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, 3 drug patents are active and 11 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.

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
Critical Events for all Patents
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
Payment of Maintenance Fee, 8th Year, Large Entity	21 Oct, 2020	US8436010 (Litigated)
Termination or Final Written Decision	05 Oct, 2020	US9006224
Payment of Maintenance Fee, 8th Year, Large Entity	17 Sep, 2020	US8410131 (Litigated)
Termination or Final Written Decision	06 Jan, 2020	US8410131 (Litigated)

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., 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
Live updates
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	FWD Entered (11 Jan, 2018)	Novartis AG	Par Pharmaceutical, Inc.
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	Terminated-Denied (13 Feb, 2017)	Novartis AG	Roxane Laboratories, Inc.
US5665772	May, 2016	FWD Entered (27 Oct, 2016)	Novartis AG	BRECKENRIDGE PHARMACEUTICAL, INC.
US5665772	May, 2016	Terminated-Denied (27 Oct, 2016)	Novartis AG	Par Pharmaceutical, Inc.
US5665772	May, 2016	FWD Entered (27 Oct, 2016)	Novartis AG	Roxane Laboratories, Inc.
US5665772	May, 2016	Terminated-Denied (27 Oct, 2016)	Novartis AG	Breckenridge Pharmaceutical, Inc.
US7297703	October, 2015	Terminated-Denied (01 Apr, 2016)	Novartis AG	Par Pharmaceutical, Inc.
US7741338	October, 2015	Terminated-Denied (01 Apr, 2016)	Novartis AG	Par Pharmaceutical, Inc.

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.

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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
Live updates
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

Afinitor has patent protection in a total of 31 countries. It's US patent count contributes only to 6.7% of its total global patent coverage. 8 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 Afinitor.

Full family tree

Generic Launch

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.