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Generic Nerlynx Availability

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

NERLYNX (neratinib maleate - tablet;oral)

  • Manufacturer: PUMA BIOTECH
    Approval date: July 17, 2017
    Strength(s): EQ 40MG BASE [RLD]

Has a generic version of Nerlynx been approved?

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

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

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.

  • Substituted 3-cyanoquinolines
    Patent 6,288,082
    Issued: September 11, 2001
    Inventor(s): Wissner; Allan & Tsou; Hwei-Ru & Berger; Dan M. & Floyd, Jr.; Middleton B. & Hamann; Philip R. & Zhang; Nan & Salvati; Mark E. & Frost; Philip
    Assignee(s): American Cyanamid Company

    This invention provides compounds of formula I having the structure ##STR1## wherein G.sub.1, G.sub.2, R.sub.1, R.sub.4, Z, n, and X are defined in the specification or a pharmaceutically acceptable salt thereof which are useful as antineoplastic agents and in the treatment of polycystic kidney disease.

    Patent expiration dates:

    • September 24, 2019
      ✓ 
      Patent use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
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      Drug substance
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      Drug product
  • Protein tyrosine kinase enzyme inhibitors
    Patent 7,399,865
    Issued: July 15, 2008
    Inventor(s): Wissner; Allan & Rabindran; Sridhar Krishna & Tsou; Hwei-Ru
    Assignee(s): Wyeth

    This invention provides compounds of formula 1, having the structure wherein R1, R2, R3, R4, and R5 are described within the specification.

    Patent expiration dates:

    • December 29, 2025
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      Drug substance
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      Drug product
  • Protein tyrosine kinase enzyme inhibitors
    Patent 7,982,043
    Issued: July 19, 2011
    Inventor(s): Wissner; Allan & Rabindran; Sridhar Krishna & Tsou; Hwei-Ru
    Assignee(s): Wyeth LLC

    This invention provides compounds of formula 1, having the structure wherein R1, R2, R3, R4, and R5 are described within the specification.

    Patent expiration dates:

    • October 8, 2025
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      Patent use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
  • Coated tablet formulations and uses thereof
    Patent 8,518,446
    Issued: August 27, 2013
    Assignee(s): Wyeth LLC

    The present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.

    Patent expiration dates:

    • November 20, 2030
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      Patent use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
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      Drug product
  • Coated tablet formulations and uses thereof
    Patent 8,790,708
    Issued: July 29, 2014
    Assignee(s): Wyeth LLC

    The present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.

    Patent expiration dates:

    • November 5, 2030
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      Patent use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
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      Drug product
  • Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
    Patent 9,139,558
    Issued: September 22, 2015
    Assignee(s): Wyeth LLC

    The present invention relates to maleate salt forms of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide, methods of preparing crystalline maleate salt forms, the associated compounds, and pharmaceutical compositions containing the same. The maleate salts are useful in treating cancers, particularly those affected by kinases of the epidermal growth factor receptor family.

    Patent expiration dates:

    • October 15, 2028
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      Patent use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
  • Treatment regimen utilizing neratinib for breast cancer
    Patent 9,211,291
    Issued: December 15, 2015
    Assignee(s): WYETH LLC

    An extended regimen for treatment of HER-2/neu overexpressed/amplified cancer is described, with involves delivering a course of neratinib therapy to HER-2/neu overexpressed/amplified cancer patients following the completion of surgical and adjuvant therapy. The neratinib regimen may be continued for upwards of twelve months to five years. Also provided are pharmaceutical kits designed to facilitate compliance with the regimen.

    Patent expiration dates:

    • March 24, 2030
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      Patent use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
  • Maleate salts of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof
    Patent 9,630,946
    Issued: April 25, 2017
    Assignee(s): WYETH LLC

    The present invention relates to maleate salt forms of (E)-N-{4-[3-chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide, methods of preparing crystalline maleate salt forms, the associated compounds, and pharmaceutical compositions containing the same. The maleate salts are useful in treating cancers, particularly those affected by kinases of the epidermal growth factor receptor family.

    Patent expiration dates:

    • October 15, 2028
      ✓ 
      Patent use: EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY

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:

    • July 17, 2022 - NEW CHEMICAL ENTITY

Further information

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

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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