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Generic Ibrance Availability

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

IBRANCE (palbociclib - capsule;oral)

  • Manufacturer: PFIZER INC
    Approval date: February 3, 2015
    Strength(s): 75MG, 100MG, 125MG [RLD]

Has a generic version of Ibrance been approved?

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

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

  • 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones
    Patent 6,936,612
    Issued: August 30, 2005
    Inventor(s): Barvian; Mark & Booth; Richard John & Quin, III; John & Repine; Joseph Thomas & Sheehan; Derek J. & Toogood; Peter Laurence & Vanderwel; Scott Norman & Zhou; Hairong
    Assignee(s): Warner-Lambert Company
    The present invention provides substituted 2-aminopyridines useful in treating cell proliferative disorders. The novel compounds of the present invention are potent inhibitors of cyclin-dependent kinases 4 (cdk4)
    Patent expiration dates:
    • January 22, 2023
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      Drug substance
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      Drug product
  • 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones
    Patent 7,208,489
    Issued: April 24, 2007
    Inventor(s): Barvian; Mark & Booth; Richard John & Quin, III; John & Repine; Joseph Thomas & Sheehan; Derek J. & Toogood; Peter Laurence & Vanderwel; Scott Norman & Zhou; Hairong
    Assignee(s): Warner-Lambert Company
    The present invention provides substituted 2-aminopyridines useful in treating cell proliferative disorders. The novel compounds of the present invention are potent inhibitors of cyclin-dependent kinases 4 (cdk4)
    Patent expiration dates:
    • January 16, 2023
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      Drug substance
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      Drug product
  • 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
    Patent 7,456,168
    Issued: November 25, 2008
    Inventor(s): Barvian; Mark & Booth; Richard John & Quin, III; John & Repine; Joseph Thomas & Sheehan; Derek J. & Toogood; Peter Laurence & Vanderwel; Scott Norman & Zhou; Hairong
    Assignee(s): Warner-Lambert Company
    The present invention provides substituted 2-aminopyridines useful in treating cell proliferative disorders. The novel compounds of the present invention are potent inhibitors of cyclin-dependent kinases 4 (cdk4).
    Patent expiration dates:
    • January 16, 2023
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      Patent use: TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH LETROZOLE AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN, OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
    • January 16, 2023
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      Patent use: TREATMENT OF ER-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER IN COMBINATION WITH LETROZOLE AS INITIAL ENDOCRINE-BASED THERAPY FOR METASTATIC DISEASE IN POSTMENOPAUSAL WOMEN

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:
    • February 19, 2019 - TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY.
    • February 3, 2020 - NEW CHEMICAL ENTITY

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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