Generic Tarceva Availability

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

TARCEVA (erlotinib hydrochloride - tablet;oral)

  • Manufacturer: OSI PHARMS
    Approval date: November 18, 2004
    Strength(s): EQ 25MG BASE, EQ 100MG BASE, EQ 150MG BASE [RLD]

Has a generic version of Tarceva been approved?

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

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

  • Alkynyl and azido-substituted 4-anilinoquinazolines
    Patent 5,747,498
    Issued: May 5, 1998
    Inventor(s): Schnur; Rodney Caughren & Arnold; Lee Daniel
    Assignee(s): Pfizer Inc.
    The invention relates to compounds of the formula ##STR1## and to pharmaceutically acceptable salts thereof, wherein R.sup.1, R.sup.2, R.sup.3, R.sup.4, n and m are as defined herein. The compounds of formula I are useful in the treatment of hyperproliferative diseases, such as cancer. The invention further relates to processes of making the compounds of formula I and to methods of using such compounds in the treatment of hyperproliferative diseases.
    Patent expiration dates:
    • November 8, 2018
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      Patent use: TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
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  • Stable polymorph on N-(3-ethynylphenyl)-6, 7-bis (2methoxyethoxy)-4-quinazolinamine hydrochloride, methods of production, and pharmaceutical uses thereof
    Patent 6,900,221
    Issued: May 31, 2005
    Inventor(s): Norris; Timothy & Raggon; Jeffrey W. & Connell; Richard D. & Moyer; James D. & Morin; Michael J. & Kajiji; Shama M. & Foster; Barbara A. & Ferrante; Karen J. & Silberman; Sandra L.
    Assignee(s): OSI Pharmaceuticals, Inc.
    The present invention relates to a stable crystalline form of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride designated the B polymorph, its production in essentially pure form, and its use. The invention also relates to the pharmaceutical compositions containing the stable polymorph B form of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine as hydrochloride, as well other forms of the compound, and to methods of treating hyperproliferative disorders, such as cancer, by administering the compound.
    Patent expiration dates:
    • November 9, 2020
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      Patent use: FIRST-LINE TREATMENT OF METASTATIC NON SMAL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
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    • November 9, 2020
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      Patent use: MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES PLATINUM-BASED CHEMOTHERAPY
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    • November 9, 2020
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      Patent use: FIRST-LINE TREATMENT OF LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER, IN COMBINATION WITH GEMCITABINE
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    • November 9, 2020
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      Patent use: TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
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  • Treating abnormal cell growth with a stable polymorph of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride
    Patent 7,087,613
    Issued: August 8, 2006
    Inventor(s): Norris; Timothy & Raggon; Jeffrey W. & Connell; Richard D. & Moyer; James D. & Morin; Michael J. & Kajiji; Shama M. & Foster; Barbara A. & Ferrante; Karen J. & Silberman; Sandra L.
    Assignee(s): OSI Pharmaceuticals, Inc.
    A method of monotherapy for a subject suffering from abnormal cell growth expressing the epidermal growth factor receptor (EGFR) which comprises orally administering to the subject a therapeutically effective amount of a crystalline polymorph of the hydrochloride salt of N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine so as to treat the subject.
    Patent expiration dates:
    • November 9, 2020
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      Patent use: FIRST-LINE TREATMENT OF METASTATIC NON SMAL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
    • November 9, 2020
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      Patent use: MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHO HAVE NOT PROGRESSED ON 1ST-LINE TREATMENT WTH PLATINUM-BASED CHEMOTHERAPY
    • November 9, 2020
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      Patent use: TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
  • Alkynl and azido-substituted 4-anilinoquinazolines
    Patent RE41065
    Issued: December 29, 2009
    Inventor(s): Schnur; Rodney Caughren & Arnold; Lee Daniel
    Assignee(s): Pfizer, Inc. OSI Pharmaceuticals, Inc.
    The invention relates to compounds of the formula and to pharmaceutically acceptable salts thereof, wherein R1, R2, R3, R4, n and m are as defined herein. The compounds of formula I are useful in the treatment of hyperproliferative diseases, such as cancer. The invention further relates to processes of making the compounds of formula I and to methods of using such compounds in the treatment of hyperproliferative diseases.
    Patent expiration dates:
    • November 8, 2018
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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 14, 2016 - FIRSTLINE 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) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA- APPROVED TEST

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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