Gilotrif is a drug owned by Boehringer Ingelheim. It is protected by 11 US drug patents filed from 2013 to 2022. Out of these, 10 drug patents are active and 1 has expired. Gilotrif's patents have been open to challenges since 07 October, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 05, 2031. Details of Gilotrif's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8426586 | Process for preparing amino crotonyl compounds |
Oct, 2029
(4 years from now) | Active |
| USRE43431 | Quinazoline derivatives and pharmaceutical compositions containing them |
Jan, 2026
(1 year, 1 month from now) | Active |
| US6251912 | Substituted quinazoline derivatives |
Jul, 2018
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10004743 (Pediatric) | Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient |
Jan, 2031
(6 years from now) | Active |
| US10004743 | Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient |
Jul, 2030
(5 years from now) | Active |
|
US8545884 (Pediatric) | Solid pharmaceutical formulations comprising BIBW 2992 |
Jun, 2030
(5 years from now) | Active |
|
US8426586 (Pediatric) | Process for preparing amino crotonyl compounds |
Apr, 2030
(5 years from now) | Active |
| US8545884 | Solid pharmaceutical formulations comprising BIBW 2992 |
Dec, 2029
(5 years from now) | Active |
|
US9539258 (Pediatric) | Quinazoline derivatives for the treatment of cancer diseases |
May, 2027
(2 years from now) | Active |
| US9539258 | Quinazoline derivatives for the treatment of cancer diseases |
Nov, 2026
(1 year, 11 months from now) | Active |
|
USRE43431 (Pediatric) | Quinazoline derivatives and pharmaceutical compositions containing them |
Jul, 2026
(1 year, 7 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Gilotrif's patents.
Latest Legal Activities on Gilotrif's Patents
Given below is the list of recent legal activities going on the following patents of Gilotrif.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jul, 2024 | US9539258 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Dec, 2021 | US10004743 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Oct, 2020 | US8545884 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Sep, 2020 | US8426586 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Jun, 2020 | US9539258 |
| Recordation of Patent Grant Mailed Critical | 26 Jun, 2018 | US10004743 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Jun, 2018 | US10004743 |
| Email Notification Critical | 07 Jun, 2018 | US10004743 |
| Issue Notification Mailed Critical | 06 Jun, 2018 | US10004743 |
| Dispatch to FDC | 24 May, 2018 | US10004743 |
FDA has granted several exclusivities to Gilotrif. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gilotrif, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gilotrif.
Exclusivity Information
Gilotrif holds 9 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Gilotrif's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 12, 2018 |
| New Indication(I-730) | Apr 15, 2019 |
| Orphan Drug Exclusivity(ODE-50) | Jul 12, 2020 |
| New Indication(I-763) | Jan 12, 2021 |
| Orphan Drug Exclusivity(ODE) | Apr 15, 2023 |
| Orphan Drug Exclusivity(ODE-115) | Apr 15, 2023 |
| Orphan Drug Exclusivity(ODE-230) | Jan 12, 2025 |
| M(M-276) | Apr 07, 2025 |
| Pediatric Exclusivity(PED) | Oct 07, 2025 |
Several oppositions have been filed on Gilotrif's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Gilotrif's generic, the next section provides detailed information on ongoing and past EP oppositions related to Gilotrif patents.
Gilotrif's Oppositions Filed in EPO
Gilotrif has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 30, 2016, by Lek Pharmaceuticals D.D.. This opposition was filed on patent number EP12155662A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10730454A | Dec, 2019 | Generics [UK] Ltd | Granted and Under Opposition |
| EP10730454A | Dec, 2019 | LEK Pharmaceuticals d.d. | Granted and Under Opposition |
| EP10730454A | Nov, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP12155662A | Sep, 2016 | LEK Pharmaceuticals d.d. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Gilotrif is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gilotrif's family patents as well as insights into ongoing legal events on those patents.
Gilotrif's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gilotrif's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 05, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gilotrif Generics:
There are no approved generic versions for Gilotrif as of now.
How can I launch a generic of Gilotrif before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gilotrif's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gilotrif's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Gilotrif -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 30 mg and 40 mg | 12 Jul, 2017 | 7 | 19 Dec, 2029 |
Alternative Brands for Gilotrif
Gilotrif which is used for treating cancer, specifically advanced non-small cell lung cancer that has progressed after platinum-based chemotherapy., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Sanofi Aventis Us |
| |||
About Gilotrif
Gilotrif is a drug owned by Boehringer Ingelheim. It is used for treating cancer, specifically advanced non-small cell lung cancer that has progressed after platinum-based chemotherapy. Gilotrif uses Afatinib Dimaleate as an active ingredient. Gilotrif was launched by Boehringer Ingelheim in 2013.
Approval Date:
Gilotrif was approved by FDA for market use on 12 July, 2013.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Gilotrif is 12 July, 2013, its NCE-1 date is estimated to be 07 October, 2024.
Active Ingredient:
Gilotrif uses Afatinib Dimaleate as the active ingredient. Check out other Drugs and Companies using Afatinib Dimaleate ingredient
Treatment:
Gilotrif is used for treating cancer, specifically advanced non-small cell lung cancer that has progressed after platinum-based chemotherapy.
Dosage:
Gilotrif is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 30MG BASE | TABLET | Prescription | ORAL |
| EQ 40MG BASE | TABLET | Prescription | ORAL |