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Generic Sustol Availability

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

SUSTOL (granisetron - injection, extended release;subcutaneous)

  • Manufacturer: HERON THERAPS INC
    Approval date: August 9, 2016
    Strength(s): 10MG/0.4ML (10MG/0.4ML) [RLD]

Has a generic version of Sustol been approved?

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

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

  • Semi-solid delivery vehicle and pharmaceutical compositions
    Patent 6,613,355
    Issued: September 2, 2003
    Inventor(s): Steven Y.; Ng & Hui-Rong; Shen & Jorge; Heller
    Assignee(s): A.P. Pharma, Inc.
    A semi-solid delivery vehicle contains a polyorthoester and an excipient, and a semi-solid pharmaceutical composition contains an active agent and the delivery vehicle. The pharmaceutical composition may be a topical, syringable, or injectable formulation; and is suitable for local delivery of the active agent. Methods of treatment are also disclosed.
    Patent expiration dates:
    • June 28, 2021
      ✓ 
      Drug product
  • Pharmaceutical compositions using semi-solid delivery vehicle
    Patent 6,790,458
    Issued: September 14, 2004
    Inventor(s): Steven Y.; Ng & Hui-Rong; Shen & Jorge; Heller
    Assignee(s): AP Pharma Inc.
    A semi-solid delivery vehicle contains a polyorthoester and an excipient, and a semi-solid pharmaceutical composition contains an active agent and the delivery vehicle. The pharmaceutical composition may be a topical, syringable, or injectable formulation; and is suitable for local delivery of the active agent. Methods of treatment are also disclosed.
    Patent expiration dates:
    • May 11, 2021
      ✓ 
      Drug product
  • Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
    Patent 8,252,304
    Issued: August 28, 2012
    Inventor(s): Ng; Steven Y. & Shen; Hui Rong & Heller; Jorge
    Assignee(s): A. P. Pharma, Inc.
    A semi-solid delivery vehicle contains a polyorthoester and an excipient, and a semi-solid pharmaceutical composition contains an active agent and the delivery vehicle. The pharmaceutical composition may be a topical, syringable, or injectable formulation; and is suitable for local delivery of the active agent. Methods of treatment are also disclosed.
    Patent expiration dates:
    • September 28, 2024
      ✓ 
      Drug product
  • Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron
    Patent 8,252,305
    Issued: August 28, 2012
    Inventor(s): Ng; Steven Y. & Shen; Hui Rong & Heller; Jorge
    Assignee(s): A.P. Pharma
    A semi-solid delivery vehicle contains a polyorthoester and an excipient, and a semi-solid pharmaceutical composition contains an active agent and the delivery vehicle. The pharmaceutical composition may be a topical, syringable, or injectable formulation; and is suitable for local delivery of the active agent. Methods of treatment are also disclosed.
    Patent expiration dates:
    • September 28, 2024
  • Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
    Patent 8,715,710
    Issued: May 6, 2014
    Assignee(s): Heron Therapeutics, Inc.
    A semi-solid delivery vehicle contains a polyorthoester and an excipient, and a semi-solid pharmaceutical composition contains an active agent and the delivery vehicle. The pharmaceutical composition may be a topical, syringable, or injectable formulation; and is suitable for local delivery of the active agent. Methods of treatment are also disclosed.
    Patent expiration dates:
    • September 28, 2024
      ✓ 
      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:
    • August 9, 2019 - NEW DOSAGE FORM

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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