Synjardy Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Synjardy.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 27 Sep, 2023 US10610489
Recordation of Patent Grant Mailed 07 Apr, 2020 US10610489
Patent Issue Date Used in PTA Calculation 07 Apr, 2020 US10610489
Email Notification 19 Mar, 2020 US10610489
Issue Notification Mailed 18 Mar, 2020 US10610489
Dispatch to FDC 05 Mar, 2020 US10610489
Application Is Considered Ready for Issue 05 Mar, 2020 US10610489
Issue Fee Payment Received 21 Feb, 2020 US10610489
Issue Fee Payment Verified 21 Feb, 2020 US10610489
Mail Notice of Allowance 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

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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
Patent litigations
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

Synjardy has patent protection in a total of 45 countries. It's US patent count contributes only to 13.8% of its total global patent coverage. 2 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 Synjardy.

Family Patents

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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
Glyxambi Used for managing type 2 diabetes mellitus, including in patients with renal impairment, through the administration of drugs such as linagliptin and empagliflozin.
Jardiance Used for reducing cardiovascular risk and treating type 2 diabetes, heart failure, and chronic kidney disease with empagliflozin.
Synjardy Xr

(uses Empagliflozin; Metformin Hydrochloride)

Used for improving cardiovascular outcomes and managing type 2 diabetes, including in patients with renal impairment, by administering empagliflozin in combination with other medications.
Trijardy Xr used for treating Type 2 diabetes mellitus with insufficient glycemic control despite metformin therapy.

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