Oxbryta is a drug owned by Global Blood Therapeutics Inc. It is protected by 11 US drug patents filed from 2021 to 2024 out of which none have expired yet. Oxbryta's patents have been open to challenges since 26 November, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2037. Details of Oxbryta'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. | |||
| US9447071 | Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde |
Feb, 2035
(9 years from now) | Active |
| US9018210 | Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation |
Nov, 2033
(8 years from now) | Active |
| US10034879 | Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation |
Dec, 2032
(7 years from now) | Active |
| US10806733 | Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation |
Dec, 2032
(7 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). | |||
| US10493035 | Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde |
Oct, 2037
(12 years from now) | Active |
| US11944612 | Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde |
Dec, 2036
(11 years from now) | Active |
| US11020382 | Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde |
Dec, 2036
(11 years from now) | Active |
| US11452720 | Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde |
Feb, 2035
(9 years from now) | Active |
| US10722502 | Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde |
Feb, 2035
(9 years from now) | Active |
| US9248199 | 1:1 adducts of sickle hemoglobin |
Jan, 2034
(8 years from now) | Active |
| US10017491 | Compounds and uses thereof for the modulation of hemoglobin |
Dec, 2032
(7 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 Oxbryta's patents.
Latest Legal Activities on Oxbryta's Patents
Given below is the list of recent legal activities going on the following patents of Oxbryta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 02 Apr, 2024 | US11944612 |
| Recordation of Patent eGrant | 02 Apr, 2024 | US11944612 |
| Mail Patent eGrant Notification | 02 Apr, 2024 | US11944612 |
| Recordation of Patent Grant Mailed Critical | 02 Apr, 2024 | US11944612 |
| Email Notification Critical | 02 Apr, 2024 | US11944612 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Apr, 2024 | US11944612 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Mar, 2024 | US10806733 |
| Email Notification Critical | 14 Mar, 2024 | US11944612 |
| Issue Notification Mailed Critical | 13 Mar, 2024 | US11944612 |
| Dispatch to FDC | 27 Feb, 2024 | US11944612 |
FDA has granted several exclusivities to Oxbryta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Oxbryta, 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 Oxbryta.
Exclusivity Information
Oxbryta holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Oxbryta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 25, 2024 |
| Orphan Drug Exclusivity(ODE-281) | Nov 25, 2026 |
| Orphan Drug Exclusivity(ODE-394) | Dec 17, 2028 |
Several oppositions have been filed on Oxbryta'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 Oxbryta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Oxbryta patents.
Oxbryta's Oppositions Filed in EPO
Oxbryta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 13, 2021, by Bülle Dr., Jan. This opposition was filed on patent number EP15746995A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15746995A | Oct, 2021 | Bülle Dr., Jan | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Oxbryta 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 Oxbryta's family patents as well as insights into ongoing legal events on those patents.
Oxbryta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Oxbryta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 12, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Oxbryta Generics:
There are no approved generic versions for Oxbryta as of now.
About Oxbryta
Oxbryta is a drug owned by Global Blood Therapeutics Inc. It is used for increasing hemoglobin levels and treating sickle cell disease by administering Voxelotor orally to patients. Oxbryta uses Voxelotor as an active ingredient. Oxbryta was launched by Global Blood Theraps in 2022.
Approval Date:
Oxbryta was approved by FDA for market use on 14 October, 2022.
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 Oxbryta is 14 October, 2022, its NCE-1 date is estimated to be 26 November, 2023.
Active Ingredient:
Oxbryta uses Voxelotor as the active ingredient. Check out other Drugs and Companies using Voxelotor ingredient
Treatment:
Oxbryta is used for increasing hemoglobin levels and treating sickle cell disease by administering Voxelotor orally to patients.
Dosage:
Oxbryta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG | TABLET | Discontinued | ORAL |
| 300MG | TABLET | Discontinued | ORAL |