Inlyta is a drug owned by Pf Prism Cv. It is protected by 11 US drug patents filed from 2013 to 2026. Out of these, 8 drug patents are active and 3 have expired. Inlyta's patents have been open to challenges since 28 January, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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
(4 years from now) | Active |
| US6534524 | Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use |
Apr, 2025
(1 year, 5 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10869924 (Pediatric) | PD-L1 antagonist combination treatments |
Jul, 2037
(10 years from now) | Active |
| US10869924 | PD-L1 antagonist combination treatments |
Jan, 2037
(10 years from now) | Active |
|
US10570202 (Pediatric) | Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer |
Aug, 2035
(8 years from now) | Active |
|
US12534530 (Pediatric) | Combination Of A Pd-1 Antagonist And A Vegfr Inhibitor For Treating Cancer |
Aug, 2035
(8 years from now) | Active |
| US12534530 | Combination Of A Pd-1 Antagonist And A Vegfr Inhibitor For Treating Cancer |
Feb, 2035
(8 years from now) | Active |
| US10570202 | Combination of a PD-1 antagonist and a VEGFR inhibitor for treating cancer |
Feb, 2035
(8 years from now) | Active |
|
US8791140 (Pediatric) | Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals |
Jun, 2031
(4 years from now) | Active |
|
US6534524 (Pediatric) | Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use |
Oct, 2025
(11 months ago) |
Expired
|
| US7141581 | Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use |
Jun, 2020
(6 years ago) |
Expired
|
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 Inlyta's patents.
Latest Legal Activities on Inlyta's Patents
Given below is the list of recent legal activities going on the following patents of Inlyta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Dec, 2025 | US8791140 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jun, 2024 | US10869924 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Aug, 2023 | US10570202 |
| Post Issue Communication - Certificate of Correction | 19 Apr, 2022 | US10869924 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Dec, 2021 | US8791140 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 07 Sep, 2021 | US10869924 |
| Email Notification
Critical | 04 Sep, 2021 | US10869924 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 03 Sep, 2021 | US10869924 |
| Pet Dec Routed to Certificate of Corrections Branch | 03 Sep, 2021 | US10869924 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 03 Sep, 2021 | US10869924 |
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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Inlyta:
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:
Inlyta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 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 Generic API suppliers:
Axitinib is the generic name for the brand Inlyta. 1 company has already filed for the generic of Inlyta. Check out the entire list of companies who have already received approval for Inlyta's generic
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 23 Feb, 2018 | 14 Dec, 2030 | Eligible | 30 Oct, 2025 | Less |
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.
Approval Date:
Inlyta was approved by FDA for market use on 27 January, 2012.
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 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 |
|---|---|---|---|
| 1MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |