Generic Kalydeco Availability

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

KALYDECO (ivacaftor - tablet;oral)

  • Manufacturer: VERTEX PHARMS
    Approval date: January 31, 2012
    Strength(s): 150MG [RLD]

Has a generic version of Kalydeco been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kalydeco. 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.

  • Modulators of ATP-binding cassette transporters
    Patent 7,495,103
    Issued: February 24, 2009
    Inventor(s): Hadida-Ruah; Sara & Hazelwood; Anna & Grootenhuis; Peter & Van Goor; Fred & Singh; Ashvani & Zhou; Jinglan & McCartney; Jason
    Assignee(s): Vertex Pharmaceuticals Incorporated
    The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
    Patent expiration dates:
    • May 20, 2027
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Modulators of ATP-binding cassette transporters
    Patent 8,324,242
    Issued: December 4, 2012
    Inventor(s): Ruah; Sara Hadida & Hazlewood; Anna & Grootenhuis; Peter D. J. & Van Goor; Fredrick & Singh; Ashvani & Zhou; Jinglan & McCartney; Jason
    Assignee(s): Vertex Pharmaceutical Incorporated
    The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
    Patent expiration dates:
    • April 18, 2027
      ✓ 
      Patent use: METHOD OF TREATING CYSTIC FIBROSIS
  • Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
    Patent 8,410,274
    Issued: April 2, 2013
    Assignee(s): Vertex Pharmaceuticals
    The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
    Patent expiration dates:
    • December 28, 2026
      ✓ 
      Drug product
  • Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
    Patent 8,754,224
    Issued: June 17, 2014
    Assignee(s): Vertex Pharmaceuticals Incorporated
    The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
    Patent expiration dates:
    • December 28, 2026
      ✓ 
      Drug substance
      ✓ 
      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:
    • January 31, 2017 -
    • January 31, 2019 -

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.
Hide
(web2)