Details for Patent: 10,022,379

Which drugs does patent 10,022,379 protect, and when does it expire?

Patent 10,022,379 protects TRIJARDY XR, JENTADUETO XR, and JENTADUETO, and is included in three NDAs.

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

This patent has forty-eight patent family members in twenty-eight countries.

Summary for Patent: 10,022,379

Title:	DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Abstract:	The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Inventor(s):	Friedl; Thomas (Ochsenhausen, DE), Braun; Michael (Senden, DE), Egusa; Kenji (Biberach an der Riss, DE), Fujita; Hikaru (Osaka, JP), Maruyama; Megumi (Hyogo, JP), Nishioka; Takaaki (Kobe, JP)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	15/403,705
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,022,379
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 10,022,379

Introduction

United States Patent 10,022,379, titled "DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation," is a significant patent in the pharmaceutical industry, particularly in the treatment of diabetes. This patent is owned by Boehringer Ingelheim International GmbH and plays a crucial role in the protection of their drug Jentadueto.

Patent Overview

Inventors and Assignees

The patent was invented by a team of researchers including Friedl Thomas, Braun Michael, Egusa Kenji, Fujita Hikaru, Maruyama Megumi, and Nishioka Takaaki. It is assigned to Boehringer Ingelheim International GmbH, a major pharmaceutical company[5].

Issuance and Expiration Dates

The patent was issued on July 17, 2018, and is set to expire on April 2, 2029[5].

Scope of the Patent

Pharmaceutical Compositions

The patent covers pharmaceutical compositions that combine a DPP-4 inhibitor (such as linagliptin) with another antidiabetic agent (such as metformin). These compositions are designed to treat diabetes and other related metabolic disorders. The patent specifies the formulation, preparation, and use of these fixed-dose combinations[4][5].

Claims

The patent includes several claims that define the scope of protection:

• Active Ingredients: The patent claims the combination of a DPP-4 inhibitor and another antidiabetic agent.
• Formulations: It covers various tablet formulations of these combinations.
• Preparation Processes: The patent details the processes for preparing these pharmaceutical compositions.
• Therapeutic Uses: It specifies the use of these compositions for treating diabetes and related conditions[4].

Patent Claims and Scope

Independent Claims

The patent includes independent claims that define the core inventions. These claims are crucial as they set the boundaries of what is protected under the patent. For example, Claim 1 might describe the specific combination of linagliptin and metformin in a tablet form, while subsequent claims might detail the dosage, preparation methods, and therapeutic applications[4].

Dependent Claims

Dependent claims build upon the independent claims, providing additional details and narrowing the scope. These claims might include specific dosage strengths, additional ingredients, or particular manufacturing processes[4].

Patent Landscape and Competitors

Patent Protection Period

The patent is part of a broader portfolio of patents protecting Jentadueto, which includes multiple patents with varying expiration dates. This ensures that the drug remains protected until at least December 4, 2030, when the last of the key patents is set to expire[1][2].

Litigations and Challenges

The patent has been subject to legal challenges. For instance, Mylan Pharmaceuticals Inc. has filed paragraph IV certifications challenging the validity of several patents, including this one. However, these challenges have been addressed through litigation, with some patents being declared invalid while others remain in force[2].

Impact on Generic Launch

Generic Availability

The expiration of this patent, along with other related patents, will pave the way for generic versions of Jentadueto. However, the estimated generic launch date is December 4, 2030, due to the complex patent landscape and ongoing litigations[1][2].

Competitive Landscape

The protection offered by this patent and others in the portfolio ensures that Boehringer Ingelheim maintains market exclusivity for Jentadueto until the patents expire. This exclusivity is crucial for the company's revenue and market position in the diabetes treatment market[1][2].

Technical and Therapeutic Significance

DPP-4 Inhibitors and Antidiabetic Agents

The combination of a DPP-4 inhibitor with another antidiabetic agent, as described in the patent, offers a significant therapeutic advantage in managing diabetes. This combination helps in achieving better glycemic control with fewer side effects compared to monotherapy[4].

Clinical Implications

The patent's focus on fixed-dose combinations enhances patient compliance and simplifies treatment regimens. This is particularly important for chronic conditions like diabetes, where adherence to medication is critical for effective management[4].

Conclusion

United States Patent 10,022,379 is a pivotal patent in the pharmaceutical industry, particularly in the treatment of diabetes. It protects the combination of a DPP-4 inhibitor and another antidiabetic agent, ensuring Boehringer Ingelheim's market exclusivity for Jentadueto until the patent expires. The patent's scope, claims, and the broader patent landscape are crucial for understanding its impact on the pharmaceutical market and the potential for generic competition.

Key Takeaways

• Patent Ownership: Owned by Boehringer Ingelheim International GmbH.
• Issuance and Expiration: Issued on July 17, 2018, and set to expire on April 2, 2029.
• Scope: Covers pharmaceutical compositions combining a DPP-4 inhibitor with another antidiabetic agent.
• Claims: Includes independent and dependent claims defining the core inventions and their applications.
• Patent Landscape: Part of a broader portfolio protecting Jentadueto until December 4, 2030.
• Litigations: Subject to legal challenges, with some patents declared invalid.
• Generic Launch: Estimated generic launch date is December 4, 2030.
• Therapeutic Significance: Enhances glycemic control and patient compliance.

Frequently Asked Questions (FAQs)

What is the main subject of United States Patent 10,022,379?

The main subject of this patent is the combination of a DPP-4 inhibitor (such as linagliptin) with another antidiabetic agent (such as metformin) in pharmaceutical compositions, including their preparation and therapeutic use.

Who owns this patent?

This patent is owned by Boehringer Ingelheim International GmbH.

When is the patent set to expire?

The patent is set to expire on April 2, 2029.

What are the implications of this patent for generic drug manufacturers?

The expiration of this patent, along with other related patents, will allow generic manufacturers to produce and market generic versions of Jentadueto, estimated to be around December 4, 2030.

Have there been any legal challenges to this patent?

Yes, there have been legal challenges, including paragraph IV certifications filed by Mylan Pharmaceuticals Inc., which have resulted in some patents being declared invalid.

Sources Cited

1. Pharsight: Jentadueto patent expiration.
2. FDA: ANDA 208430 tentative approval.
3. Hoover Institution: Patent Claims and Patent Scope.
4. Google Patents: DPP-IV inhibitor combined with a further antidiabetic agent.
5. Drugs.com: Generic Jentadueto XR Availability.

Drugs Protected by US Patent 10,022,379

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	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-001	Jan 27, 2020		RX	Yes	No	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-002	Jan 27, 2020		RX	Yes	No	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-003	Jan 27, 2020		RX	Yes	No	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	TRIJARDY XR	empagliflozin; linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212614-004	Jan 27, 2020		RX	Yes	Yes	10,022,379		Y			METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	10,022,379*PED				Y

International Family Members for US Patent 10,022,379

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	071175
Australia	2009232043
Brazil	PI0911273
Canada	2720450
Chile	2009000809