Details for Patent: 11,173,189

Which drugs does patent 11,173,189 protect, and when does it expire?

Patent 11,173,189 protects DAPZURA RT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 11,173,189

Title:	Daptomycin formulations containing a combination of sorbitol and mannitol
Abstract:	In an aspect, a method of manufacture of a pharmaceutically acceptable solid composition containing daptomycin includes drying an aqueous solution containing (i) water, (ii) the daptomycin, (iii) sorbitol in an amount of about 1.2 wt. % to about 9.0 wt. % of total volume of the aqueous composition and (iv) mannitol in an amount of about 0.6 wt. % to about 9.5 wt. % of total volume of the aqueous composition to form the solid composition. The drying can include an sublimation drying of about -25.degree. C. to about 50.degree. C. for a time period of about 15 hours to about 120 hours, most preferably about 15.degree. C. for about 20 hours, optionally preceded and/or followed by one or more additional drying steps. Other aspects are the solid composition containing the daptomycin and also methods of treating a bacterial infection including administering a pharmaceutically acceptable product made by reconstituting the solid composition.
Inventor(s):	Wegiel; Lindsay (Martinsville, IN), Miller; Reagan (Grayslake, IL)
Assignee:	Baxter International Inc. (Deerfield, IL) Baxter Healthcare SA (Glattpark, CH)
Application Number:	17/199,086
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Process;

United States Patent 11,173,189: A Detailed Analysis of Scope, Claims, and Patent Landscape

Overview of the Patent

The United States Patent 11,173,189, titled "Daptomycin formulations containing a combination of sorbitol and mannitol," is a significant development in the field of pharmaceuticals, particularly for the antibiotic daptomycin. This patent is held by Baxter Healthcare Corporation and is set to expire on March 11, 2041[2].

Scope of the Patent

The patent focuses on novel formulations of daptomycin, a cyclic lipopeptide antibiotic used to treat complicated skin and skin structure infections, as well as certain bloodstream infections caused by susceptible Gram-positive bacteria[4].

Key Components

The formulations described in this patent include a combination of daptomycin with sorbitol and mannitol. These excipients are crucial for enhancing the stability and reconstitution properties of the antibiotic.

• Sorbitol and Mannitol: These sugars act as stabilizers and bulking agents, improving the physical and chemical stability of the daptomycin formulation. They help in maintaining the integrity of the antibiotic during storage and reconstitution[1].

Claims of the Patent

The patent claims are comprehensive and cover various aspects of the formulation, including the method of manufacture, the composition itself, and the specific ratios of the components.

Method of Manufacture

The patent details a method of manufacturing a pharmaceutically acceptable solid composition of daptomycin. This involves drying an aqueous solution containing daptomycin, sorbitol, and mannitol. The drying step, particularly sublimation drying, is critical for removing ice from the composition without compromising the stability of the antibiotic[1].

Composition

The solid composition is defined by specific weight percentages of daptomycin, sorbitol, and mannitol. For example, the composition may include daptomycin as the active ingredient, with sorbitol and mannitol present in defined ratios to ensure optimal stability and reconstitution characteristics[1].

Patent Landscape

The patent landscape for daptomycin is complex, with multiple patents and generic versions in various stages of development.

Existing Patents

Several patents related to daptomycin formulations are currently active, including those held by Cubist Pharmaceuticals LLC, Xellia Pharmaceuticals Aps, and Hospira Inc. These patents cover different aspects such as high purity lipopeptides, methods for administration, and specific formulations[2].

Generic Versions

Generic versions of daptomycin are being developed by companies like Fresenius Kabi USA LLC, Hisun Pharmaceutical Hangzhou Co Ltd, and Hospira Inc. These generic versions are subject to the expiry dates of the existing patents, which can vary due to legal activities such as patent term extensions or amendments[2].

Legal and Regulatory Aspects

The legal status of patents, including US11173189B2, can be influenced by various factors such as patent term adjustments, legal challenges, and amendments to the patent claims.

Patent Expiry and Generic Launch

The expiry date of the patent (March 11, 2041) is crucial for the launch of generic versions. However, this date can be affected by legal activities such as patent term extensions or challenges to the patent claims[2].

Enablement and Written Description

The scope of patent claims, especially in the pharmaceutical industry, is subject to strict enablement and written description requirements under 35 U.S.C. § 112. This ensures that the patent claims are supported by sufficient disclosure to enable a person skilled in the art to make and use the invention[3].

Impact on Pharmaceutical Industry

The patent and its claims have significant implications for the pharmaceutical industry, particularly in the development and commercialization of daptomycin formulations.

Innovation and Competition

The patent protects the innovative formulation of daptomycin with sorbitol and mannitol, preventing competitors from using the same composition until the patent expires. This encourages further innovation in the field while allowing the patent holder to recoup their investment in research and development[3].

Patient Access

The availability of generic versions, once the patent expires, can improve patient access to the medication by reducing costs. However, the complexity of the patent landscape and ongoing legal activities can delay the entry of generics into the market[2].

Key Takeaways

• Novel Formulation: The patent introduces a novel formulation of daptomycin with sorbitol and mannitol, enhancing stability and reconstitution properties.
• Method of Manufacture: The patent details a specific method of manufacture involving sublimation drying.
• Patent Landscape: The patent is part of a complex landscape with multiple existing patents and generic versions in development.
• Legal and Regulatory: The patent is subject to strict enablement and written description requirements, and its expiry date can be influenced by legal activities.
• Industry Impact: The patent protects innovation and affects competition and patient access to the medication.

FAQs

What is the primary focus of United States Patent 11,173,189?

The primary focus of this patent is on novel formulations of daptomycin containing a combination of sorbitol and mannitol to enhance stability and reconstitution properties.

Who holds the United States Patent 11,173,189?

The patent is held by Baxter Healthcare Corporation.

What is the significance of sorbitol and mannitol in the patent?

Sorbitol and mannitol act as stabilizers and bulking agents, improving the physical and chemical stability of the daptomycin formulation.

How does the patent impact the pharmaceutical industry?

The patent protects innovation, affects competition, and influences patient access to the medication by delaying the entry of generic versions until the patent expires.

What are the key components of the method of manufacture described in the patent?

The method involves drying an aqueous solution containing daptomycin, sorbitol, and mannitol, with a focus on sublimation drying to remove ice without compromising the stability of the antibiotic.

Cited Sources

1. US11173189B2 - Daptomycin formulations containing a combination of sorbitol and mannitol - Google Patents
2. Drug Patents containing Daptomycin - Pharsight
3. Eviscerating Patent Scope - DigitalCommons@NYLS
4. Daptomycin: Uses, Interactions, Mechanism of Action - DrugBank
5. US9138456B2 - Lipopeptide compositions and related methods - Google Patents

Drugs Protected by US Patent 11,173,189

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Baxter Hlthcare Corp	DAPZURA RT	daptomycin	POWDER;INTRAVENOUS	213645-001	Jan 25, 2022		DISCN	Yes	No			Y			METHOD OF TREATING A BACTERIAL INFECTION BY ADMINISTERING A RECONSTITUTED SOLID FORMULATION OF DAPTOMYCIN CONTAINING 31.0 TO 59.4% WT TOTAL MANNITOL AND SORBITOL

International Family Members for US Patent 11,173,189

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021233893
Brazil	112022015170
Canada	3170514
China	115243675