Zelboraf is a drug owned by Hoffmann La Roche Inc. It is protected by 6 US drug patents filed from 2013 to 2016 out of which none have expired yet. Zelboraf's patents have been open to challenges since 18 August, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 06, 2032. Details of Zelboraf'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. | |||
| US8741920 | Process for the manufacture of pharmaceutically active compounds |
Jul, 2030
(5 years from now) | Active |
| US7863288 | NA |
Jun, 2029
(4 years from now) | Active |
| US7504509 | Compounds and methods for development of Ret modulators |
Oct, 2026
(1 year, 11 months from now) | Active |
| US8143271 | NA |
Jun, 2026
(1 year, 7 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9447089 | Compositions and uses thereof |
Jun, 2032
(7 years from now) | Active |
| US8470818 | NA |
Aug, 2026
(1 year, 9 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 Zelboraf's patents.
Latest Legal Activities on Zelboraf's Patents
Given below is the list of recent legal activities going on the following patents of Zelboraf.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Mar, 2024 | US9447089 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Sep, 2023 | US8143271 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Jul, 2022 | US7863288 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Nov, 2021 | US8741920 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Dec, 2020 | US8470818 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Sep, 2020 | US7504509 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Mar, 2020 | US9447089 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Sep, 2019 | US8143271 |
| Post Issue Communication - Certificate of Correction | 22 Jul, 2019 | US9447089 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jul, 2018 | US7863288 |
FDA has granted several exclusivities to Zelboraf. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zelboraf, 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 Zelboraf.
Exclusivity Information
Zelboraf holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Zelboraf's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 17, 2016 |
| Orphan Drug Exclusivity(ODE) | Aug 17, 2018 |
| Orphan Drug Exclusivity(ODE-13) | Aug 17, 2018 |
| M(M-184) | Aug 31, 2019 |
| New Indication(I-757) | Nov 06, 2020 |
| Orphan Drug Exclusivity(ODE-158) | Nov 06, 2024 |
Several oppositions have been filed on Zelboraf'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 Zelboraf's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zelboraf patents.
Zelboraf's Oppositions Filed in EPO
Zelboraf has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 05, 2018, by Generics (Uk) Ltd. This opposition was filed on patent number EP15171526A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15171526A | Oct, 2018 | Generics (UK) Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Zelboraf 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 Zelboraf's family patents as well as insights into ongoing legal events on those patents.
Zelboraf's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zelboraf's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 06, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zelboraf Generics:
There are no approved generic versions for Zelboraf as of now.
About Zelboraf
Zelboraf is a drug owned by Hoffmann La Roche Inc. It is used for treating patients with unresectable or metastatic melanoma with BRAFV600E mutation. Zelboraf uses Vemurafenib as an active ingredient. Zelboraf was launched by Hoffmann La Roche in 2011.
Approval Date:
Zelboraf was approved by FDA for market use on 17 August, 2011.
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 Zelboraf is 17 August, 2011, its NCE-1 date is estimated to be 18 August, 2015.
Active Ingredient:
Zelboraf uses Vemurafenib as the active ingredient. Check out other Drugs and Companies using Vemurafenib ingredient
Treatment:
Zelboraf is used for treating patients with unresectable or metastatic melanoma with BRAFV600E mutation.
Dosage:
Zelboraf is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 240MG | TABLET | Prescription | ORAL |