Generic Nerlynx Availability
Last updated on Nov 7, 2023.
Nerlynx is a brand name of neratinib, approved by the FDA in the following formulation(s):
NERLYNX (neratinib maleate - tablet;oral)
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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 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.
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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 10,035,788
Issued: July 31, 2018
Inventor(s): Lu Qinghong & Ku Mannching Sherry & Chew Warren & Cheal Gloria & Hadfield Anthony F. & Mirmehrabi Mahmoud
Assignee(s): WYETH LLCThe 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✓
- October 15, 2028✓
- October 15, 2028✓
- October 15, 2028
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Patent 7,399,865
Issued: November 30, -0001Patent expiration dates:
- December 29, 2030✓✓
- December 29, 2030
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Patent 7,982,043
Issued: November 30, -0001Patent expiration dates:
- October 8, 2025✓
- October 8, 2025✓
- October 8, 2025✓
- October 8, 2025
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Coated tablet formulations and uses thereof
Patent 8,518,446
Issued: August 27, 2013
Inventor(s): Ashraf Muhammad & Mahmud Mainuddin & Goolcharran Chimanlall & Ghosh Krishnendu & Nagi Arwinder Singh
Assignee(s): Wyeth LLCThe present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.
Patent expiration dates:
- November 20, 2030✓✓
- November 20, 2030✓✓
- November 20, 2030✓✓
- November 20, 2030
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Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Patent 8,669,273
Issued: March 11, 2014
Inventor(s): Zacharchuk Charles Michael & Quinn Susan Elizabeth & Wang Kenneth Kuan-Yuen & Binlich Florence Marie Helene
Assignee(s): Wyeth LLCA combination of a 4-anilino-3-cyanoquinoline compound (e.g. HKI-272, SKI-606, EKB-569) and a capecitabine compound in the treatment of a neoplasm is provided. Regimens, kits, and methods for treatment of neoplasm, including breast cancer including metastatic breast cancer, and lung cancer, using this combination, optionally in combination with other anti-neoplastic agents, or immune modulators are also described.
Patent expiration dates:
- July 18, 2031✓
- July 18, 2031
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Coated tablet formulations and uses thereof
Patent 8,790,708
Issued: July 29, 2014
Inventor(s): Ashraf Muhammad & Mahmud Mainuddin & Goolcharran Chimanlall & Ghosh Krishnendu & Nagi Arwinder Singh
Assignee(s): Wyeth LLCThe present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.
Patent expiration dates:
- November 5, 2030✓✓
- November 5, 2030✓✓
- November 5, 2030✓✓
- November 5, 2030
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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
Inventor(s): Lu Quinhong & Ku Mannching Sherry & Chew Warren & Cheal Gloria & Hadfield Anthony F. & Mirmehrabi Mahmoud
Assignee(s): Wyeth LLCThe 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✓
- October 15, 2028✓
- October 15, 2028✓
- October 15, 2028
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Treatment regimen utilizing neratinib for breast cancer
Patent 9,211,291
Issued: December 15, 2015
Inventor(s): Berkenblit Anna & Binlich Florence Marie Helene & Goss Paul
Assignee(s): WYETH LLCAn 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✓
- March 24, 2030✓
- March 24, 2030
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Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Patent 9,265,784
Issued: February 23, 2016
Inventor(s): Zacharchuk Charles Michael & Quinn Susan Elizabeth & Wang Kenneth Kuan-Yuen & Binlich Florence Marie Helene
Assignee(s): WYETH LLCA combination of a 4-anilino-3-cyanoquinoline compound (e.g. HKI-272, SKI-606, EKB-569) and a capecitabine compound in the treatment of a neoplasm is provided. Regimens, kits, and methods for treatment of neoplasm, including breast cancer including metastatic breast cancer, and lung cancer, using this combination, optionally in combination with other anti-neoplastic agents, or immune modulators are also described.
Patent expiration dates:
- August 4, 2029✓
- August 4, 2029
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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
Inventor(s): Lu Quinhong & Ku Mannching Sherry & Chew Warren & Cheal Gloria & Hadfield Anthony F. & Mirmehrabi Mahmoud
Assignee(s): WYETH LLCThe 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✓
- October 15, 2028✓
- October 15, 2028✓
- October 15, 2028
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 25, 2023 - USE IN COMBINATION WITH CAPECITABINE, FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR ANTI-HER2 BASED REGIMENS IN THE METASTATIC SETTING
- June 28, 2024 - NEW DOSING REGIMEN FOR THE PREVENTION AND MANAGEMENT OF NERATINIB‐ASSOCIATED DIARRHEA
More about Nerlynx (neratinib)
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- Drug class: EGFR inhibitors
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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.
