Onureg is a drug owned by Bristol Myers Squibb Co. It is protected by 3 US drug patents filed from 2020 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 03, 2030. Details of Onureg's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8846628 | Oral formulations of cytidine analogs and methods of use thereof |
Jun, 2030
(5 years from now) | Active |
| US12053482 | Oral formulations of cytidine analogs and methods of use thereof |
May, 2029
(4 years from now) | Active |
| US11571436 | Oral formulations of cytidine analogs and methods of use thereof |
May, 2029
(4 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 Onureg's patents.
Latest Legal Activities on Onureg's Patents
Given below is the list of recent legal activities going on the following patents of Onureg.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Termination or Final Written Decision | 05 Jan, 2024 | US8846628 |
| Request for Trial Granted Critical | 20 Jul, 2023 | US8846628 |
| Petition Requesting Trial | 15 Feb, 2023 | US8846628 |
| Recordation of Patent Grant Mailed Critical | 07 Feb, 2023 | US11571436 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Feb, 2023 | US11571436 |
| Email Notification Critical | 19 Jan, 2023 | US11571436 |
| Issue Notification Mailed Critical | 18 Jan, 2023 | US11571436 |
| Application Is Considered Ready for Issue Critical | 12 Jan, 2023 | US11571436 |
| Dispatch to FDC | 12 Jan, 2023 | US11571436 |
| Workflow - Drawings Finished | 05 Oct, 2022 | US11571436 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Onureg and ongoing litigations to help you estimate the early arrival of Onureg generic.
Onureg's Litigations
Onureg been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 10, 2023, against patent number US8846628. The petitioner Apotex Inc. et al., challenged the validity of this patent, with CELGENE CORPORATION et al. as the respondent. Click below to track the latest information on how companies are challenging Onureg's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8846628 | February, 2023 |
Terminated-Settled
(05 Jan, 2024) | CELGENE CORPORATION et al. | Apotex Inc. et al. |
FDA has granted some exclusivities to Onureg. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Onureg, 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 Onureg.
Exclusivity Information
Onureg holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Onureg's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 01, 2023 |
| Orphan Drug Exclusivity(ODE-320) | Sep 01, 2027 |
Several oppositions have been filed on Onureg'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 Onureg's generic, the next section provides detailed information on ongoing and past EP oppositions related to Onureg patents.
Onureg's Oppositions Filed in EPO
Onureg has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 27, 2019, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP09746975A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP20201105A | Apr, 2023 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP20201105A | Apr, 2023 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP20201105A | Mar, 2023 | Synthon BV | Granted and Under Opposition |
| EP20201105A | Mar, 2023 | Hamm&Wittkopp Patentanwälte PartmbB | Granted and Under Opposition |
| EP20201105A | Mar, 2023 | SANDOZ AG | Granted and Under Opposition |
| EP19213148A | May, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP19213148A | May, 2022 | Generics [UK] Limited | Granted and Under Opposition |
| EP19213148A | May, 2022 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Granted and Under Opposition |
| EP19213148A | May, 2022 | Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB | Granted and Under Opposition |
| EP19213148A | May, 2022 | SANDOZ AG | Granted and Under Opposition |
| EP19213148A | Apr, 2022 | Lotus Pharmaceutical Co., Ltd. | Granted and Under Opposition |
| EP13182721A | Sep, 2020 | SANDOZ AG | Granted and Under Opposition |
| EP13182721A | Sep, 2020 | Hoffmann Eitle | Granted and Under Opposition |
| EP13182721A | Sep, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP13182721A | Aug, 2020 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP09746975A | Aug, 2019 | Generics (UK) Ltd | Granted and Under Opposition |
| EP09746975A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Onureg 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 Onureg's family patents as well as insights into ongoing legal events on those patents.
Onureg's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Onureg's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 03, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Onureg Generic API suppliers:
Azacitidine is the generic name for the brand Onureg. 14 different companies have already filed for the generic of Onureg, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Onureg's generic
How can I launch a generic of Onureg before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Onureg's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Onureg'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 Onureg -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg and 300 mg | 30 Sep, 2021 | 1 | 03 Jun, 2030 |
About Onureg
Onureg is a drug owned by Bristol Myers Squibb Co. It is used for continued treatment of adults with acute myeloid leukemia who achieved first complete remission following intensive chemotherapy. Onureg uses Azacitidine as an active ingredient. Onureg was launched by Bristol in 2020.
Approval Date:
Onureg was approved by FDA for market use on 01 September, 2020.
Active Ingredient:
Onureg uses Azacitidine as the active ingredient. Check out other Drugs and Companies using Azacitidine ingredient
Treatment:
Onureg is used for continued treatment of adults with acute myeloid leukemia who achieved first complete remission following intensive chemotherapy.
Dosage:
Onureg is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Prescription | ORAL |
| 300MG | TABLET | Prescription | ORAL |