Afinitor Disperz is a drug owned by Novartis Pharmaceutical Corp. It is protected by 10 US drug patents filed from 2013 to 2014 out of which all have expired. Afinitor Disperz's patents have been open to challenges since 29 April, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 10, 2025. Details of Afinitor Disperz'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). | |||
|
US8617598 (Pediatric) | Pharmaceutical compositions comprising colloidal silicon dioxide |
Mar, 2023
(1 year, 8 months ago) |
Expired
|
| US8617598 | Pharmaceutical compositions comprising colloidal silicon dioxide |
Sep, 2022
(2 years ago) |
Expired
|
|
US8778962 (Pediatric) | Treatment of solid tumors with rapamycin derivatives |
Aug, 2022
(2 years ago) |
Expired
|
| US8778962 | Treatment of solid tumors with rapamycin derivatives |
Feb, 2022
(2 years ago) |
Expired
|
|
US7297703 (Pediatric) | Macrolides |
Jun, 2020
(4 years ago) |
Expired
|
|
US5665772 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar, 2020
(4 years ago) |
Expired
|
| US7297703 | Macrolides |
Dec, 2019
(5 years ago) |
Expired
|
| US5665772 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep, 2019
(5 years ago) |
Expired
|
|
US6004973 (Pediatric) | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jan, 2017
(7 years ago) |
Expired
|
| US6004973 | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jul, 2016
(8 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 Disperz's patents.
Latest Legal Activities on Afinitor Disperz's Patents
Given below is the list of recent legal activities going on the following patents of Afinitor Disperz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Dec, 2021 | US8778962 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jun, 2021 | US8617598 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 May, 2019 | US7297703 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Jan, 2018 | US8778962 |
| Termination or Final Written Decision | 01 Apr, 2016 | US7297703 |
| Petition Requesting Trial | 26 Oct, 2015 | US7297703 |
| Post Issue Communication - Certificate of Correction | 14 May, 2015 | US7297703 |
| Recordation of Patent Grant Mailed Critical | 15 Jul, 2014 | US8778962 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Jul, 2014 | US8778962 |
| Issue Notification Mailed Critical | 25 Jun, 2014 | US8778962 |
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 Disperz and ongoing litigations to help you estimate the early arrival of Afinitor Disperz generic.
Afinitor Disperz's Litigations
Afinitor Disperz been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 26, 2015, against patent number US7297703. 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 Disperz's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5665772 | October, 2015 |
FWD Entered
(11 Jan, 2018) | Novartis AG | Par Pharmaceutical, 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. |
FDA has granted some exclusivities to Afinitor Disperz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Afinitor Disperz, 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 Disperz.
Exclusivity Information
Afinitor Disperz holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Afinitor Disperz'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 |
| Pediatric Exclusivity(PED) | Apr 29, 2018 |
| Orphan Drug Exclusivity(ODE) | Oct 29, 2017 |
| New Indication(I-773) | Apr 10, 2021 |
| Orphan Drug Exclusivity(ODE-169) | Apr 10, 2025 |
Several oppositions have been filed on Afinitor Disperz'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 Disperz's generic, the next section provides detailed information on ongoing and past EP oppositions related to Afinitor Disperz patents.
Afinitor Disperz's Oppositions Filed in EPO
Afinitor Disperz has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 18, 2016, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP10174983A. 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 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP16186041A | Sep, 2019 | Generics [UK] Ltd | Granted and Under Opposition |
| EP16186041A | Sep, 2019 | STADA Arzneimittel AG | 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 | Ethypharm | Revoked |
| EP14164565A | Dec, 2017 | Generics (U.K.) Limited | Revoked |
| EP10174985A | Apr, 2017 | Wittkopp, Alexander | Revoked |
| EP10174985A | Apr, 2017 | STADA Arzneimittel AG | Revoked |
| EP10174985A | Apr, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP10174985A | Apr, 2017 | Intas Pharmaceuticals Ltd. | Revoked |
| EP10174985A | Apr, 2017 | Generics [UK] 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 | Synthon B.V. | Revoked |
| EP10174983A | Feb, 2016 | Actavis PTC ehf | Revoked |
| EP10174983A | Feb, 2016 | Wittkopp, Alexander | Revoked |
| EP10174983A | Feb, 2016 | Intas Pharmaceuticals Ltd. | Revoked |
| EP10174983A | Feb, 2016 | STADA Arzneimittel AG | Revoked |
| EP10174983A | Feb, 2016 | Generics [UK] Limited | Revoked |
| EP10174983A | Feb, 2016 | Ethypharm | Revoked |
| EP10174983A | Feb, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
US patents provide insights into the exclusivity only within the United States, but Afinitor Disperz 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 Disperz's family patents as well as insights into ongoing legal events on those patents.
Afinitor Disperz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Afinitor Disperz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 10, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Afinitor Disperz Generic API suppliers:
Everolimus is the generic name for the brand Afinitor Disperz. 7 different companies have already filed for the generic of Afinitor Disperz, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Afinitor Disperz's generic
How can I launch a generic of Afinitor Disperz before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Afinitor Disperz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Afinitor Disperz'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 Disperz -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg, 3 mg and 5 mg | 30 Dec, 2016 | 1 | 19 Apr, 2019 | 27 Sep, 2022 | Eligible |
Alternative Brands for Afinitor Disperz
Afinitor Disperz which is used for managing partial-onset seizures associated with Tuberous Sclerosis Complex., 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Everolimus, Afinitor Disperz's active ingredient. Check the complete list of approved generic manufacturers for Afinitor Disperz
About Afinitor Disperz
Afinitor Disperz is a drug owned by Novartis Pharmaceutical Corp. It is used for managing partial-onset seizures associated with Tuberous Sclerosis Complex. Afinitor Disperz uses Everolimus as an active ingredient. Afinitor Disperz was launched by Novartis Pharm in 2012.
Can you believe Afinitor Disperz 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 Disperz was approved by FDA for market use on 29 August, 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 Afinitor Disperz is 29 August, 2012, its NCE-1 date is estimated to be 29 April, 2017.
Active Ingredient:
Afinitor Disperz uses Everolimus as the active ingredient. Check out other Drugs and Companies using Everolimus ingredient
Treatment:
Afinitor Disperz is used for managing partial-onset seizures associated with Tuberous Sclerosis Complex.
Dosage:
Afinitor Disperz is available in tablet, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG | TABLET, FOR SUSPENSION | Prescription | ORAL |
| 2MG | TABLET, FOR SUSPENSION | Prescription | ORAL |
| 5MG | TABLET, FOR SUSPENSION | Prescription | ORAL |