Balversa Patent Expiration

Balversa is a drug owned by Janssen Biotech Inc. It is protected by 6 US drug patents filed from 2019 to 2023 out of which none have expired yet. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8895601 Pyrazolyl quinoxaline kinase inhibitors
Apr, 2033

(8 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9464071 Pyrazolyl quinoxaline kinase inhibitors
Apr, 2031

(6 years from now)

Active
US9902714 Quinoxaline derivatives useful as FGFR kinase modulators
Mar, 2035

(10 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

(11 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

(11 years from now)

Active
US11077106 Cancer treatment
Feb, 2038

(13 years from now)

Active


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

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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

Balversa has patent protection in a total of 42 countries. It's US patent count contributes only to 9.8% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Balversa.

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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 ANDA(s) Filed First applicant approval Last patent expiry 180 day status
3 mg, 4 mg and 5 mg 12 Apr, 2023 1 02 Feb, 2038




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 Biotech in 2019.

Market Authorisation Date:

Balversa was approved by FDA for market use on 12 April, 2019.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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
4MG TABLET Prescription ORAL
5MG TABLET Prescription ORAL