Xigduo Xr is a drug owned by Astrazeneca Ab. It is protected by 13 US drug patents filed from 2014 to 2024. Out of these, 10 drug patents are active and 3 have expired. Xigduo Xr's patents will be open to challenges from 12 December, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be May 12, 2031. Details of Xigduo 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. | |||
| US7919598 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Dec, 2029
(5 years from now) | Active |
| US6515117 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2025
(11 months from now) | Active |
| US6414126 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9616028 (Pediatric) | Bilayer tablet formulations |
May, 2031
(6 years from now) | Active |
|
US8685934 (Pediatric) | Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof |
Nov, 2030
(6 years from now) | Active |
| US9616028 | Bilayer tablet formulations |
Nov, 2030
(6 years from now) | Active |
|
US7919598 (Pediatric) | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Jun, 2030
(5 years from now) | Active |
| US8685934 | Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof |
May, 2030
(5 years from now) | Active |
|
US8501698 (Pediatric) | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Dec, 2027
(3 years from now) | Active |
| US8501698 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Jun, 2027
(2 years from now) | Active |
|
US6515117 (Pediatric) | C-aryl glucoside SGLT2 inhibitors and method |
Apr, 2026
(1 year, 5 months from now) | Active |
| US9198925 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Oct, 2020
(4 years ago) |
Expired
|
| US6936590 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2020
(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 Xigduo Xr's patents.
Latest Legal Activities on Xigduo Xr's Patents
Given below is the list of recent legal activities going on the following patents of Xigduo Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Sep, 2020 | US9616028 |
| Recordation of Patent Grant Mailed Critical | 11 Apr, 2017 | US9616028 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Apr, 2017 | US9616028 |
| Email Notification Critical | 23 Mar, 2017 | US9616028 |
| Issue Notification Mailed Critical | 22 Mar, 2017 | US9616028 |
| Dispatch to FDC | 02 Mar, 2017 | US9616028 |
| Application Is Considered Ready for Issue Critical | 02 Mar, 2017 | US9616028 |
| Issue Fee Payment Verified Critical | 24 Feb, 2017 | US9616028 |
| Issue Fee Payment Received Critical | 24 Feb, 2017 | US9616028 |
| Electronic Review Critical | 28 Nov, 2016 | US9616028 |
FDA has granted several exclusivities to Xigduo Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xigduo 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 Xigduo Xr.
Exclusivity Information
Xigduo Xr holds 5 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Xigduo Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 08, 2019 |
| M(M-238) | Feb 22, 2022 |
| New Indication(I-841) | Oct 18, 2022 |
| New Patient Population(NPP) | Jun 12, 2027 |
| Pediatric Exclusivity(PED) | Dec 12, 2027 |
Several oppositions have been filed on Xigduo 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 Xigduo Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xigduo Xr patents.
Xigduo Xr's Oppositions Filed in EPO
Xigduo Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2015, by Lek Pharmaceuticals D.D.. This opposition was filed on patent number EP07784499A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17203302A | Aug, 2020 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10782113A | Apr, 2019 | Hoefer & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP15181545A | Sep, 2018 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP07784499A | Apr, 2015 | LEK Pharmaceuticals d.d. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Xigduo 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 Xigduo Xr's family patents as well as insights into ongoing legal events on those patents.
Xigduo Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xigduo Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 12, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xigduo Xr Generics:
There are no approved generic versions for Xigduo Xr as of now.
How can I launch a generic of Xigduo Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xigduo Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xigduo 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 Xigduo Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/1000 mg | 29 Oct, 2018 | 1 | 16 Dec, 2029 | ||
| 5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg | 08 Jan, 2018 | 10 | 26 May, 2030 |
Alternative Brands for Xigduo Xr
Xigduo Xr which is used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications., has several other brand drugs in the same treatment category and using the same active ingredient (Dapagliflozin; 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 |
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| Janssen Pharms |
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| Sb Pharmco |
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About Xigduo Xr
Xigduo Xr is a drug owned by Astrazeneca Ab. It is used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications. Xigduo Xr uses Dapagliflozin; Metformin Hydrochloride as an active ingredient. Xigduo Xr was launched by Astrazeneca Ab in 2017.
Approval Date:
Xigduo Xr was approved by FDA for market use on 28 July, 2017.
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 Xigduo Xr is 28 July, 2017, its NCE-1 date is estimated to be 12 December, 2026.
Active Ingredient:
Xigduo Xr uses Dapagliflozin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dapagliflozin; Metformin Hydrochloride ingredient
Treatment:
Xigduo Xr is used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications.
Dosage:
Xigduo Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;500MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 10MG;500MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 10MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 2.5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |