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Generic Procysbi Availability

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

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

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

Has a generic version of Procysbi been approved?

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.

See also: About generic drugs.

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.

  • Enterically coated cystamine, cysteamine and derivatives thereof
    Patent 8,026,284
    Issued: September 27, 2011
    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:
    • September 22, 2027
      ✓ 
      Patent use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
  • Delayed release cysteamine bead formulation, and methods of making and using same
    Patent 9,173,851
    Issued: November 3, 2015
    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
  • Enterically coated cysteamine, cystamine and derivatives thereof
    Patent 9,192,590
    Issued: November 24, 2015
    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 9,198,882
    Issued: December 1, 2015
    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
  • Delayed release cysteamine bead formulation, and methods of making and using same
    Patent 9,233,077
    Issued: January 12, 2016
    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

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:
    • April 30, 2016 - NEW DOSAGE FORM
    • August 14, 2018 - NEW PATIENT POPULATION
    • April 30, 2020 - ORPHAN DRUG EXCLUSIVITY
    • August 14, 2022 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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