Braftovi is a drug owned by Array Biopharma Inc. It is protected by 14 US drug patents filed from 2018 to 2023 out of which none have expired yet. Braftovi's patents have been open to challenges since 27 June, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 05, 2033. Details of Braftovi'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. | |||
| US8501758 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(5 years from now) | Active |
| US9593099 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(5 years from now) | Active |
| USRE49556 | Compounds and compositions as protein kinase inhibitors |
Feb, 2030
(5 years from now) | Active |
| US8541575 | 3,4-diarylpyrazoles as protein kinase inhibitors |
Feb, 2030
(5 years from now) | Active |
| US8946250 | 3,4-diarylpyrazoles as protein kinase inhibitors |
Jul, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9474754 | Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-α inhibitor |
Aug, 2033
(8 years from now) | Active |
| US9763941 | Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate |
Nov, 2032
(7 years from now) | Active |
| US9387208 | Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate |
Nov, 2032
(7 years from now) | Active |
| US10258622 | Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate |
Nov, 2032
(7 years from now) | Active |
| US9314464 | Compounds and compositions as protein kinase inhibitors |
Jul, 2031
(6 years from now) | Active |
| US10005761 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(5 years from now) | Active |
| US9850229 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(5 years from now) | Active |
| US9593100 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(5 years from now) | Active |
| US9850230 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(5 years 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 Braftovi's patents.
Latest Legal Activities on Braftovi's Patents
Given below is the list of recent legal activities going on the following patents of Braftovi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Resp. to req. for info. sent under 37 CFR 1.750 | 21 Jun, 2024 | US9593099 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 21 Jun, 2024 | US9314464 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 21 Jun, 2024 | US9593100 |
| Withdrawal of Application for PTE Critical | 21 Jun, 2024 | US9314464 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Mar, 2024 | US9474754 |
| Mail-Petition Decision - Granted | 23 Jan, 2024 | US8501758 |
| Requirement for information sent under 37 CFR 1.750 | 22 Jan, 2024 | US9314464 |
| Requirement for information sent under 37 CFR 1.750 | 22 Jan, 2024 | US8501758 |
| Petition Decision - Granted Critical | 22 Jan, 2024 | US8501758 |
| Requirement for information sent under 37 CFR 1.750 | 22 Jan, 2024 | US9593099 |
FDA has granted several exclusivities to Braftovi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Braftovi, 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 Braftovi.
Exclusivity Information
Braftovi holds 5 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Braftovi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-826) | Apr 08, 2023 |
| New Chemical Entity Exclusivity(NCE) | Jun 27, 2023 |
| Orphan Drug Exclusivity(ODE-194) | Jun 27, 2025 |
| New Indication(I-928) | Oct 11, 2026 |
| Orphan Drug Exclusivity(ODE-445) | Oct 11, 2030 |
US patents provide insights into the exclusivity only within the United States, but Braftovi 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 Braftovi's family patents as well as insights into ongoing legal events on those patents.
Braftovi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Braftovi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 05, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Braftovi Generics:
There are no approved generic versions for Braftovi as of now.
How can I launch a generic of Braftovi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Braftovi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Braftovi'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 Braftovi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg | 27 Jun, 2022 | 3 | 05 Aug, 2033 |
Alternative Brands for Braftovi
Braftovi which is used for treating metastatic non-small cell lung cancer, metastatic colorectal cancer, and melanoma with BRAF mutations., 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 | ||
|---|---|---|---|---|
| Array Biopharma Inc |
| |||
About Braftovi
Braftovi is a drug owned by Array Biopharma Inc. It is used for treating metastatic non-small cell lung cancer, metastatic colorectal cancer, and melanoma with BRAF mutations. Braftovi uses Encorafenib as an active ingredient. Braftovi was launched by Array Biopharma Inc in 2018.
Approval Date:
Braftovi was approved by FDA for market use on 27 June, 2018.
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 Braftovi is 27 June, 2018, its NCE-1 date is estimated to be 27 June, 2022.
Active Ingredient:
Braftovi uses Encorafenib as the active ingredient. Check out other Drugs and Companies using Encorafenib ingredient
Treatment:
Braftovi is used for treating metastatic non-small cell lung cancer, metastatic colorectal cancer, and melanoma with BRAF mutations.
Dosage:
Braftovi is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 75MG | CAPSULE | Prescription | ORAL |
| 50MG | CAPSULE | Discontinued | ORAL |