Inlexzo is a drug owned by Janssen Biotech Inc. It is protected by 3 US drug patents filed in 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 19, 2034. Details of Inlexzo'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). | |||
| US10729823 | NA |
Aug, 2034
(8 years from now) | Active |
| US8679094 | NA |
Apr, 2032
(6 years from now) | Active |
| US12403086 | NA |
Jun, 2030
(4 years from now) | Active |
FDA has granted several exclusivities to Inlexzo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Inlexzo, 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 Inlexzo.
Exclusivity Information
Inlexzo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Inlexzo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 09, 2028 |
US patents provide insights into the exclusivity only within the United States, but Inlexzo 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 Inlexzo's family patents as well as insights into ongoing legal events on those patents.
Inlexzo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Inlexzo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 19, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Inlexzo Generic API suppliers:
Gemcitabine Hydrochloride is the generic name for the brand Inlexzo. 25 different companies have already filed for the generic of Inlexzo, with Shilpa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Inlexzo's generic
Alternative Brands for Inlexzo
There are several other brand drugs using the same active ingredient (Gemcitabine Hydrochloride) as Inlexzo. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Gemcitabine Hydrochloride, Inlexzo's active ingredient. Check the complete list of approved generic manufacturers for Inlexzo
About Inlexzo
Inlexzo is a drug owned by Janssen Biotech Inc. Inlexzo uses Gemcitabine Hydrochloride as an active ingredient. Inlexzo was launched by Janssen Biotech in 2025.
Approval Date:
Inlexzo was approved by FDA for market use on 09 September, 2025.
Active Ingredient:
Inlexzo uses Gemcitabine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Gemcitabine Hydrochloride ingredient
Dosage:
Inlexzo is available in system form for intravesical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 225MG BASE | SYSTEM | Prescription | INTRAVESICAL |