Afinitor is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 14 US drug patents filed from 2013 to 2015. Out of these, 1 drug patents are active and 13 have expired. Afinitor's patents have been open to challenges since 26 October, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2028. Details of Afinitor'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). | |||
| US9006224 | Neuroendocrine tumor treatment |
Jul, 2028
(1 year, 8 months from now) | Active |
|
US8410131 (Pediatric) | Cancer treatment |
May, 2026
(5 months ago) |
Expired
|
| US8410131 | Cancer treatment |
Nov, 2025
(11 months ago) |
Expired
|
|
US8436010 (Pediatric) | Treatment of solid tumors with rapamycin derivatives |
Aug, 2022
(4 years ago) |
Expired
|
|
US8778962 (Pediatric) | Treatment of solid tumors with rapamycin derivatives |
Aug, 2022
(4 years ago) |
Expired
|
| US8436010 | Treatment of solid tumors with rapamycin derivatives |
Feb, 2022
(4 years ago) |
Expired
|
| US8778962 | Treatment of solid tumors with rapamycin derivatives |
Feb, 2022
(4 years ago) |
Expired
|
|
US7297703 (Pediatric) | Macrolides |
Jun, 2020
(6 years ago) |
Expired
|
|
US5665772 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar, 2020
(6 years ago) |
Expired
|
| US7297703 | Macrolides |
Dec, 2019
(6 years ago) |
Expired
|
| US7741338 | Macrolides |
Dec, 2019
(6 years ago) |
Expired
|
| US5665772 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep, 2019
(7 years ago) |
Expired
|
|
US6004973 (Pediatric) | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jan, 2017
(9 years ago) |
Expired
|
| US6004973 | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jul, 2016
(10 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 Afinitor's patents.
Latest Legal Activities on Afinitor's Patents
Given below is the list of recent legal activities going on the following patents of Afinitor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed | 02 Mar, 2026 | US8778962 |
| Expire Patent | 09 Jun, 2025 | US8436010 (Litigated) |
| Maintenance Fee Reminder Mailed | 23 Dec, 2024 | US8436010 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Sep, 2024 | US8410131 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2022 | US9006224 |
| Expire Patent
Critical | 25 Jul, 2022 | US7741338 |
| Maintenance Fee Reminder Mailed
Critical | 07 Feb, 2022 | US7741338 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Dec, 2021 | US8778962 |
| Review Certificate Mailed | 23 Aug, 2021 | US9006224 |
| Review Certificate | 05 Aug, 2021 | US9006224 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Afinitor and ongoing
litigations to
help you estimate the early arrival of Afinitor generic.
Afinitor's Litigations
Afinitor been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 26, 2015, against patent number US7741338. The petitioner Par Pharmaceutical, Inc. et al., challenged the validity of this patent, with Novartis AG as the respondent. Click below to track the latest information on how companies are challenging Afinitor's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9006224 | July, 2016 |
Final Written Decision
(05 Oct, 2020) | Novartis AG | Par Pharmaceutical, Inc. et al. |
| US8410131 | June, 2017 |
Terminated-Settled
(03 Jun, 2019) | Novartis Pharmaceuticals Corporation | Breckenridge Pharmaceutial, Inc. |
| US8410131 | January, 2018 |
Terminated-Settled
(03 Jun, 2019) | Novartis Pharmaceuticals Corporation | Hikma Pharmaceuticals PLC |
| US5665772 | October, 2015 |
Final Written Decision
(11 Jan, 2018) | Novartis AG | Par Pharmaceutical, Inc. et al. |
| US9006224 | March, 2017 |
Final Written Decision
(25 Sep, 2017) | Novartis AG | Argentum Pharmaceuticals LLC et al. |
| US9006224 | March, 2017 |
Terminated-Settled
(25 Sep, 2017) | Novartis AG | West-Ward Pharmaceuticals International Limited |
| US9006224 | July, 2016 |
Institution Denied
(13 Feb, 2017) | Novartis AG | Roxane Laboratories, Inc. et al. |
| US5665772 | May, 2016 |
Final Written Decision
(27 Oct, 2016) | Novartis AG | BRECKENRIDGE PHARMACEUTICAL, INC. |
| US5665772 | May, 2016 |
Institution Denied
(27 Oct, 2016) | Novartis AG | Par Pharmaceutical, Inc. et al. |
| US5665772 | May, 2016 |
Final Written Decision
(27 Oct, 2016) | Novartis AG | Roxane Laboratories, Inc. et al. |
| US5665772 | May, 2016 |
Institution Denied
(27 Oct, 2016) | Novartis AG | Breckenridge Pharmaceutical, Inc. |
| US7297703 | October, 2015 |
Institution Denied
(01 Apr, 2016) | Novartis AG | Par Pharmaceutical, Inc. et al. |
| US7741338 | October, 2015 |
Institution Denied
(01 Apr, 2016) | Novartis AG | Par Pharmaceutical, Inc. et al. |
FDA has granted some exclusivities to Afinitor. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Afinitor,
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
Afinitor.
Exclusivity Information
Afinitor holds 11 exclusivities. All of its exclusivities have expired in 2023. Details of Afinitor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-630) | Oct 29, 2013 |
| New Chemical Entity Exclusivity(NCE) | Mar 30, 2014 |
| New Indication(I-638) | May 05, 2014 |
| New Indication(I-650) | Apr 26, 2015 |
| New Indication(I-655) | Jul 20, 2015 |
| Pediatric Exclusivity(PED) | Apr 29, 2018 |
| Orphan Drug Exclusivity(ODE) | Apr 26, 2019 |
| Orphan Drug Exclusivity(ODE-11) | May 05, 2018 |
| New Indication(I-724) | Feb 26, 2019 |
| Orphan Drug Exclusivity(ODE-24) | Apr 26, 2019 |
| Orphan Drug Exclusivity(ODE-108) | Feb 26, 2023 |
Several oppositions have been filed on Afinitor'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 Afinitor's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Afinitor patents.
Afinitor's Oppositions Filed in EPO
Afinitor has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 16, 2015, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP10175197A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP18155722A | Jan, 2023 | Generics [UK] Limited | Granted and Under Opposition |
| EP18155722A | Jan, 2023 | Ethypharm | Granted and Under Opposition |
| EP18155722A | Jan, 2023 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP18155724A | Jun, 2020 | ARROW GENERIQUES | Granted and Under Opposition |
| EP18155724A | May, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP18155724A | May, 2020 | Zentiva k.s. | Granted and Under Opposition |
| EP18155724A | May, 2020 | Generics [UK] Ltd | Granted and Under Opposition |
| EP18155724A | Apr, 2020 | PUREN Pharma GmbH & Co. KG | Granted and Under Opposition |
| EP18155644A | Feb, 2020 | ARROW GENERIQUES | Granted and Under Opposition |
| EP18155644A | Feb, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP18155644A | Feb, 2020 | Generics [UK] Limited | Granted and Under Opposition |
| EP18155724A | Feb, 2020 | Ethypharm | Granted and Under Opposition |
| EP18155644A | Jan, 2020 | Dr. Reddy's Laboratories Limited | Granted and Under Opposition |
| EP18155724A | Sep, 2019 | BIOGARAN | Granted and Under Opposition |
| EP18155644A | Sep, 2019 | Zentiva Pharma GmbH | Granted and Under Opposition |
| EP16186041A | Sep, 2019 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP16186041A | Sep, 2019 | Generics [UK] Ltd | Granted and Under Opposition |
| EP16186041A | Sep, 2019 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP16186041A | Sep, 2019 | Zentiva k.s. | Granted and Under Opposition |
| EP16186041A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP18155724A | Aug, 2019 | Dr. Reddy's Laboratories / Betapharm Arzneimittel GmbH | Granted and Under Opposition |
| EP16186041A | Aug, 2019 | Synthon B.V. | Granted and Under Opposition |
| EP18155724A | Aug, 2019 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP18155724A | Aug, 2019 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP18155644A | Jul, 2019 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP10174983A | Jul, 2019 | Zentiva France | Revoked |
| EP18155644A | Jul, 2019 | Ethypharm | Granted and Under Opposition |
| EP18155644A | Jul, 2019 | BIOGARAN | Granted and Under Opposition |
| EP16186041A | Jun, 2019 | Ethypharm | Granted and Under Opposition |
| EP18155644A | May, 2019 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP14164259A | Mar, 2018 | Generics (UK) Ltd | Revoked |
| EP14164565A | Dec, 2017 | Generics (U.K.) Limited | Revoked |
| EP14164565A | Dec, 2017 | Ethypharm | Revoked |
| EP10174985A | Apr, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP10174985A | Apr, 2017 | Wittkopp, Alexander | Revoked |
| EP10174985A | Apr, 2017 | STADA Arzneimittel AG | Revoked |
| EP10174985A | Apr, 2017 | Generics [UK] Ltd | Revoked |
| EP10174985A | Apr, 2017 | Intas Pharmaceuticals Ltd. | Revoked |
| EP10174985A | Apr, 2017 | KRKA, d.d., Novo mesto | Revoked |
| EP10174985A | Apr, 2017 | Fresenius Kabi Deutschland GmbH | Revoked |
| EP10174985A | Apr, 2017 | Synthon Biopharmaceuticals B.V. | Revoked |
| EP10174983A | Feb, 2016 | Intas Pharmaceuticals Ltd. | Revoked |
| EP10174983A | Feb, 2016 | STADA Arzneimittel AG | Revoked |
| EP10174983A | Feb, 2016 | Synthon B.V. | Revoked |
| EP10174983A | Feb, 2016 | Wittkopp, Alexander | Revoked |
| EP10174983A | Feb, 2016 | Actavis PTC ehf | Revoked |
| EP10174983A | Feb, 2016 | Generics [UK] Limited | Revoked |
| EP10174983A | Feb, 2016 | Ethypharm | Revoked |
| EP10174983A | Feb, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP10175197A | Jan, 2015 | Maiwald Patentanwalts GmbH | Revoked |
| EP10175197A | Jan, 2015 | Ethypharm | Revoked |
| EP10175197A | Jan, 2015 | Synthon B.V./Genthon B.V. | Revoked |
| EP10175197A | Jan, 2015 | Generics [UK] Limited (trading as Mylan) | Revoked |
| EP10175197A | Jan, 2015 | Teva Pharmaceutical Industries Ltd. | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Afinitor 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 Afinitor's family patents as well as insights into
ongoing legal events
on those patents.
Afinitor's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Afinitor:
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:
Afinitor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Afinitor Generic API suppliers:
Everolimus is the generic name for the brand Afinitor. 14 different companies have already filed for the generic of Afinitor, with Biocon Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Afinitor's generic
How can I launch a generic of Afinitor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Afinitor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Afinitor'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 Afinitor -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 10 Dec, 2014 | 06 Dec, 2019 | Extinguished | 09 Dec, 2019 | Less | |
| 18 Jun, 2014 | 06 Dec, 2019 | Extinguished | Less |
Alternative Brands for Afinitor
Afinitor which is used for treating advanced hormone receptor positive, HER2-negative breast cancer, progressive neuroendocrine tumors of pancreatic origin, tuberous sclerosis complex with subependymal giant cell astrocytoma, and solid excretory system tumors including advanced renal cell carcinoma., has several other brand drugs using the same active ingredient (Everolimus). 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.
| Drug Owner | Drug Name | |
|---|---|---|
| Novartis |
| |
| Novartis Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Everolimus, Afinitor's active ingredient. Check the complete list of approved generic manufacturers for Afinitor
About Afinitor
Afinitor is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating advanced hormone receptor positive, HER2-negative breast cancer, progressive neuroendocrine tumors of pancreatic origin, tuberous sclerosis complex with subependymal giant cell astrocytoma, and solid excretory system tumors including advanced renal cell carcinoma. Afinitor uses Everolimus as an active ingredient. Afinitor was launched by Novartis in 2010.
Can you believe Afinitor received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Afinitor was approved by FDA for market use on 09 July, 2010.
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 Afinitor is 09 July, 2010, its NCE-1 date is estimated to be 26 October, 2014.
Active Ingredient:
Afinitor uses Everolimus as the active ingredient. Check out other Drugs and Companies using Everolimus ingredient
Treatment:
Afinitor is used for treating advanced hormone receptor positive, HER2-negative breast cancer, progressive neuroendocrine tumors of pancreatic origin, tuberous sclerosis complex with subependymal giant cell astrocytoma, and solid excretory system tumors including advanced renal cell carcinoma.
Dosage:
Afinitor is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 2.5MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |
| 7.5MG | TABLET | Prescription | ORAL |