Generic Gilotrif Availability
Last updated on Nov 6, 2024.
Gilotrif is a brand name of afatinib, approved by the FDA in the following formulation(s):
GILOTRIF (afatinib dimaleate - tablet;oral)
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Manufacturer: BOEHRINGER INGELHEIM
Approval date: July 12, 2013
Strength(s): EQ 20MG BASE [RLD], EQ 30MG BASE [RLD], 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: 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.
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Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Patent 10,004,743
Issued: June 26, 2018
Inventor(s): Barta Albert
Assignee(s): Boehringer Ingelheim International GmbHThe present invention relates to a drying process of BIBW 2992 or the salts thereof, preferably the dimaleate salt, as well as of solid pharmaceutical formulations comprising BIBW2992 or a salt thereof, and to pharmaceutical compositions comprising BIBW 2992 or a salt thereof as the active product ingredient, characterized by a water activity of the formulation of not more than 0.20 or a water content (Karl-Fischer) of not more than 4.2%.
Patent expiration dates:
- July 5, 2030✓
- July 5, 2030
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Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Patent 10004743*PE
Issued: June 26, 2018
Inventor(s): Barta Albert
Assignee(s): Boehringer Ingelheim International GmbHThe present invention relates to a drying process of BIBW 2992 or the salts thereof, preferably the dimaleate salt, as well as of solid pharmaceutical formulations comprising BIBW2992 or a salt thereof, and to pharmaceutical compositions comprising BIBW 2992 or a salt thereof as the active product ingredient, characterized by a water activity of the formulation of not more than 0.20 or a water content (Karl-Fischer) of not more than 4.2%.
Patent expiration dates:
- January 5, 2031
- January 5, 2031
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Process for preparing amino crotonyl compounds
Patent 8,426,586
Issued: April 23, 2013
Inventor(s): Soyka Rainer & Rall Werner & Schnaubelt Juergen & Sieger Peter & Kulinna Christian
Assignee(s): Boehringer Ingelheim International GmbHAn 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✓
- October 10, 2029
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Process for preparing amino crotonyl compounds
Patent 8426586*PED
Issued: April 23, 2013
Inventor(s): Soyka Rainer & Rall Werner & Schnaubelt Juergen & Sieger Peter & Kulinna Christian
Assignee(s): Boehringer Ingelheim International GmbHAn 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:
- April 10, 2030✓
- April 10, 2030
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Solid pharmaceutical formulations comprising BIBW 2992
Patent 8,545,884
Issued: October 1, 2013
Inventor(s): Messerschmid Roman & Friedl Thomas
Assignee(s): Boehringer Ingelheim International GmbHThe 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 MA) in form of a powder prepared using a combined roller compaction and sieving step from BIBW 2992 MA, 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✓
- December 19, 2029
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Solid pharmaceutical formulations comprising BIBW 2992
Patent 8545884*PED
Issued: October 1, 2013
Inventor(s): Messerschmid Roman & Friedl Thomas
Assignee(s): Boehringer Ingelheim International GmbHThe 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 MA) in form of a powder prepared using a combined roller compaction and sieving step from BIBW 2992 MA, 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:
- June 19, 2030✓
- June 19, 2030
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Quinazoline derivatives for the treatment of cancer diseases
Patent 9,539,258
Issued: January 10, 2017
Inventor(s): Solca Flavio & Amelsberg Andree & van Meel Jacobus C. A. & Baum Anke & Stehle Gerd
Assignee(s): Boehringer Ingelheim International GmbHThe present invention relates to the use of quinazolines of formula (I),
Patent expiration dates:
- November 9, 2026✓
- November 9, 2026
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Quinazoline derivatives for the treatment of cancer diseases
Patent 9539258*PED
Issued: January 10, 2017
Inventor(s): Solca Flavio & Amelsberg Andree & van Meel Jacobus C. A. & Baum Anke & Stehle Gerd
Assignee(s): Boehringer Ingelheim International GmbHThe present invention relates to the use of quinazolines of formula (I),
Patent expiration dates:
- May 9, 2027✓
- May 9, 2027
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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. KGA compound of general formula I
Patent expiration dates:
- January 13, 2026✓
- January 13, 2026
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Quinazoline derivatives and pharmaceutical compositions containing them
Patent RE43431*PED
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. KGA compound of general formula I
Patent expiration dates:
- July 13, 2026✓
- July 13, 2026
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:
- January 12, 2025 - FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
- April 7, 2025 - REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
- July 12, 2025 - PEDIATRIC EXCLUSIVITY
- October 7, 2025 - PEDIATRIC EXCLUSIVITY
More about Gilotrif (afatinib)
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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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
