Invokamet Xr Patent Expiration

Invokamet Xr is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 6 US drug patents filed in 2016. Out of these, 4 drug patents are active and 2 have expired. Invokamet Xr'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 Feb 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

(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

(3 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).
US8222219 Glucopyranoside compound
Apr, 2025

(5 months from now)

Active
US8785403 Glucopyranoside compound
Jul, 2024

(2 months ago)

Expired
US6723340 Optimal polymer mixtures for gastric retentive tablets
Oct, 2021

(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 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
Patent litigations
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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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 4 exclusivities. All of its exclusivities have expired in 2021. 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

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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
Patent litigations
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

Invokamet Xr has patent protection in a total of 46 countries. It's US patent count contributes only to 19.4% 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 Invokamet Xr.

Family Patents

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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 Feb 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
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
Invokana used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks.
Invokamet

(uses Canagliflozin; Metformin Hydrochloride)

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





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 29 March, 2017.

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
150MG;1GM TABLET, EXTENDED RELEASE Prescription ORAL
150MG;500MG TABLET, EXTENDED RELEASE Prescription ORAL
50MG;500MG TABLET, EXTENDED RELEASE Prescription ORAL
50MG;1GM TABLET, EXTENDED RELEASE Prescription ORAL