Gilenya is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 10 US drug patents filed from 2013 to 2020. Out of these, 7 drug patents are active and 3 have expired. Gilenya's patents have been open to challenges since 11 November, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 30, 2032. Details of Gilenya'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. | |||
| US5604229 | 2-amino-1,3-propanediol compound and immunosuppressant |
Feb, 2019
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9592208 (Pediatric) | Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol |
Sep, 2032
(7 years from now) | Active |
| US9592208 | Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol |
Mar, 2032
(7 years from now) | Active |
| US10543179 | Dosage regimen of an S1P receptor modulator |
Dec, 2027
(3 years from now) | Active |
|
US9187405 (Pediatric) | S1P receptor modulators for treating relasping-remitting multiple sclerosis |
Dec, 2027
(3 years from now) | Active |
| US9187405 | S1P receptor modulators for treating relasping-remitting multiple sclerosis |
Jun, 2027
(2 years from now) | Active |
|
US8324283 (Pediatric) | Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol |
Sep, 2026
(1 year, 9 months from now) | Active |
| US8324283 | Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol |
Mar, 2026
(1 year, 3 months from now) | Active |
|
US5604229 (Pediatric) | 2-amino-1,3-propanediol compound and immunosuppressant |
Aug, 2019
(5 years ago) |
Expired
|
| US6004565 | Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties |
Sep, 2017
(7 years ago) |
Expired
|
| US5604229 | 2-amino-1,3-propanediol compound and immunosuppressant |
Feb, 2014
(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 Gilenya's patents.
Latest Legal Activities on Gilenya's Patents
Given below is the list of recent legal activities going on the following patents of Gilenya.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Jul, 2023 | US10543179 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 May, 2023 | US9187405 (Litigated) |
| Expire Patent Critical | 11 Jan, 2021 | US8324283 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Sep, 2020 | US9592208 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 27 Jul, 2020 | US8324283 (Litigated) |
| Review Certificate Mailed | 10 Feb, 2020 | US9187405 (Litigated) |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 04 Feb, 2020 | US10543179 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 28 Jan, 2020 | US10543179 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 28 Jan, 2020 | US10543179 (Litigated) |
| Paralegal TD Not accepted | 27 Jan, 2020 | US10543179 (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 Gilenya and ongoing litigations to help you estimate the early arrival of Gilenya generic.
Gilenya's Litigations
Gilenya been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 31, 2014, against patent number US8324283. The petitioner Apotex, Inc. et al., challenged the validity of this patent, with Novartis AG et al. as the respondent. Click below to track the latest information on how companies are challenging Gilenya's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9187405 | August, 2017 |
FWD Entered
(07 Aug, 2018) | Novartis Pharmaceuticals Corporation | Actavis Elizabeth LLC |
| US9187405 | August, 2017 |
Terminated
(07 Aug, 2018) | Novartis Pharmaceuticals Corporation | Sun Pharmaceutical Industries, Ltd. et al. |
| US9187405 | February, 2017 |
FWD Entered
(11 Jul, 2018) | Novartis AG | Apotex Inc. |
| US9187405 | June, 2017 |
FWD Entered
(17 Aug, 2017) | Novartis AG | Argentum Pharmaceuticals LLC |
| US8324283 | May, 2014 |
FWD Entered
(24 Sep, 2015) | Novartis AG | TORRENT PHARMACEUTICALS LIMITED |
| US8324283 | December, 2014 |
Final Written Decision
(24 Sep, 2015) | Novartis AG et al. | Apotex, Inc. et al. |
FDA has granted some exclusivities to Gilenya. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gilenya, 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 Gilenya.
Exclusivity Information
Gilenya holds 5 exclusivities. All of its exclusivities have expired in 2021. Details of Gilenya's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-106) | Jul 20, 2014 |
| New Chemical Entity Exclusivity(NCE) | Sep 21, 2015 |
| New Patient Population(NPP) | May 11, 2021 |
| New Strength(NS) | May 11, 2021 |
| Pediatric Exclusivity(PED) | Nov 11, 2021 |
Several oppositions have been filed on Gilenya'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 Gilenya's generic, the next section provides detailed information on ongoing and past EP oppositions related to Gilenya patents.
Gilenya's Oppositions Filed in EPO
Gilenya has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 12, 2022, by Generics [Uk] Limited. This opposition was filed on patent number EP15177166A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP15177166A | May, 2023 | Synthon BV | Granted and Under Opposition |
| EP15177166A | May, 2023 | Wuesthoff & Wuesthoff Patentanwälte PartG mbB | Granted and Under Opposition |
| EP15177166A | Mar, 2023 | neuraxpharm Arzneimittel GmbH | Granted and Under Opposition |
| EP15177166A | Jan, 2023 | Dr. Schön, Neymeyr & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP15177166A | Jan, 2023 | BIOGARAN | Granted and Under Opposition |
| EP15177166A | Jan, 2023 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP15177166A | Jan, 2023 | Bausch Health Ireland Limited | Granted and Under Opposition |
| EP15177166A | Dec, 2022 | Vivanta Generics s.r.o. / MSN Labratories Private Ltd. | Granted and Under Opposition |
| EP15177166A | Dec, 2022 | Heumann Pharma GmbH & Co. Generica KG | Granted and Under Opposition |
| EP15177166A | Dec, 2022 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP15177166A | Nov, 2022 | A-med GmbH | Granted and Under Opposition |
| EP15177166A | Nov, 2022 | RAFARM S.A. | Granted and Under Opposition |
| EP15177166A | Nov, 2022 | Genepharm S.A. | Granted and Under Opposition |
| EP15177166A | Oct, 2022 | Elpen Pharmaceutical Co. Inc. | Granted and Under Opposition |
| EP15177166A | Oct, 2022 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP15177166A | Oct, 2022 | Glenmark Pharmaceuticals Europe Ltd. | Granted and Under Opposition |
| EP15177166A | Oct, 2022 | PHARMATHEN S.A. | Granted and Under Opposition |
| EP15177166A | Oct, 2022 | Zentiva k.s. | Granted and Under Opposition |
| EP15177166A | Oct, 2022 | Generics [UK] Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Gilenya 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 Gilenya's family patents as well as insights into ongoing legal events on those patents.
Gilenya's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gilenya's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 30, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gilenya Generic API suppliers:
Fingolimod Hydrochloride is the generic name for the brand Gilenya. 17 different companies have already filed for the generic of Gilenya, with Teva Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gilenya's generic
How can I launch a generic of Gilenya before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gilenya's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gilenya'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 Gilenya -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg | 22 Sep, 2014 | 19 | 04 Dec, 2019 | 29 Mar, 2026 | Deferred |
| 0.25 mg | 19 Jul, 2018 | 1 | 12 Nov, 2021 | 30 Mar, 2032 | Eligible |
About Gilenya
Gilenya is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating autoimmune diseases and multiple sclerosis, including relapsing-remitting and pediatric patients. Gilenya uses Fingolimod Hydrochloride as an active ingredient. Gilenya was launched by Novartis in 2018.
Approval Date:
Gilenya was approved by FDA for market use on 11 May, 2018.
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 Gilenya is 11 May, 2018, its NCE-1 date is estimated to be 11 November, 2020.
Active Ingredient:
Gilenya uses Fingolimod Hydrochloride as the active ingredient. Check out other Drugs and Companies using Fingolimod Hydrochloride ingredient
Treatment:
Gilenya is used for treating autoimmune diseases and multiple sclerosis, including relapsing-remitting and pediatric patients.
Dosage:
Gilenya is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.25MG BASE | CAPSULE | Prescription | ORAL |
| EQ 0.5MG BASE | CAPSULE | Prescription | ORAL |