10143665 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 10328037 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020
002 10548859 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
03/13/2020

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
M-216UPDATE 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
COMPETITIVE GENERIC THERAPY
12/22/2020
002
M-216UPDATE 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
*PED PEDIATRIC EXCLUSIVITY
06/22/2021

 

 


View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English