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Generic Akynzeo Availability

Akynzeo is a brand name of netupitant/palonosetron, approved by the FDA in the following formulation(s):

AKYNZEO (netupitant; palonosetron hydrochloride - capsule;oral)

  • Manufacturer: HELSINN HLTHCARE
    Approval date: October 10, 2014
    Strength(s): 300MG;EQ 0.5MG BASE [RLD]

Has a generic version of Akynzeo been approved?

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

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

  • 4-phenyl-pyridine derivatives
    Patent 6,297,375
    Issued: October 2, 2001
    Inventor(s): Bos; Michael & Branca; Quirico & Galley; Guido & Godel; Thierry & Hoffmann; Torsten & Hunkeler; Walter & Schnider; Patrick & Stadler; Heinz
    Assignee(s): Hoffmann-La Roche Inc.
    The compounds of the related invention are related to 4-phenyl-pyridine derivatives connected by a bridge containing oxygen or nitrogen to a phenyl derivative.
    Patent expiration dates:
    • February 22, 2020
      ✓ 
      Drug substance
  • Compositions and methods for treating centrally mediated nausea and vomiting
    Patent 8,623,826
    Issued: January 7, 2014
    Assignee(s): Helsinn Healthcare S.A.
    Provided are methods for treating nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery, comprising the co-administration of netupitant, palonosetron and dexamethasone.
    Patent expiration dates:
    • November 18, 2030
      ✓ 
      Patent use: PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
  • Compositions and methods for treating centrally mediated nausea and vomiting
    Patent 8,951,969
    Issued: February 10, 2015
    Assignee(s): Helsinn Healthcare SA
    Provided are compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.
    Patent expiration dates:
    • November 18, 2030
      ✓ 
      Drug product
  • Compositions and methods for treating centrally mediated nausea and vomiting
    Patent 9,186,357
    Issued: November 17, 2015
    Assignee(s): HELSINN HEALTHCARE SA
    Provided are compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.
    Patent expiration dates:
    • November 18, 2030
      ✓ 
      Patent use: PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
  • Compositions and methods for treating centrally mediated nausea and vomiting
    Patent 9,271,975
    Issued: March 1, 2016
    Assignee(s): HELSINN HEALTHCARE SA
    Provided are compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.
    Patent expiration dates:
    • September 9, 2031
      ✓ 
      Patent use: PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING

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 10, 2019 - 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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