Invokamet is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2014 to 2023. Out of these, 5 drug patents are active and 1 has expired. Invokamet'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 Jul 06, 2030. Details of Invokamet'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). | |||
| US11576894 | Combination therapy for the treatment of diabetes |
Jul, 2030
(5 years from now) | Active |
| US8222219 | Glucopyranoside compound |
Apr, 2025
(3 months from now) | Active |
| US8785403 | Glucopyranoside compound |
Jul, 2024
(4 months 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 Invokamet's patents.
Latest Legal Activities on Invokamet's Patents
Given below is the list of recent legal activities going on the following patents of Invokamet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jan, 2024 | US8222219 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Feb, 2023 | US11576894 |
| Recordation of Patent Grant Mailed Critical | 14 Feb, 2023 | US11576894 |
| Email Notification Critical | 26 Jan, 2023 | US11576894 |
| Issue Notification Mailed Critical | 25 Jan, 2023 | US11576894 |
| Application Is Considered Ready for Issue Critical | 16 Dec, 2022 | US11576894 |
| Dispatch to FDC | 16 Dec, 2022 | US11576894 |
| Issue Fee Payment Received Critical | 15 Dec, 2022 | US11576894 |
| Issue Fee Payment Verified Critical | 15 Dec, 2022 | US11576894 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Nov, 2022 | US7943582 |
FDA has granted several exclusivities to Invokamet. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Invokamet, 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 Invokamet.
Exclusivity Information
Invokamet holds 5 exclusivities. All of its exclusivities have expired in 2021. Details of Invokamet's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Aug 08, 2017 |
| New Chemical Entity Exclusivity(NCE) | Mar 29, 2018 |
| New Indication(I-735) | May 20, 2019 |
| M(M-197) | Feb 01, 2020 |
| New Indication(I-788) | Oct 29, 2021 |
Several oppositions have been filed on Invokamet'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 Invokamet's generic, the next section provides detailed information on ongoing and past EP oppositions related to Invokamet patents.
Invokamet's Oppositions Filed in EPO
Invokamet 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 |
|---|---|---|---|
 | |||
| EP10735109A | Jan, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP10735109A | Jan, 2020 | Generics [UK] Limited | Granted and Under Opposition |
| EP14194507A | Jun, 2018 | Galenicum Health S.L. | Patent maintained as amended |
| EP14194507A | Jun, 2018 | Generics (UK) Ltd | Patent maintained as amended |
| 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 Invokamet 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 Invokamet's family patents as well as insights into ongoing legal events on those patents.
Invokamet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Invokamet's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 06, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Invokamet Generics:
There are no approved generic versions for Invokamet as of now.
How can I launch a generic of Invokamet before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Invokamet's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Invokamet'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 Invokamet -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg | 29 Mar, 2017 | 6 | 26 Feb, 2029 |
Alternative Brands for Invokamet
Invokamet which is used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients., has several other brand drugs in the same treatment category and using the same active ingredient (Canagliflozin; Metformin Hydrochloride). 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 |
| |||||||||
| Boehringer Ingelheim |
| |||||||||
| Cosette |
| |||||||||
| Janssen Pharms |
| |||||||||
| Sb Pharmco |
| |||||||||
About Invokamet
Invokamet is a drug owned by Janssen Pharmaceuticals Inc. It is used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients. Invokamet uses Canagliflozin; Metformin Hydrochloride as an active ingredient. Invokamet was launched by Janssen Pharms in 2014.
Approval Date:
Invokamet was approved by FDA for market use on 08 August, 2014.
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 Invokamet is 08 August, 2014, its NCE-1 date is estimated to be 29 March, 2017.
Active Ingredient:
Invokamet uses Canagliflozin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Canagliflozin; Metformin Hydrochloride ingredient
Treatment:
Invokamet is used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients.
Dosage:
Invokamet is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG;500MG | TABLET | Prescription | ORAL |
| 50MG;1GM | TABLET | Prescription | ORAL |
| 150MG;1GM | TABLET | Prescription | ORAL |
| 150MG;500MG | TABLET | Prescription | ORAL |