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Generic Brilinta Availability

Last updated on Mar 9, 2023.

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

BRILINTA (ticagrelor - tablet;oral)

  • Manufacturer: ASTRAZENECA
    Approval date: July 20, 2011
    Strength(s): 90MG [RLD] [AB]
  • Manufacturer: ASTRAZENECA
    Approval date: September 3, 2015
    Strength(s): 60MG [RLD]

Has a generic version of Brilinta been approved?

A generic version of Brilinta has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Brilinta and have been approved by the FDA:

ticagrelor tablet;oral

  • Manufacturer: HISUN PHARM HANGZHOU
    Approval date: January 23, 2019
    Strength(s): 90MG [AB]

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

  • Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
    Patent 10,300,065
    Issued: May 28, 2019
    Assignee(s): ASTRAZENECA AB

    The present disclosure relates to methods for reducing the rate of cardiovascular death, myocardial infarction, or stroke in a patient in recognized need thereof, comprising administering to the patient a pharmaceutical composition comprising 60 mg ticagrelor twice daily.

    Patent expiration dates:

    • January 27, 2036
      ✓ 
      Patent use: REDUCING THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION (MI), AND STROKE IN A PATIENT RECEIVING 75-100 MG ASPIRIN DAILY WITH A HISTORY OF MI BY ADMINISTERING 60 MG TICAGRELOR TWICE DAILY
    • January 27, 2036
      ✓ 
      Patent use: REDUCING THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN A PATIENT RECEIVING 75-100 MG ASPIRIN DAILY AND HAVING OR WHO HAD ACUTE CORONARY SYNDROME BY ADMINISTERING 60 MG TICAGRELOR TWICE DAILY
  • Patent 10300065*

    Patent expiration dates:

    • July 27, 2036
  • Pharmaceutical compositions
    Patent 8,425,934
    Issued: April 23, 2013
    Assignee(s): AstraZeneca AB

    The present invention relates to pharmaceutical compositions and, more particularly, to a pharmaceutical composition containing the compound {1S-[1α,2α,3β(1S*,2R*),5β]}-3-(7-{[2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol.

    Patent expiration dates:

    • April 17, 2030
      ✓ 
      Drug product
    • October 17, 2030
      ✓ 
      Pediatric exclusivity
  • Triazolo(4,5-D)pyrimidine compounds
    Patent RE46276
    Issued: January 17, 2017
    Assignee(s): AstraZeneca UK Limited

    Triazolo[4,5-d]pyrimidine compounds, their use as medicaments, compositions containing them and processes for their preparation. The compounds of the invention have the formula (I) as follows: wherein R, X and R1 through R3 are as defined in the specification.

    Patent expiration dates:

    • October 30, 2024
      ✓ 
      Patent use: REDUCTION OF THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN PATIENTS WITH A HISTORY OF MYOCARDIAL INFARCTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 30, 2024
      ✓ 
      Patent use: TREATMENT OF STROKE IN PATIENTS WITH ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 30, 2024
      ✓ 
      Patent use: TREATMENT OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 30, 2024
      ✓ 
      Patent use: TREATMENT OF MYOCARDIAL INFARCTION IN PATIENTS WITH ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 30, 2024
      ✓ 
      Patent use: REDUCTION OF THE RISK OF STROKE IN PATIENTS WITH ACUTE ISCHEMIC STROKE OR HIGH-RISK TRANSIENT ISCHEMIC ATTACK
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 30, 2024
      ✓ 
      Patent use: TREATMENT OF MYOCARDIAL INFARCTION OR STROKE IN PATIENTS WITH CORONARY ARTERY DISEASE AT HIGH RISK FOR SUCH EVENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 30, 2024
      ✓ 
      Patent use: REDUCTION OF THE RATE OF A FIRST MYOCARDIAL INFARCTION OR STROKE IN PATIENTS WITH CORONARY ARTERY DISEASE AT HIGH RISK FOR SUCH EVENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 30, 2025
      ✓ 
      Pediatric exclusivity

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:

    • May 28, 2023 - TO REDUCE THE RISK OF A FIRST MYOCARDIAL INFARCTION (MI) OR STROKE IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) AT HIGH RISK FOR SUCH EVENTS
    • November 5, 2023 - REDUCE THE RISK OF STROKE IN PATIENTS WITH ACUTE ISCHEMIC STROKE (NIH STROKE SCALE SCORE <=5) OR HIGH-RISK TRANSIENT ISCHEMIC ATTACK (TIA)
    • November 28, 2023 - PEDIATRIC EXCLUSIVITY
    • May 5, 2024 - PEDIATRIC EXCLUSIVITY
    • May 9, 2025 - INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HESTIA3
    • November 9, 2025 - PEDIATRIC EXCLUSIVITY

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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

Medical Disclaimer