Skip to Content

Generic Gilotrif Availability

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

GILOTRIF (afatinib dimaleate - tablet;oral)

  • Manufacturer: BOEHRINGER INGELHEIM
    Approval date: July 12, 2013
    Strength(s): EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE [RLD]

Has a generic version of Gilotrif been approved?

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

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

  • Substituted quinazoline derivatives
    Patent 6,251,912
    Issued: June 26, 2001
    Inventor(s): Wissner; Allan & Tsou; Hwei-Ru & Johnson; Bernard D. & Hamann; Philip R. & Zhang; Nan
    Assignee(s): American Cyanamid Company
    This invention provides compounds of formula 1 having the structure ##STR1## wherein: X, R.sub.1, R.sub.2, R.sub.3, R.sub.4, Z, X, and n are as defined hereinbefore in the specification, which are useful as antineoplastic agents and in the treatment of certain kidney diseases, such as polycystic kidney disease.
    Patent expiration dates:
    • July 29, 2018
      ✓ 
      Patent use: TREATMENT OF CANCER
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Process for preparing amino crotonyl compounds
    Patent 8,426,586
    Issued: April 23, 2013
    Assignee(s): Boehringer Ingelheim International GmbH
    An improved process for preparing 4-[(3-chloro-4-fluorophenyl)amino]-6-{[4-(N,N-dimethylamino)-1-oxo-2-buten-1-yl]amino}-7-((S)-tetrahydrofuran-3-yloxy)-quinazoline and related aminocrotonyl compounds and the preparation of a suitable salt of 4-[(3-chloro-4-fluorophenyl)amino]-6-{[4-(N,N-dimethylamino)-1-oxo-2-buten-1-yl]amino}-7-((S)-tetrahydrofuran-3-yloxy)-quinazoline for use as a pharmaceutically active substance.
    Patent expiration dates:
    • October 10, 2029
      ✓ 
      Drug substance
  • Solid pharmaceutical formulations comprising BIBW 2992
    Patent 8,545,884
    Issued: October 1, 2013
    Assignee(s): Boehringer Ingelheim International GmbH
    The present invention relates to a pharmaceutical dosage form containing the active substance BIBW 2992 as the dimaleate salt, providing an immediate release profile of the active substance, further, the invention relates to compacted intermediates comprising BIBW 2992 dimaleate salt (BIBW 2992 MA2) in form of a powder prepared using a combined roller compaction and sieving step from BIBW 2992 MA2, intermediate blends prepared from said compacted intermediate as well as solid oral formulations providing an immediate release profile of the active substance, made from said compacted intermediate or from said intermediate blends ready for use/ingestion, e.g. capsule and tablet formulations such as uncoated or film-coated tablets prepared by direct-compression, and methods for their production.
    Patent expiration dates:
    • December 19, 2029
      ✓ 
      Drug product
  • Quinazoline derivatives and pharmaceutical compositions containing them
    Patent RE43431
    Issued: May 29, 2012
    Inventor(s): Himmelsbach; Frank & Langkopf; Elke & Blech; Stefan & Jung; Birgit & Baum; Anke & Solca; Flavio
    Assignee(s): Boehringer Ingelheim Pharma GmbH & Co. KG
    A compound of general formula I wherein: Ra is a benzyl, 1-phenylethyl, or 3-chloro-4-fluorophenyl group; Rb is a dimethylamino, N-methyl-N-ethylamino, diethylamino, N-methyl-N-isopropylamino, N-methyl-N-cyclopropylamino, N-methyl-N-(2-methoxyethyl)amino, N-ethyl-N-(2-methoxyethyl)amino, bis(2-methoxyethyl)amino, morpholino, N-methyl-N-(tetrahydrofuran-3-yl)amino, N-methyl-N-(tetrahydrofuran-2-ylmethyl)amino, N-methyl-N-(tetrahydrofuran-3-ylmethyl)amino, N-methyl-N-(tetrahydropyran-4-yl)amino, or N-methyl-N-(tetrahydropyran-4-ylmethyl)amino group; and Rc is a cyclopropylmethoxy, cyclobutyloxy, cyclopentyloxy, tetrahydrofuran-3-yloxy, tetrahydrofuran-2-ylmethoxy, tetrahydrofuran-3-ylmethoxy, tetrahydropyran-4-yloxy, or tetrahydropyran-4-ylmethoxy group, or a tautomer, stereoisomer, or salt thereof, particularly the physiologically acceptable salts thereof with inorganic or organic acids or bases which have valuable pharmacological properties, in particular an inhibitory effect on signal transduction mediated by tyrosine kinases, their use in the treatment of diseases, especially tumoral diseases and diseases of the lungs and airways, and the preparation thereof.
    Patent expiration dates:
    • January 22, 2022
      ✓ 
      Drug substance

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:
    • July 12, 2018 - NEW CHEMICAL ENTITY
    • April 15, 2019 - NEW INDICATION FOR THE TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
    • July 12, 2020 - ORPHAN DRUG EXCLUSIVITY
    • April 15, 2023 - ORPHAN DRUG EXCLUSIVITY

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.
Hide