Synjardy is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 14 US drug patents filed from 2015 to 2023 out of which none have expired yet. Synjardy'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 Nov 17, 2034. Details of Synjardy'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). | |||
|
US9949997 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Nov, 2034
(9 years from now) | Active |
|
US11090323 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
|
US10258637 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
| US9949997 | Pharmaceutical composition, methods for treating and uses thereof |
May, 2034
(9 years from now) | Active |
| US11090323 | 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 |
| US11833166 | 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 |
|
US10610489 (Pediatric) | Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof |
Mar, 2031
(6 years from now) | Active |
| US10610489 | Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof |
Sep, 2030
(5 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 |
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's patents.
Latest Legal Activities on Synjardy's Patents
Given below is the list of recent legal activities going on the following patents of Synjardy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Sep, 2023 | US10610489 |
| Recordation of Patent Grant Mailed Critical | 07 Apr, 2020 | US10610489 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Apr, 2020 | US10610489 |
| Email Notification Critical | 19 Mar, 2020 | US10610489 |
| Issue Notification Mailed Critical | 18 Mar, 2020 | US10610489 |
| Dispatch to FDC | 05 Mar, 2020 | US10610489 |
| Application Is Considered Ready for Issue Critical | 05 Mar, 2020 | US10610489 |
| Issue Fee Payment Received Critical | 21 Feb, 2020 | US10610489 |
| Issue Fee Payment Verified Critical | 21 Feb, 2020 | US10610489 |
| Mail Notice of Allowance Critical | 07 Feb, 2020 | US10610489 |
FDA has granted several exclusivities to Synjardy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Synjardy, 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.
Exclusivity Information
Synjardy holds 6 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Synjardy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 26, 2018 |
| M(M-174) | Mar 18, 2019 |
| New Chemical Entity Exclusivity(NCE) | Aug 01, 2019 |
| New Indication(I-739) | Dec 02, 2019 |
| New Patient Population(NPP) | Jun 20, 2026 |
| Pediatric Exclusivity(PED) | Dec 20, 2026 |
Several oppositions have been filed on Synjardy'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's generic, the next section provides detailed information on ongoing and past EP oppositions related to Synjardy patents.
Synjardy's Oppositions Filed in EPO
Synjardy 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 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's family patents as well as insights into ongoing legal events on those patents.
Synjardy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Synjardy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 17, 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 Generic API suppliers:
Empagliflozin; Metformin Hydrochloride is the generic name for the brand Synjardy. 1 company has already filed for the generic of Synjardy. Check out the entire list of companies who have already received approval for Synjardy's generic
How can I launch a generic of Synjardy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Synjardy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Synjardy'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg | 01 Aug, 2018 | 4 | 07 Jul, 2022 | 03 Apr, 2034 | Eligible |
Alternative Brands for Synjardy
Synjardy which is used for treating type 2 diabetes mellitus with renal impairment and reducing cardiovascular risks., 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's active ingredient. Check the complete list of approved generic manufacturers for Synjardy
About Synjardy
Synjardy is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for treating type 2 diabetes mellitus with renal impairment and reducing cardiovascular risks. Synjardy uses Empagliflozin; Metformin Hydrochloride as an active ingredient. Synjardy was launched by Boehringer Ingelheim in 2015.
Approval Date:
Synjardy was approved by FDA for market use on 26 August, 2015.
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 is 26 August, 2015, its NCE-1 date is estimated to be 20 December, 2025.
Active Ingredient:
Synjardy uses Empagliflozin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Empagliflozin; Metformin Hydrochloride ingredient
Treatment:
Synjardy is used for treating type 2 diabetes mellitus with renal impairment and reducing cardiovascular risks.
Dosage:
Synjardy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;1GM | TABLET | Prescription | ORAL |
| 12.5MG;500MG | TABLET | Prescription | ORAL |
| 12.5MG;1GM | TABLET | Prescription | ORAL |
| 5MG;500MG | TABLET | Prescription | ORAL |