Balversa is a drug owned by Janssen Biotech Inc. It is protected by 9 US drug patents filed from 2019 to 2026 out of which none have expired yet. Balversa's patents have been open to challenges since 13 April, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2038. Details of Balversa'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. | |||
| US8895601 | Pyrazolyl quinoxaline kinase inhibitors |
Apr, 2033
(6 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). | |||
| US11077106 | Cancer treatment |
Feb, 2038
(11 years from now) | Active |
| US10478494 | FGFR/PD-1 combination therapy for the treatment of cancer |
Aug, 2036
(9 years from now) | Active |
| US12678498 | Fgfr/Pd-1 Combination Therapy For The Treatment Of Cancer |
Jun, 2036
(9 years from now) | Active |
| US10898482 | Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine |
Feb, 2036
(9 years from now) | Active |
| US11684620 | Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine |
Feb, 2036
(9 years from now) | Active |
| US12037644 | Use of FGFR mutant gene panels in identifying cancer patients that will be responsive to treatment with an FGFR inhibitor |
Oct, 2035
(9 years from now) | Active |
| US9902714 | Quinoxaline derivatives useful as FGFR kinase modulators |
Mar, 2035
(8 years from now) | Active |
| US9464071 | Pyrazolyl quinoxaline kinase inhibitors |
Apr, 2031
(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 Balversa's patents.
Latest Legal Activities on Balversa's Patents
Given below is the list of recent legal activities going on the following patents of Balversa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Aug, 2025 | US9902714 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Jan, 2025 | US11077106 |
| Patent eCofC Notification | 22 Oct, 2024 | US12037644 |
| Recordation of Patent eCertificate of Correction | 22 Oct, 2024 | US12037644 |
| Email Notification | 22 Oct, 2024 | US12037644 |
| Mail Patent eCofC Notification | 22 Oct, 2024 | US12037644 |
| Post Issue Communication - Certificate of Correction | 01 Oct, 2024 | US12037644 |
| Recordation of Patent Grant Mailed | 16 Jul, 2024 | US12037644 |
| Email Notification | 16 Jul, 2024 | US12037644 |
| Patent eGrant Notification | 16 Jul, 2024 | US12037644 |
FDA has granted several exclusivities to Balversa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Balversa, 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
Balversa.
Exclusivity Information
Balversa holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Balversa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 12, 2024 |
| New Indication(I-930) | Jan 19, 2027 |
US patents provide insights into the exclusivity only within the United States, but
Balversa 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 Balversa's family patents as well as insights into
ongoing legal events
on those patents.
Balversa's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Balversa:
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:
Balversa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 02, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Balversa Generics:
There are no approved generic versions for Balversa as of now.
How can I launch a generic of Balversa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Balversa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Balversa'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 Balversa -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 12 Apr, 2023 | 02 Feb, 2038 | Less |
About Balversa
Balversa is a drug owned by Janssen Biotech Inc. It is used for treating locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations that has progressed after prior systemic therapy. Balversa uses Erdafitinib as an active ingredient. Balversa was launched by Janssen in 2019.
Approval Date:
Balversa was approved by FDA for market use on 12 April, 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 Balversa is 12 April, 2019, its NCE-1 date is estimated to be 13 April, 2023.
Active Ingredient:
Balversa uses Erdafitinib as the active ingredient. Check out other Drugs and Companies using Erdafitinib ingredient
Treatment:
Balversa is used for treating locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations that has progressed after prior systemic therapy.
Dosage:
Balversa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |
| 4MG | TABLET | Prescription | ORAL |