Invokana Patent Expiration

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. Invokana's patents have been open to challenges since 29 March, 2017. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
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
US8513202 Crystalline form of 1-(β-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate
Dec, 2027

(2 years from now)

Active
US7943788 Glucopyranoside compound
Jul, 2027

(2 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10617668 Pharmaceutical formulations
May, 2031

(6 years from now)

Active
US8222219 Glucopyranoside compound
Apr, 2025

(3 months 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.

Given below is the list of recent legal activities going on the following patents of Invokana.

Activity Date Patent Number
Patent litigations
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

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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
Patent litigations
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

Invokana has patent protection in a total of 48 countries. It's US patent count contributes only to 18.1% of its total global patent coverage. 14 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Invokana.

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

Alternative Brands for Invokana

Invokana which is used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks., has several other brand drugs in the same treatment category and using the same active ingredient (Canagliflozin). 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.

Drug Owner Drug Name Treatment Area
Astrazeneca Ab
Qtern Used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin.
Farxiga used for treating heart failure and type 2 diabetes.
Xigduo Xr used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications.
Qternmet Xr Used for managing blood sugar levels in individuals with type 2 diabetes mellitus.
Boehringer Ingelheim
Tradjenta Used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control.
Cosette
Welchol Used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels.
Janssen Pharms
Invokamet

(uses Canagliflozin)

Used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients.
Invokamet Xr

(uses Canagliflozin)

used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure.
Sb Pharmco
Avandamet Used for managing and treating type 2 diabetes mellitus.





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.

Approval Date:

Invokana was approved by FDA for market use on 29 March, 2013.

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 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