Skip to main content

Generic Doptelet Availability

Last updated on Oct 6, 2021.

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

DOPTELET (avatrombopag maleate - tablet;oral)

  • Manufacturer: AKARX INC
    Approval date: May 21, 2018
    Strength(s): EQ 20MG BASE [RLD]

Has a generic version of Doptelet been approved?

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

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

  • 2-Acylaminothiazole derivative or salt thereof
    Patent 7,638,536
    Issued: December 29, 2009
    Inventor(s): Sugasawa; Keizo & Watanuki; Susumu & Koga; Yuji & Nagata; Hiroshi & Obitsu; Kazuyoshi & Wakayama; Ryutaro & Hirayama; Fukushi & Suzuki; Ken-ichi
    Assignee(s): Astellas Pharma Inc.

    A 2-acylaminothiazole derivative or a pharmaceutically acceptable salt thereof having an excellent effect of proliferating human c-mpl-Ba/F3 cells and an activity of increasing platelets based on the effect of promoting the formation of megakaryocytic colonies. A compound or a pharmaceutically acceptable salt thereof useful in treating thrombocytopenia.

    Patent expiration dates:

    • May 5, 2025
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 2-acylaminothiazole derivative or salt thereof
    Patent 8,338,429
    Issued: December 25, 2012
    Inventor(s): Sugasawa; Keizo & Watanuki; Susumu & Koga; Yuji & Nagata; Hiroshi & Wakayama; Ryutaro & Hirayama; Fukushi & Suzuki; Ken-ichi
    Assignee(s): Astellas Pharma, Inc.

    A 2-acylaminothiazole derivative or a pharmaceutically acceptable salt thereof having an excellent effect of proliferating human c-mpl-Ba/F3 cells and an activity of increasing platelets based on the effect of promoting the formation of megakaryocytic colonies. A compound or a pharmaceutically acceptable salt thereof useful in treating thrombocytopenia.

    Patent expiration dates:

    • June 30, 2023
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAS HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
  • 2-acylaminothiazole derivative or salt thereof
    Patent 8,765,764
    Issued: July 1, 2014
    Assignee(s): Astellas Pharma, Inc.

    A 2-acylaminothiazole derivative or a pharmaceutically acceptable salt thereof having an excellent effect of proliferating human c-mpl-Ba/F3 cells and an activity of increasing platelets based on the effect of promoting the formation of megakaryocytic colonies. A compound or a pharmaceutically acceptable salt thereof useful in treating thrombocytopenia.

    Patent expiration dates:

    • January 15, 2023
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE USING DOPTELET
    • January 15, 2023
      ✓ 
      Patent use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE

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:

    • June 26, 2022 - TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
    • May 21, 2023 - NEW CHEMICAL ENTITY
    • June 26, 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.