Invokana is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2013 to 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 11, 2031. Details of Invokana'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. | |||
| US7943788 | Glucopyranoside compound |
Jul, 2027
(2 years from now) | Active |
| US8513202 | Crystalline form of 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate |
Dec, 2027
(3 years from now) | Active |
| US7943582 | Crystalline form of 1-(β-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate |
Feb, 2029
(4 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). | |||
| US8222219 | Glucopyranoside compound |
Apr, 2025
(8 months from now) | Active |
| US10617668 | Pharmaceutical formulations |
May, 2031
(6 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 Invokana's patents.
Latest Legal Activities on Invokana's Patents
Given below is the list of recent legal activities going on the following patents of Invokana.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 20 May, 2024 | US10617668 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jan, 2024 | US8222219 |
| Maintenance Fee Reminder Mailed | 04 Dec, 2023 | US10617668 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Nov, 2022 | US7943582 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Nov, 2022 | US7943788 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Feb, 2021 | US8513202 |
| Patent Issue Date Used in PTA Calculation | 14 Apr, 2020 | US10617668 |
| Recordation of Patent Grant Mailed | 14 Apr, 2020 | US10617668 |
| Email Notification | 26 Mar, 2020 | US10617668 |
| Issue Notification Mailed | 25 Mar, 2020 | US10617668 |
FDA has granted several exclusivities to Invokana. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Invokana, 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 Invokana.
Exclusivity Information
Invokana holds 5 exclusivities. All of its exclusivities have expired in 2022. Details of Invokana's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 29, 2018 |
| New Indication(I-733) | May 20, 2019 |
| M(M-197) | Feb 01, 2020 |
| New Indication(I-788) | Oct 29, 2021 |
| New Indication(I-809) | Sep 27, 2022 |
Several oppositions have been filed on Invokana'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 Invokana's generic, the next section provides detailed information on ongoing and past EP oppositions related to Invokana patents.
Invokana's oppositions filed in EPO
Invokana has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 16, 2013, by Galenicum Health S.L.. This opposition was filed on patent number EP04771314A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14194507A | Jun, 2018 | Galenicum Health S.L. | Patent maintained as amended |
| EP14194507A | Jun, 2018 | Generics (UK) Ltd | Patent maintained as amended |
| EP11721616A | Apr, 2017 | LEK Pharmaceuticals d.d. | Revoked |
| EP07850306A | Nov, 2014 | Galenicum Health S.L. | Patent maintained as amended |
| EP04771314A | Oct, 2013 | Galenicum Health S.L. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Invokana 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 Invokana's family patents as well as insights into ongoing legal events on those patents.
Invokana's family patents
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Generic Launch
Generic Release Date:
Invokana's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 11, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Invokana Generics:
There are no approved generic versions for Invokana as of now.
How can I launch a generic of Invokana before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Invokana's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Invokana'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 Invokana -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 300 mg | 29 Mar, 2017 | 10 | 26 Feb, 2029 |
About Invokana
Invokana is a drug owned by Janssen Pharmaceuticals Inc. It is used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks. Invokana uses Canagliflozin as an active ingredient. Invokana was launched by Janssen Pharms in 2013.
Market Authorisation Date:
Invokana was approved by FDA for market use on 29 March, 2013.
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 Invokana is 29 March, 2013, its NCE-1 date is estimated to be 29 March, 2017
Active Ingredient:
Invokana uses Canagliflozin as the active ingredient. Check out other Drugs and Companies using Canagliflozin ingredient
Treatment:
Invokana is used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks.
Dosage:
Invokana is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |