Leqvio is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 20 US drug patents filed from 2022 to 2023. Out of these, 9 drug patents are active and 11 have expired. Leqvio's patents will be open to challenges from 22 December, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 25, 2036. Details of Leqvio'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. | |||
| US10125369 | PCSK9 iRNA compositions and methods of use thereof |
Aug, 2034
(9 years from now) | Active |
| US8106022 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(4 years from now) | Active |
| US8828956 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(3 years from now) | Active |
| US10806791 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(3 years from now) | Active |
| US9370582 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(3 years from now) | Active |
| US10131907 | Glycoconjugates of RNA interference agents |
Aug, 2028
(3 years from now) | Active |
| US8809292 | Compositions and methods for inhibiting expression of the PCSK9 gene |
May, 2027
(1 year, 11 months from now) | Active |
| US11530408 | Therapeutic compositions |
May, 2024
(11 months ago) |
Expired
|
| US10669544 | Therapeutic compositions |
Mar, 2024
(1 year, 2 months ago) |
Expired
|
| US9708615 | Therapeutic compositions |
Mar, 2024
(1 year, 2 months ago) |
Expired
|
| US10273477 | Therapeutic compositions |
Mar, 2024
(1 year, 2 months ago) |
Expired
|
| US9708610 | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Jan, 2024
(1 year, 4 months ago) |
Expired
|
| US11078485 | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Nov, 2023
(1 year, 6 months ago) |
Expired
|
| US8232383 | RNA interference mediated inhibition of gene expression using chemically modified short interfering nucleic acid (siNA) |
Feb, 2023
(2 years ago) |
Expired
|
| US8546143 | Compositions and methods for inhibiting expression of a target gene |
Apr, 2022
(3 years ago) |
Expired
|
| US9074213 | Compositions and methods for inhibiting expression of a target gene |
Mar, 2022
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10851377 | Methods and compositions for treating a proprotein convertase subtilisin kexin (PCSK9) gene-associated disorder |
Aug, 2036
(11 years from now) | Active |
| US8222222 | Compositions and methods for inhibiting expression of the PCSK9 gene |
Dec, 2027
(2 years from now) | Active |
| US10266825 | Compositions comprising alternating 2′-modified nucleosides for use in gene modulation |
Nov, 2023
(1 year, 6 months ago) |
Expired
|
| US10590418 | Methods and compositions for RNAi mediated inhibition of gene expression in mammals |
Jul, 2022
(2 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 Leqvio's patents.
Latest Legal Activities on Leqvio's Patents
Given below is the list of recent legal activities going on the following patents of Leqvio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jun, 2024 | US10806791 |
| Surcharge for Late Payment, Large Entity | 11 Jun, 2024 | US10806791 |
| Maintenance Fee Reminder Mailed Critical | 10 Jun, 2024 | US10806791 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jun, 2024 | US10851377 |
| Expire Patent Critical | 22 Apr, 2024 | US10590418 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8222222 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8809292 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US10125369 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8828956 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US9370582 |
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 Leqvio and ongoing litigations to help you estimate the early arrival of Leqvio generic.
Leqvio's Litigations
Leqvio been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 09, 2012, against patent number US10590418. The petitioner , challenged the validity of this patent, with Mark A. Kay et al as the respondent. Click below to track the latest information on how companies are challenging Leqvio's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10590418 | April, 2012 |
Decision
(04 Mar, 2015) | Mark A. Kay et al | |
FDA has granted some exclusivities to Leqvio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Leqvio, 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 Leqvio.
Exclusivity Information
Leqvio holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Leqvio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 22, 2026 |
Several oppositions have been filed on Leqvio'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 Leqvio's generic, the next section provides detailed information on ongoing and past EP oppositions related to Leqvio patents.
Leqvio's Oppositions Filed in EPO
Leqvio has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 20, 2003, by Sirna Therapeutics, Inc.. This opposition was filed on patent number EP00910510A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06025389A | Dec, 2017 | Silence Therapeutics GmbH | Revoked |
| EP10011217A | Apr, 2017 | Silence Therapeutics GmbH | Opposition rejected |
| EP10008929A | Oct, 2015 | Quark Pharmaceuticals, Inc. | Patent maintained as amended |
| EP10008931A | Jul, 2013 | Alnylam Pharmaceuticals Inc. | Opposition procedure closed |
| EP03716126A | Jul, 2013 | Alnylam Pharmaceuticals Inc. | Opposition procedure closed |
| EP10008930A | May, 2013 | Quark Pharmaceuticals, Inc. | Patent maintained as amended |
| EP10008930A | May, 2013 | Alnylam Pharmaceuticals Inc. | Patent maintained as amended |
| EP03743684A | Jun, 2011 | Alcon Research, Ltd. | Patent maintained as amended |
| EP03743684A | May, 2011 | Dharmacon, Inc. | Patent maintained as amended |
| EP03743684A | May, 2011 | Alnylam Pharmaceuticals Inc. | Patent maintained as amended |
| EP03743684A | May, 2011 | Novartis AG | Patent maintained as amended |
| EP03743684A | May, 2011 | Sanofi-Aventis Deutschland GmbH | Patent maintained as amended |
| EP02702247A | Dec, 2010 | Silence Therapeutics AG | Revoked |
| EP02702247A | Dec, 2010 | Sirna Therapeutics | Revoked |
| EP05002454A | Sep, 2009 | ROQUES, Sarah Elizabeth | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | Silence Therapeutics AG | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | PFIZER LIMITED | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | Sanofi-Aventis Deutschland GmbH | Granted and Under Opposition |
| EP05002454A | Sep, 2009 | Sirna Therapeutics | Granted and Under Opposition |
| EP02710786A | Feb, 2007 | Sirna Therapeutics | Opposition rejected |
| EP02003683A | Mar, 2006 | Abbott Laboratories | Patent maintained as amended |
| EP02003683A | Mar, 2006 | atugen AG | Patent maintained as amended |
| EP02003683A | Mar, 2006 | Quark Biotech, Inc. | Patent maintained as amended |
| EP02003683A | Mar, 2006 | Sirna Therapeutics, Inc. | Patent maintained as amended |
| EP00910510A | May, 2003 | Isis Pharmaceuticals, Inc. | Revoked |
| EP00910510A | May, 2003 | atugen AG | Revoked |
| EP00910510A | May, 2003 | Aventis Pharma Deutschland GmbH | Revoked |
| EP00910510A | May, 2003 | Grund, Martin, Dr. | Revoked |
| EP00910510A | May, 2003 | JANSSEN PHARMACEUTICA N.V. | Revoked |
| EP00910510A | May, 2003 | AstraZeneca AB | Revoked |
| EP00910510A | May, 2003 | Novartis AG | Revoked |
| EP00910510A | May, 2003 | Sirna Therapeutics, Inc. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Leqvio 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 Leqvio's family patents as well as insights into ongoing legal events on those patents.
Leqvio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Leqvio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 25, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Leqvio Generics:
There are no approved generic versions for Leqvio as of now.
About Leqvio
Leqvio is a drug owned by Novartis Pharmaceuticals Corp. It is used for reducing cholesterol levels in adults with certain genetic disorders or cardiovascular diseases by inhibiting the PCSK9 gene expression in combination with diet and statin therapy. Leqvio uses Inclisiran Sodium as an active ingredient. Leqvio was launched by Novartis in 2021.
Can you believe Leqvio 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:
Leqvio was approved by FDA for market use on 22 December, 2021.
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 Leqvio is 22 December, 2021, its NCE-1 date is estimated to be 22 December, 2025.
Active Ingredient:
Leqvio uses Inclisiran Sodium as the active ingredient. Check out other Drugs and Companies using Inclisiran Sodium ingredient
Treatment:
Leqvio is used for reducing cholesterol levels in adults with certain genetic disorders or cardiovascular diseases by inhibiting the PCSK9 gene expression in combination with diet and statin therapy.
Dosage:
Leqvio is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) | SOLUTION | Prescription | SUBCUTANEOUS |