Invokamet Xr is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2016 to 2024. Out of these, 6 drug patents are active and 4 have expired. Invokamet Xr's patents will be open to challenges from 19 June, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 26, 2029. Details of Invokamet Xr'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
(3 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
(1 year, 8 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7943582 (Pediatric) | Crystalline form of 1-(β-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate |
Aug, 2029
(3 years from now) | Active |
|
US8513202 (Pediatric) | Crystalline form of 1-(beta-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate |
Jun, 2028
(2 years from now) | Active |
|
US7943788 (Pediatric) | Glucopyranoside compound |
Jan, 2028
(2 years from now) | Active |
|
US8222219 (Pediatric) | Glucopyranoside compound |
Oct, 2025
(13 days ago) |
Expired
|
| US8222219 | Glucopyranoside compound |
Apr, 2025
(6 months ago) |
Expired
|
| US8785403 | Glucopyranoside compound |
Jul, 2024
(1 year, 2 months ago) |
Expired
|
| US6723340 | Optimal polymer mixtures for gastric retentive tablets |
Oct, 2021
(4 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 Invokamet Xr's patents.
Latest Legal Activities on Invokamet Xr's Patents
Given below is the list of recent legal activities going on the following patents of Invokamet Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jan, 2024 | US8222219 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Nov, 2022 | US7943788 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Nov, 2022 | US7943582 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jan, 2022 | US8785403 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Feb, 2021 | US8513202 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2020 | US8222219 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Nov, 2018 | US7943582 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Nov, 2018 | US7943788 |
| Review Certificate Mailed | 26 Jul, 2018 | US6723340 (Litigated) |
| Review Certificate | 09 Jul, 2018 | US6723340 (Litigated) |
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 Invokamet Xr and ongoing
litigations to
help you estimate the early arrival of Invokamet Xr generic.
Invokamet Xr's Litigations
Invokamet Xr been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 17, 2014, against patent number US6723340. The petitioner Endo Pharmaceutical Inc. et al., challenged the validity of this patent, with DepoMed, Inc. as the respondent. Click below to track the latest information on how companies are challenging Invokamet Xr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6723340 | April, 2014 |
Final Written Decision
(16 Sep, 2015) | DepoMed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6723340 | April, 2014 |
Institution Denied
(29 Sep, 2014) | DepoMed, Inc. | Endo Pharmaceutical Inc. et al. |
FDA has granted some exclusivities to Invokamet Xr. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Invokamet Xr,
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 Xr.
Exclusivity Information
Invokamet Xr holds 6 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Invokamet Xr'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 |
| New Indication(I-788) | Oct 29, 2021 |
| New Patient Population(NPP) | Dec 18, 2027 |
| Pediatric Exclusivity(PED) | Jun 18, 2028 |
Several oppositions have been filed on Invokamet Xr'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 Xr's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Invokamet Xr patents.
Invokamet Xr's Oppositions Filed in EPO
Invokamet Xr 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 |
| 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 Xr 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 Xr's family patents as well as insights into
ongoing legal events
on those patents.
Invokamet Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Invokamet Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 26, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Invokamet Xr Generics:
There are no approved generic versions for Invokamet Xr as of now.
How can I launch a generic of Invokamet Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Invokamet Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Invokamet Xr'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 Xr -
| 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 | 21 Nov, 2018 | 1 | 26 Feb, 2029 |
Alternative Brands for Invokamet Xr
Invokamet Xr which is used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure., 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 Xr
Invokamet Xr is a drug owned by Janssen Pharmaceuticals Inc. It is used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure. Invokamet Xr uses Canagliflozin; Metformin Hydrochloride as an active ingredient. Invokamet Xr was launched by Janssen Pharms in 2016.
Approval Date:
Invokamet Xr was approved by FDA for market use on 20 September, 2016.
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 Xr is 20 September, 2016, its NCE-1 date is estimated to be 19 June, 2027.
Active Ingredient:
Invokamet Xr uses Canagliflozin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Canagliflozin; Metformin Hydrochloride ingredient
Treatment:
Invokamet Xr is used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure.
Dosage:
Invokamet Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 50MG;500MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 150MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 150MG;500MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |