Skip to main content

Generic Calquence Availability

Last updated on Oct 6, 2021.

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

CALQUENCE (acalabrutinib - capsule;oral)

  • Manufacturer: ASTRAZENECA
    Approval date: October 31, 2017
    Strength(s): 100MG [RLD]

Has a generic version of Calquence been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Calquence. 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: Generic Drug FAQ.

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.

  • Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
    Patent 10,167,291
    Issued: January 1, 2019
    Assignee(s): Acerta Pharma B.V.

    In some embodiments, the invention relates to crystalline solid forms, including hydrates, polymorphs, and salt forms, of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention relates to amorphous solid forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention also relates to pharmaceutical compositions containing the solid forms, and methods for treating conditions or disorders by administering to a subject a pharmaceutical composition that includes the forms, including pharmaceutical compositions and methods for overcoming the effects of acid reducing agents.

    Patent expiration dates:

    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
      ✓ 
      Drug product
  • 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
    Patent 10,239,883
    Issued: March 26, 2019
    Assignee(s): Merck Sharp & Dohme B.V.

    The present invention relates to 6-5 membered fused pyridine ring compounds according to Formula (I) or a pharmaceutically acceptable salt thereof or to pharmaceutical compositions comprising these compounds and to their use in therapy. In particular, the present invention relates to the use of 6-5 membered fused pyridine ring compounds according to Formula (I) in the treatment of Bruton's Tyrosine Kinase (Btk) mediated disorders.

    Patent expiration dates:

    • July 11, 2032
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
    • July 11, 2032
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
  • Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
    Patent 10,272,083
    Issued: April 30, 2019
    Assignee(s): ACERTA PHARMA B.V.

    Therapeutic methods of treating chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) are described. In certain embodiments, the invention includes therapeutic methods of treating CLL and SLL using a BTK inhibitor. In certain embodiments, the invention includes therapeutic methods of treating subtypes of CLL and SLL using a BTK inhibitor, including subtypes of CLL in patients sensitive to thrombosis and subtypes of CLL that increase monocytes and NK cells in peripheral blood after treatment with a BTK inhibitor. In certain embodiments, the invention includes therapeutic methods of treating CLL and SLL using a combination of a BTK inhibitor and an anti-CD20 antibody.

    Patent expiration dates:

    • January 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY
    • January 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY
    • January 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY
    • January 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB
    • January 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY
    • January 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY
    • January 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB
  • Imidazopyrazine tyrosine kinase inhibitors
    Patent 7,459,554
    Issued: December 2, 2008
    Inventor(s): Dong; Han-Qing & Foreman; Kenneth & Mulvihill; Mark Joseph & Nigro; Anthony Innocenzo & Steinig; Arno G. & Werner; Douglas & Wilkes; Robin
    Assignee(s): OSI Pharmaceuticals, Inc.

    Compounds of the formula and pharmaceutically acceptable salts thereof, wherein Q1 and R1 are defined herein, inhibit the IGF-1R enzyme and are useful for the treatment and/or prevention of various diseases and conditions that respond to treatment by inhibition of tyrosine kinases.

    Patent expiration dates:

    • November 24, 2026
      ✓ 
      Drug substance
  • 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors
    Patent 9,290,504
    Issued: March 22, 2016
    Assignee(s): Merck Sharp & Dohme B.V.

    The present invention relates to 6-5 membered fused pyridine ring compounds according to formula (I) or a pharmaceutically acceptable salt thereof or to pharmaceutical compositions comprising these compounds and to their use in therapy. In particular, the present invention relates to the use of 6-5 membered fused pyridine ring compounds according to formula I in the treatment of Brutons Tyrosine Kinase (Btk) mediated disorders.

    Patent expiration dates:

    • July 11, 2032
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 4-imidazopyridazin-1-yl-benzamides as Btk inhibitors
    Patent 9,758,524
    Issued: September 12, 2017
    Assignee(s): Merck Sharp & Dohme B.V.

    The present invention relates to 6-5 membered fused pyridine ring compounds according to Formula (I) or a pharmaceutically acceptable salt thereof or to pharmaceutical compositions comprising these compounds and to their use in therapy. In particular, the present invention relates to the use of 6-5 membered fused pyridine ring compounds according to Formula (I) in the treatment of Bruton's Tyrosine Kinase (Btk) mediated disorders.

    Patent expiration dates:

    • July 11, 2032
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
  • Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
    Patent 9,796,721
    Issued: October 24, 2017
    Assignee(s): Acerta Pharma B.V.

    In some embodiments, the invention relates to crystalline solid forms, including hydrates, polymorphs, and salt forms, of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention relates to amorphous solid forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide. In some embodiments, the invention also relates to pharmaceutical compositions containing the solid forms, and methods for treating conditions or disorders by administering to a subject a pharmaceutical composition that includes the forms, including pharmaceutical compositions and methods for overcoming the effects of acid reducing agents.

    Patent expiration dates:

    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 1, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA
      ✓ 
      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:

    • October 31, 2022 - NEW CHEMICAL ENTITY
    • November 21, 2022 - TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
    • October 31, 2024 -
    • November 21, 2026 -

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.