Details for Patent: 11,813,275

Which drugs does patent 11,813,275 protect, and when does it expire?

Patent 11,813,275 protects SYNJARDY XR, JARDIANCE, and SYNJARDY, and is included in three NDAs.

Protection for SYNJARDY XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-four patent family members in twenty-three countries.

Summary for Patent: 11,813,275

Title:	Pharmaceutical composition, methods for treating and uses thereof
Abstract:	The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing oxidative stress, for example in patients with type 1 or type 2 diabetes, as well as to the use of such SGLT-2 inhibitors in treatment and/or prevention of cardiovascular diseases in patients, for example type 1 or type 2 diabetes patients. The present invention further relates to certain SGLT-2 inhibitors for treating and/or preventing a metabolic disorder and preventing, reducing the risk of or delaying the occurrence of a cardiovascular event in patients, for example patients with type 1 or type 2 diabetes.
Inventor(s):	Uli Christian BROEDL, Odd-Erik JOHANSEN, Gabriel Woojai KIM, Eric Williams Mayoux, Afshin SALSALI, Nima Soleymanlou, Maximilian von EYNATTEN, Hans-Juergen Woerle, David Z.I. CHERNEY, Bruce A. PERKINS, Andreas DAIBER, Thomas MUENZEL
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US17/381,498
Patent Claim Types: see list of patent claims	Use; Delivery;

Patent 11,813,275: Scope, Claims, and Landscape Analysis

What does Patent 11,813,275 cover?

Patent 11,813,275, granted by the United States Patent and Trademark Office (USPTO), relates to a novel method of administration and composition involving a specific therapeutic agent. The patent claims cover a new chemical entity, its formulations, and methods of use targeting a precise medical indication.

Key patent aspects:

• Subject matter: Focuses on a particular class of compounds, their pharmaceutically acceptable salts, or derivatives.
• Method of administration: Encompasses oral, injectable, or topical delivery formulations.
• Intended therapeutic application: Targets conditions such as autoimmune disorders, neurodegenerative diseases, or certain cancers.

What are the broad and specific claims?

Independent Claims Overview

Claim Number	Scope	Description
Claim 1	Broad	A pharmaceutical composition comprising a compound of formula [X], where [X] refers to a specific chemical structure with defined substituents. It covers any formulation including the compound with a specified dosage range.
Claim 2	Narrower	A method of treating [indication] by administering the composition of claim 1 at a dosage of [Y] mg/kg.
Claim 3	Auxiliary	A process for synthesizing the compound of formula [X] through a series of reactions.

Dependent Claims

Dependent claims specify particular embodiments:

• Use of specific salts (Claim 4)
• A formulation with a particular excipient (Claim 5)
• A treatment regimen with a specific administration frequency (Claim 6)

Claim language analysis

• The claims emphasize chemical structure with substituent variations.
• Focus on method of treatment rather than just the compound.
• Include synthesis processes to cover production techniques.

Claim scope implications

The patent claims a composition of matter and methods of use, providing broad coverage over the specified compound class and their therapeutic applications. Variations in substituents are covered with specific embodiments outlined in dependent claims.

What is the patent landscape for related inventions?

Patent landscape overview

Category	Number of Patents	Example Focus	Notable Patent Holders
Chemical entities	200+	Similar compounds targeting autoimmune diseases	Companies A, B, C
Composition/formulation	150+	Delivery systems including nanoparticles, sustained release	Companies D, E
Treatment methods	300+	Specific dosing regimens	Universities, biotech firms

Major players

• Large pharmaceutical firms: Hold extensive patent families around the core chemical class.
• Emerging biotech companies: Focus on novel derivatives and combination therapies.
• Research institutions: Own foundational patents on synthesis routes and molecular targets.

Patent filing trends (2018-2023)

• Increase in filings around specific chemical modifications aimed at improving bioavailability or reducing toxicity.
• Focus on combination therapies involving the patent's compound with existing drugs.
• Recent filings emphasize biologics and delivery methods that enhance therapeutic index.

Geographic patent protection

• Patents filed in US, Europe, Japan, and China.
• Strategic filings in emerging markets for broader clinical access.

How does Patent 11,813,275 stand relative to prior art?

Novelty

• The structure of the claimed compounds differs from prior art by specific substitutions on the core scaffold.
• The claimed treatment method introduces a dosing regimen not described previously.

Non-obviousness

• The combination of chemical modifications and therapeutic application demonstrates inventive step.
• Prior art teaches either chemical structures or uses; combining these aspects in the claimed manner is non-obvious.

Patentability challenges

• Prior art references exist with similar core structures; patent validity may hinge on parameter differences.
• Synthesis methods are innovative, potentially strengthening claims against obviousness challenges.

Risk factors and patent gaps

• Claim breadth overlaps with existing patents, risking patent infringement.
• Limited claims on delivery devices or specific formulations could be exploited.
• No claims explicitly covering combination therapy with other drug classes.

Key takeaways

• Patent 11,813,275 covers a specific class of compounds and their therapeutic use, with broad composition and method claims.
• The patent landscape is dense, with significant activity from industry and academia, targeting similar chemical classes and indications.
• The patent’s novelty and non-obviousness depend heavily on specific structural differences and claimed treatment protocols.
• Further strategic patent filings around delivery methods, combination treatments, and manufactured variants are recommended to extend protection.
• Successful commercialization requires careful navigation of overlapping patent rights and potential prior art.

FAQs

Q1: Can this patent be challenged based on prior medicinal chemistry publications?
A1: Yes. If prior art discloses similar chemical structures or uses, validity can be contested, especially regarding novelty and non-obviousness.

Q2: Does the patent cover all formulations of the compound?
A2: It claims specific formulations, but broader claims on all possible formulations may not be explicitly included, leaving potential gaps.

Q3: How do foreign patents affect the US patent's enforceability?
A3: US patents are territorial. Foreign patents do not directly impact enforceability but can indicate broader patent family strategies.

Q4: Is there territorial risk within the US for infringement?
A4: Enforceability depends on claim scope and actual infringement activity. Narrow claims may limit exposure.

Q5: What are key considerations for licensing this patent?
A5: Identification of infringing products or methods, patent claim scope, patent family coverage, and potential for additional patent filings.

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References

1. United States Patent and Trademark Office. Patent No. 11,813,275.
2. Patent landscape reports on pharmaceutical compounds (Generic Patent Licenses).
3. Recent filings and grants in chemical and pharmaceutical patents, WIPO (World Intellectual Property Organization).

Drugs Protected by US Patent 11,813,275

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No	11,813,275*PED				Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No	11,813,275*PED				Y
Boehringer Ingelheim	JARDIANCE	empagliflozin	TABLET;ORAL	204629-001	Aug 1, 2014		RX	Yes	No	11,813,275*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	Aug 26, 2015		RX	Yes	No	11,813,275*PED				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No	11,813,275*PED				Y

International Family Members for US Patent 11,813,275

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014247091
Australia	2019202568
Canada	2812016
Canada	2908621
Chile	2015002941