Lenvima is a drug owned by Eisai Inc. It is protected by 14 US drug patents filed from 2015 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 23, 2036. Details of Lenvima's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7253286 | Nitrogen-containing aromatic derivatives |
Oct, 2025
(1 year, 2 months from now) | Active |
| US7612208 | Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt and a process for preparing the same |
Sep, 2026
(2 years from now) | Active |
| US10259791 | High-purity quinoline derivative and method for manufacturing same |
Aug, 2035
(11 years from now) | Active |
| US10407393 | High-purity quinoline derivative and method for manufacturing same |
Aug, 2035
(11 years from now) | Active |
| US11186547 | High-purity quinoline derivative and method for manufacturing same |
Aug, 2035
(11 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7253286 (Pediatric) | Nitrogen-containing aromatic derivatives |
Apr, 2026
(1 year, 8 months from now) | Active |
|
US7612208 (Pediatric) | Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt and a process for preparing the same |
Mar, 2027
(2 years from now) | Active |
| US9006256 | Antitumor agent for thyroid cancer |
Jul, 2027
(2 years from now) | Active |
|
US9006256 (Pediatric) | Antitumor agent for thyroid cancer |
Jan, 2028
(3 years from now) | Active |
| US11090386 | Method for suppressing bitterness of quinoline derivative |
Feb, 2036
(11 years from now) | Active |
|
US11186547 (Pediatric) | High-purity quinoline derivative and method for manufacturing same |
Feb, 2036
(11 years from now) | Active |
|
US10407393 (Pediatric) | High-purity quinoline derivative and method for manufacturing same |
Feb, 2036
(11 years from now) | Active |
|
US10259791 (Pediatric) | High-purity quinoline derivative and method for manufacturing same |
Feb, 2036
(11 years from now) | Active |
|
US11090386 (Pediatric) | Method for suppressing bitterness of quinoline derivative |
Aug, 2036
(12 years from now) | Active |
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 Lenvima's patents.
Latest Legal Activities on Lenvima's Patents
Given below is the list of recent legal activities going on the following patents of Lenvima.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Mar, 2023 | US10407393 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Oct, 2022 | US10259791 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Oct, 2022 | US9006256 |
| Patent Issue Date Used in PTA Calculation | 30 Nov, 2021 | US11186547 |
| Recordation of Patent Grant Mailed | 30 Nov, 2021 | US11186547 |
| Email Notification | 11 Nov, 2021 | US11186547 |
| Issue Notification Mailed | 10 Nov, 2021 | US11186547 |
| Mailing Corrected Notice of Allowability | 04 Nov, 2021 | US11186547 |
| Email Notification | 04 Nov, 2021 | US11186547 |
| Application Is Considered Ready for Issue | 03 Nov, 2021 | US11186547 |
FDA has granted several exclusivities to Lenvima. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lenvima, 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 Lenvima.
Exclusivity Information
Lenvima holds 12 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Lenvima's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-734) | May 13, 2019 |
| New Chemical Entity Exclusivity(NCE) | Feb 13, 2020 |
| New Indication(I-787) | Aug 15, 2021 |
| Orphan Drug Exclusivity(ODE-87) | Feb 13, 2022 |
| Orphan Drug Exclusivity(ODE) | Feb 13, 2022 |
| New Indication(I-807) | Sep 17, 2022 |
| M(M-269) | Jul 21, 2024 |
| New Indication(I-868) | Aug 10, 2024 |
| M(M-272) | Dec 19, 2024 |
| Orphan Drug Exclusivity(ODE-196) | Aug 15, 2025 |
| M(M-14) | Apr 03, 2027 |
| Pediatric Exclusivity(PED) | Oct 03, 2027 |
Several oppositions have been filed on Lenvima'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 Lenvima's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lenvima patents.
Lenvima's oppositions filed in EPO
Lenvima has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 18, 2016, by Actavis Group Ptc Ehf. This opposition was filed on patent number EP07743994A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19151846A | May, 2023 | Welding GmbH & Co. KG | Granted and Under Opposition |
| EP19151846A | May, 2023 | Accord Healthcare | Granted and Under Opposition |
| EP19151846A | May, 2023 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP19151846A | May, 2023 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP19151846A | May, 2023 | Aechter, Bernd | Granted and Under Opposition |
| EP19151846A | May, 2023 | Maiwald GmbH | Granted and Under Opposition |
| EP19151846A | May, 2023 | Hansen, Norbert | Granted and Under Opposition |
| EP19151846A | May, 2023 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP19151846A | May, 2023 | ELKINGTON AND FIFE LLP | Granted and Under Opposition |
| EP07743994A | Jul, 2016 | Generics [UK] Ltd (trading as Mylan) | Revoked |
| EP07743994A | Jul, 2016 | Actavis Group PTC ehf | Revoked |
US patents provide insights into the exclusivity only within the United States, but Lenvima 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 Lenvima's family patents as well as insights into ongoing legal events on those patents.
Lenvima's family patents
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Generic Launch
Generic Release Date:
Lenvima's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 23, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lenvima Generics:
There are no approved generic versions for Lenvima as of now.
How can I launch a generic of Lenvima before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lenvima's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lenvima'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 Lenvima -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 4 mg and 10 mg | 13 Feb, 2019 | 2 | 27 Jul, 2027 |
About Lenvima
Lenvima is a drug owned by Eisai Inc. It is used for treating thyroid carcinoma, including differentiated thyroid cancer, by administering Lenvima as a suspension. Lenvima uses Lenvatinib Mesylate as an active ingredient. Lenvima was launched by Eisai Inc in 2015.
Market Authorisation Date:
Lenvima was approved by FDA for market use on 13 February, 2015.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Lenvima is 13 February, 2015, its NCE-1 date is estimated to be 03 October, 2026
Active Ingredient:
Lenvima uses Lenvatinib Mesylate as the active ingredient. Check out other Drugs and Companies using Lenvatinib Mesylate ingredient
Treatment:
Lenvima is used for treating thyroid carcinoma, including differentiated thyroid cancer, by administering Lenvima as a suspension.
Dosage:
Lenvima is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4MG BASE | CAPSULE | Prescription | ORAL |
| EQ 10MG BASE | CAPSULE | Prescription | ORAL |