Inlyta Patent Expiration

Inlyta is a drug owned by Pf Prism Cv. It is protected by 5 US drug patents filed from 2013 to 2021. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 12, 2037. Details of Inlyta'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.
US6534524 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Apr, 2025

(9 months from now)

Active
US8791140 Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals
Dec, 2030

(6 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).
US7141581 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use
Jun, 2020

(4 years ago)

Expired
US10570202 Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer
Feb, 2035

(10 years from now)

Active
US10869924 PD-L1 antagonist combination treatments
Jan, 2037

(12 years from now)

Active


FDA has granted several exclusivities to Inlyta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Inlyta, 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 Inlyta.

Exclusivity Information

Inlyta holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Inlyta's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 27, 2017

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Several oppositions have been filed on Inlyta'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 Inlyta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Inlyta patents.

Inlyta's oppositions filed in EPO

Inlyta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 27, 2018, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP08719405A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP18205542A Jun, 2022 König Szynka Tilmann von Renesse Granted and Under Opposition
EP18205542A May, 2022 Pajaro Limited Granted and Under Opposition
EP18205542A May, 2022 Pohlman, Sandra M. Granted and Under Opposition
EP18205542A May, 2022 Boult Wade Tennant LLP Granted and Under Opposition
EP18205542A May, 2022 Symbiosis IP Limited Granted and Under Opposition
EP18205542A May, 2022 Hoffmann Eitle Granted and Under Opposition
EP18205542A May, 2022 Wuesthoff & Wuesthoff Patentanwälte PartG mbB Granted and Under Opposition
EP15703439A Aug, 2019 König Szynka Tilmann von Renesse Granted and Under Opposition
EP15703439A Aug, 2019 Withers & Rogers LLP Granted and Under Opposition
EP08719405A Feb, 2018 Teva Pharmaceutical Industries Ltd Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Inlyta 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 Inlyta's family patents as well as insights into ongoing legal events on those patents.

Inlyta's family patents

Inlyta has patent protection in a total of 29 countries. It's US patent count contributes only to 20.0% of its total global patent coverage. 3 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 Inlyta.

Family Patents

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Generic Launch

Generic Release Date:

Inlyta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 12, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Inlyta Generics:

There are no approved generic versions for Inlyta as of now.

How can I launch a generic of Inlyta before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Inlyta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Inlyta'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 Inlyta -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1 mg and 5 mg 23 Feb, 2018 1 14 Dec, 2030




About Inlyta

Inlyta is a drug owned by Pf Prism Cv. It is used for the treatment of advanced renal cell carcinoma, typically in combination with other medications like avelumab or pembrolizumab. Inlyta uses Axitinib as an active ingredient. Inlyta was launched by Pf Prism Cv in 2012.

Market Authorisation Date:

Inlyta was approved by FDA for market use on 27 January, 2012.

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 Inlyta is 27 January, 2012, its NCE-1 date is estimated to be 28 January, 2016

Active Ingredient:

Inlyta uses Axitinib as the active ingredient. Check out other Drugs and Companies using Axitinib ingredient

Treatment:

Inlyta is used for the treatment of advanced renal cell carcinoma, typically in combination with other medications like avelumab or pembrolizumab.

Dosage:

Inlyta is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
5MG TABLET Prescription ORAL
1MG TABLET Prescription ORAL