Generic Tagrisso Availability

Last updated on Apr 10, 2025.

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

TAGRISSO (osimertinib mesylate - tablet;oral)

• Manufacturer: ASTRAZENECA
  Approval date: November 13, 2015
  Strength(s): EQ 40MG BASE ^[RLD], EQ 80MG BASE ^[RLD]

Is there a generic version of Tagrisso available?

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

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

• Pharmaceutical compositions comprising AZD9291
  Patent 10,183,020
  Issued: January 22, 2019
  Inventor(s): Finnie Cindy & Raw Steven Anthony & Wilson David
  Assignee(s): AstraZeneca AB
  

  The present invention relates to pharmaceutical compositions suitable for oral administration, and more particularly to pharmaceutical compositions, including pharmaceutical tablet compositions, containing N-(2-{2-dimethylaminoethyl-methyl-amino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide (“AZD9291”) or a pharmaceutically acceptable salt thereof, wherein such compositions comprise a certain amount of microcrystalline cellulose and at least one other pharmaceutical diluent.

  Patent expiration dates:

  • January 2, 2035
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
    ✓ 
    Drug product
  • January 2, 2035
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
    ✓ 
    Drug product
  • January 2, 2035
    
    ✓ 
    Patent use: ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
    ✓ 
    Drug product
  • January 2, 2035
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY
    ✓ 
    Drug product
  • January 2, 2035
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE (STAGE III) NSCLC WHOSE DISEASE HAS NOT PROGRESSED DURING OR FOLLOWING PLATINUM-BASED CHEMORADIATION THERAPY AND WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS
    ✓ 
    Drug product
• 2-(2,4,5-substituted-anilino)pyrimidine compounds
  Patent 11,524,951
  Issued: December 13, 2022
  Inventor(s): Butterworth Sam & Finlay Maurice Raymond Verschoyle & Ward Richard Andrew & Redfearn Heather Marie & Kadambar Vasantha Krishna & Chintakuntla Chandrasekhara Reddy & Murugan Andiappan & Chuaqui Claudio Edmundo
  Assignee(s): AstraZeneca AB
  

  The present invention relates to certain 2-(2,4,5-substituted-anilino)pyrimidine compounds and pharmaceutically acceptable salts thereof which may be useful in the treatment or prevention of a disease or medical condition mediated through certain mutated forms of epidermal growth factor receptor (for example the L858R activating mutant, the Exon19 deletion activating mutant and the T790M resistance mutant). Such compounds and salts thereof may be useful in the treatment or prevention of a number of different cancers. The invention also relates to pharmaceutical compositions comprising said compounds and salts thereof, especially useful polymorphic forms of these compounds and salts, intermediates useful in the manufacture of said compounds and to methods of treatment of diseases mediated by various different forms of EGFR using said compounds and salts thereof.

  Patent expiration dates:

  • July 25, 2032
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
• 2-(2,4,5-substituted-anilino) pyrimidine compounds
  Patent 8,946,235
  Issued: February 3, 2015
  Inventor(s): Butterworth Sam & Finlay Maurice Raymond Verschoyle & Ward Richard Andrew & Redfearn Heather Marie
  Assignee(s): AstraZeneca AB
  

  The present invention relates to certain 2-(2,4,5-substituted-anilino)pyrimidine compounds and pharmaceutically acceptable salts thereof which may be useful in the treatment or prevention of a disease or medical condition mediated through certain mutated forms of epidermal growth factor receptor (for example the L858R activating mutant, the Exon19 deletion activating mutant and the T790M resistance mutant). Such compounds and salts thereof may be useful in the treatment or prevention of a number of different cancers. The invention also relates to pharmaceutical compositions comprising said compounds and salts thereof, especially useful polymorphic forms of these compounds and salts, intermediates useful in the manufacture of said compounds and to methods of treatment of diseases mediated by various different forms of EGFR using such compounds and salts thereof.

  Patent expiration dates:

  • August 8, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • August 8, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • August 8, 2032
    
    ✓ 
    Patent use: ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • August 8, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • August 8, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE (STAGE III) NSCLC WHOSE DISEASE HAS NOT PROGRESSED DURING OR FOLLOWING PLATINUM-BASED CHEMORADIATION THERAPY AND WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS
    ✓ 
    Drug substance
    ✓ 
    Drug product
• 2-(2,4,5-substituted-anilino)pyrimidine compounds
  Patent 9,732,058
  Issued: August 15, 2017
  Inventor(s): Butterworth Sam & Finlay Maurice Raymond Verschoyle & Ward Richard Andrew & Redfearn Heather Marie
  Assignee(s): ASTRAZENECA AB
  

  The present invention relates to certain 2-(2,4,5-substituted-anilino)pyrimidine compounds and pharmaceutically acceptable salts thereof which may be useful in the treatment or prevention of a disease or medical condition mediated through certain mutated forms of epidermal growth factor receptor (for example the L858R activating mutant, the Exon19 deletion activating mutant and the T790M resistance mutant). Such compounds and salts thereof may be useful in the treatment or prevention of a number of different cancers. The invention also relates to pharmaceutical compositions comprising such compounds and salts thereof, especially useful polymorphic forms of these compounds and salts, intermediates useful in the manufacture of such compounds and to methods of treatment of diseases mediated by various different forms of EGFR using such compounds and salts thereof.

  Patent expiration dates:

  • July 25, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • July 25, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • July 25, 2032
    
    ✓ 
    Patent use: ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • July 25, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY
    ✓ 
    Drug substance
    ✓ 
    Drug product
  • July 25, 2032
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE (STAGE III) NSCLC WHOSE DISEASE HAS NOT PROGRESSED DURING OR FOLLOWING PLATINUM-BASED CHEMORADIATION THERAPY AND WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS
    ✓ 
    Drug substance
    ✓ 
    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:

  • April 18, 2025 - INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST
  • February 16, 2027 - IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED B
  • September 25, 2027 - TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE (STAGE III) NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS NOT PROGRESSED DURING OR FOLLOWING CONCURRENT OR SEQUENTIAL PLATINUM-BASED CHEMORADIATION THERAPY AND WHOSE TUMORS HAVE EGFR E
  • December 18, 2027 - FOR ADJUVANT THERAPY AFTER TUMOR RESECTION IN ADULT PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST

Further information

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

Medical Disclaimer