Generic Procysbi Availability

Last updated on Apr 10, 2025.

Procysbi is a brand name of cysteamine, approved by the FDA in the following formulation(s):

PROCYSBI (cysteamine bitartrate - capsule, delayed release;oral)

Manufacturer: HORIZON
Approval date: April 30, 2013
Strength(s): EQ 25MG BASE ^[RLD], EQ 75MG BASE ^[RLD]

PROCYSBI (cysteamine bitartrate - granule, delayed release;oral)

Manufacturer: HORIZON
Approval date: February 14, 2020
Strength(s): EQ 75MG BASE/PACKET ^[RLD], EQ 300MG BASE/PACKET ^[RLD]

Is there a generic version of Procysbi available?

No. There is currently no therapeutically equivalent version of Procysbi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Procysbi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Methods for storing cysteamine formulations and related methods of treatment
Patent 10,143,665
Issued: December 4, 2018
Inventor(s): DesJardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- August 16, 2036
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Methods for storing cysteamine formulations and related methods of treatment
Patent 10143665*PE
Issued: December 4, 2018
Inventor(s): DesJardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- February 16, 2037
Methods for storing cysteamine formulations and related methods of treatment
Patent 10,328,037
Issued: June 25, 2019
Inventor(s): Desjardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- August 16, 2036
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Methods for storing cysteamine formulations and related methods of treatment
Patent 10328037*PE
Issued: June 25, 2019
Inventor(s): Desjardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- February 16, 2037
Methods for storing Cysteamine formulations and related methods of treatment
Patent 10,548,859
Issued: February 4, 2020
Inventor(s): Desjardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- August 16, 2036
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Methods for storing Cysteamine formulations and related methods of treatment
Patent 10548859*PE
Issued: February 4, 2020
Inventor(s): Desjardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- February 16, 2037
Methods for storing cysteamine formulations and related methods of treatment
Patent 10,905,662
Issued: February 2, 2021
Inventor(s): Desjardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- August 16, 2036
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Methods for storing cysteamine formulations and related methods of treatment
Patent 10905662*PE
Issued: February 2, 2021
Inventor(s): Desjardin Michael & Johnson Mark
Assignee(s): Horizon Orphan LLC
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Patent expiration dates:
- February 16, 2037
Enterically coated cystamine, cysteamine and derivatives thereof
Patent 8,026,284
Issued: September 27, 2011
Inventor(s): Dohil; Ranjan et al.
Assignee(s): The Regents of the University of California (Oakland, CA)
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- September 22, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Enterically coated cystamine, cysteamine and derivatives thereof
Patent 8026284*PED
Issued: September 27, 2011
Inventor(s): Dohil; Ranjan et al.
Assignee(s): The Regents of the University of California (Oakland, CA)
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- March 22, 2028
  ✓
  Pediatric exclusivity
Delayed release cysteamine bead formulation, and methods of making and using same
Patent 9,173,851
Issued: November 3, 2015
Inventor(s): Powell Kathlene & Muttavarapu Ramesh
Assignee(s): RAPTOR PHARMACEUTICALS INC.
An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.
Patent expiration dates:
- June 17, 2034
  ✓
  Drug product
Delayed release cysteamine bead formulation, and methods of making and using same
Patent 9173851*PED
Issued: November 3, 2015
Inventor(s): Powell Kathlene & Muttavarapu Ramesh
Assignee(s): RAPTOR PHARMACEUTICALS INC.
An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.
Patent expiration dates:
- December 17, 2034
  ✓
  Pediatric exclusivity
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9,192,590
Issued: November 24, 2015
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9192590*PED
Issued: November 24, 2015
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- July 26, 2027
  ✓
  Pediatric exclusivity
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9,198,882
Issued: December 1, 2015
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9198882*PED
Issued: December 1, 2015
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- July 26, 2027
  ✓
  Pediatric exclusivity
Delayed release cysteamine bead formulation, and methods of making and using same
Patent 9,233,077
Issued: January 12, 2016
Inventor(s): Powell Kathlene & Muttavarapu Ramesh
Assignee(s): RAPTOR PHARMACEUTICALS INC.
An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.
Patent expiration dates:
- June 17, 2034
  ✓
  Drug product
Delayed release cysteamine bead formulation, and methods of making and using same
Patent 9233077*PED
Issued: January 12, 2016
Inventor(s): Powell Kathlene & Muttavarapu Ramesh
Assignee(s): RAPTOR PHARMACEUTICALS INC.
An enteric-coated bead dosage form of cysteamine, and related methods of manufacture and use, are disclosed.
Patent expiration dates:
- December 17, 2034
  ✓
  Pediatric exclusivity
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9,925,156
Issued: March 27, 2018
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
  ✓
  Drug substance
  ✓
  Drug product
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
  ✓
  Drug product
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9925156*PED
Issued: March 27, 2018
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- July 26, 2027
  ✓
  Pediatric exclusivity
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9,925,157
Issued: March 27, 2018
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
  ✓
  Drug substance
  ✓
  Drug product
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
  ✓
  Drug product
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9925157*PED
Issued: March 27, 2018
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- July 26, 2027
  ✓
  Pediatric exclusivity
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9,925,158
Issued: March 27, 2018
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
  ✓
  Drug substance
  ✓
  Drug product
- January 26, 2027
  ✓
  Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
  ✓
  Drug product
Enterically coated cysteamine, cystamine and derivatives thereof
Patent 9925158*PED
Issued: March 27, 2018
Inventor(s): Dohil Ranjan & Schneider Jerry
Assignee(s): The Regents of the University of California
The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Patent expiration dates:
- July 26, 2027
  ✓
  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- December 22, 2024 - TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
- December 22, 2024 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
- June 22, 2025 - PEDIATRIC EXCLUSIVITY

More about Procysbi (cysteamine)

Patient resources

Procysbi drug information

Other brands

Cystagon

Professional resources

Other brands

Cystagon

Related treatment guides

Nephropathic Cystinosis

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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