Nubeqa is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2019 to 2026 out of which none have expired yet. Nubeqa's patents have been open to challenges since 31 July, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 17, 2042. Details of Nubeqa'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. | |||
| US11168058 | Manufacture of a crystalline pharmaceutical product |
Feb, 2038
(11 years from now) | Active |
| US10383853 | Carboxamide derivative and its diastereomers in stable crystalline form |
Jan, 2036
(9 years from now) | Active |
| US10010530 | Carboxamide derivative and its diastereomers in stable crystalline form |
Jan, 2036
(9 years from now) | Active |
| US8975254 | Androgen receptor modulating compounds |
Mar, 2033
(6 years from now) | Active |
| US10711013 | Androgen receptor modulating compounds |
Oct, 2030
(4 years from now) | Active |
| US11046713 | Androgen receptor modulating compounds |
Oct, 2030
(4 years from now) | Active |
| US9657003 | Androgen receptor modulating compounds |
Oct, 2030
(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). | |||
| US12329742 | Pharmaceutical composition of darolutamide |
Jun, 2042
(15 years from now) | Active |
| US12611397 | NA |
Jul, 2040
(13 years from now) | Active |
| US10835515 | Carboxamide derivative and its diastereomers in stable crystalline form |
Jan, 2036
(9 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 Nubeqa's patents.
Latest Legal Activities on Nubeqa's Patents
Given below is the list of recent legal activities going on the following patents of Nubeqa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Dec, 2025 | US10010530 |
| Recordation of Patent eCertificate of Correction | 16 Dec, 2025 | US12329742 |
| Patent eCofC Notification | 16 Dec, 2025 | US12329742 |
| Mail Patent eCofC Notification | 16 Dec, 2025 | US12329742 |
| Email Notification | 16 Dec, 2025 | US12329742 |
| Post Issue Communication - Certificate of Correction | 25 Nov, 2025 | US12329742 |
| Email Notification | 23 Oct, 2025 | US12329742 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 22 Oct, 2025 | US12329742 |
| Mail-Petition Decision - Dismissed | 22 Oct, 2025 | US12329742 |
| Pet Dec Routed to Certificate of Corrections Branch | 21 Oct, 2025 | US12329742 |
FDA has granted several exclusivities to Nubeqa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Nubeqa, 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
Nubeqa.
Exclusivity Information
Nubeqa holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Nubeqa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 30, 2024 |
| New Indication(I-900) | Aug 05, 2025 |
| New Indication(I-971) | Jun 03, 2028 |
Several oppositions have been filed on Nubeqa'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 Nubeqa's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Nubeqa patents.
Nubeqa's Oppositions Filed in EPO
Nubeqa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 17, 2023, by Hamm&Wittkopp Patentanwälte Partmbb. This opposition was filed on patent number EP16704029A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16704029A | Feb, 2023 | Hamm&Wittkopp Patentanwälte PartmbB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but
Nubeqa 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 Nubeqa's family patents as well as insights into
ongoing legal events
on those patents.
Nubeqa's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Nubeqa:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Nubeqa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 17, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nubeqa Generics:
There are no approved generic versions for Nubeqa as of now.
How can I launch a generic of Nubeqa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nubeqa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nubeqa'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 Nubeqa -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 31 Jul, 2023 | 27 Feb, 2038 | Less |
About Nubeqa
Nubeqa is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating non-metastatic castration-resistant prostate cancer. Nubeqa uses Darolutamide as an active ingredient. Nubeqa was launched by Bayer in 2019.
Approval Date:
Nubeqa was approved by FDA for market use on 30 July, 2019.
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 Nubeqa is 30 July, 2019, its NCE-1 date is estimated to be 31 July, 2023.
Active Ingredient:
Nubeqa uses Darolutamide as the active ingredient. Check out other Drugs and Companies using Darolutamide ingredient
Treatment:
Nubeqa is used for treating non-metastatic castration-resistant prostate cancer.
Dosage:
Nubeqa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG | TABLET | Prescription | ORAL |