Synjardy Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 17 US drug patents filed from 2016 to 2023. Out of these, 16 drug patents are active and 1 has expired. Synjardy Xr's patents will be open to challenges from 20 December, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2034. Details of Synjardy 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. | |||
| US7579449 | Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture |
Aug, 2028
(3 years from now) | Active |
| US7713938 | Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments |
Apr, 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). | |||
|
US9949998 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Dec, 2034
(9 years from now) | Active |
|
US9949997 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Nov, 2034
(9 years from now) | Active |
|
US10258637 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
|
US11090323 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
| US9949998 | Pharmaceutical composition, methods for treating and uses thereof |
Jun, 2034
(9 years from now) | Active |
| US9949997 | Pharmaceutical composition, methods for treating and uses thereof |
May, 2034
(9 years from now) | Active |
| US11833166 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US10258637 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11813275 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11090323 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
|
US10596120 (Pediatric) | Pharmaceutical compositions |
Sep, 2032
(7 years from now) | Active |
| US10596120 | Pharmaceutical compositions |
Mar, 2032
(7 years from now) | Active |
|
US7579449 (Pediatric) | Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture |
Feb, 2029
(4 years from now) | Active |
|
US7713938 (Pediatric) | Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments |
Oct, 2027
(2 years from now) | Active |
| US6488962 | Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms |
Jun, 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 Synjardy Xr's patents.
Latest Legal Activities on Synjardy Xr's Patents
Given below is the list of recent legal activities going on the following patents of Synjardy Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Sep, 2023 | US10596120 |
| Recordation of Patent Grant Mailed Critical | 24 Mar, 2020 | US10596120 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Mar, 2020 | US10596120 |
| Correspondence Address Change Critical | 12 Mar, 2020 | US10596120 |
| Issue Notification Mailed Critical | 04 Mar, 2020 | US10596120 |
| Correspondence Address Change Critical | 25 Feb, 2020 | US10596120 |
| Dispatch to FDC | 14 Jan, 2020 | US10596120 |
| Issue Fee Payment Verified Critical | 02 Jan, 2020 | US10596120 |
| Issue Fee Payment Received Critical | 02 Jan, 2020 | US10596120 |
| Electronic Review Critical | 23 Dec, 2019 | US10596120 |
FDA has granted several exclusivities to Synjardy Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Synjardy 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 Synjardy Xr.
Exclusivity Information
Synjardy Xr holds 4 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Synjardy Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 01, 2019 |
| New Indication(I-739) | Dec 02, 2019 |
| M(M-296) | Jun 20, 2026 |
| Pediatric Exclusivity(PED) | Dec 20, 2026 |
Several oppositions have been filed on Synjardy 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 Synjardy Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Synjardy Xr patents.
Synjardy Xr's Oppositions Filed in EPO
Synjardy Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 02, 2019, by Krka, D.D., Novo Mesto. This opposition was filed on patent number EP14715578A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14715274A | Apr, 2023 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Gillard, Richard Edward | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | EGIS Gyógyszergyár Zártkörüen Müködö Részvénytársaság | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | KRKA, d.d., Novo mesto | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Synjardy 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 Synjardy Xr's family patents as well as insights into ongoing legal events on those patents.
Synjardy Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Synjardy Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Synjardy Xr Generic API suppliers:
Empagliflozin; Metformin Hydrochloride is the generic name for the brand Synjardy Xr. 1 company has already filed for the generic of Synjardy Xr. Check out the entire list of companies who have already received approval for Synjardy Xr's generic
How can I launch a generic of Synjardy Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Synjardy Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Synjardy 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 Synjardy Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg | 01 Aug, 2018 | 3 | 11 Jun, 2034 |
Alternative Brands for Synjardy Xr
Synjardy Xr which is used for improving cardiovascular outcomes and managing type 2 diabetes, including in patients with renal impairment, by administering empagliflozin in combination with other medications., has several other brand drugs in the same treatment category and using the same active ingredient (Empagliflozin; 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim |
| |||||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Empagliflozin; Metformin Hydrochloride, Synjardy Xr's active ingredient. Check the complete list of approved generic manufacturers for Synjardy Xr
About Synjardy Xr
Synjardy Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for improving cardiovascular outcomes and managing type 2 diabetes, including in patients with renal impairment, by administering empagliflozin in combination with other medications. Synjardy Xr uses Empagliflozin; Metformin Hydrochloride as an active ingredient. Synjardy Xr was launched by Boehringer Ingelheim in 2016.
Approval Date:
Synjardy Xr was approved by FDA for market use on 09 December, 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 Synjardy Xr is 09 December, 2016, its NCE-1 date is estimated to be 20 December, 2025.
Active Ingredient:
Synjardy Xr uses Empagliflozin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Empagliflozin; Metformin Hydrochloride ingredient
Treatment:
Synjardy Xr is used for improving cardiovascular outcomes and managing type 2 diabetes, including in patients with renal impairment, by administering empagliflozin in combination with other medications.
Dosage:
Synjardy Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 10MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 25MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |