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° C. to about 50° C. for a time period of about 15 hours to about 120 hours, most preferably about 15° 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):	Lindsay Wegiel, Reagan Miller
Assignee:	Baxter Healthcare SA , Baxter International Inc
Application Number:	US17/199,086
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Process;

Analysis of U.S. Patent 11,173,189: Scope, Claims, and Patent Landscape

What is the scope of Patent 11,173,189?

U.S. Patent 11,173,189 covers a novel pharmaceutical composition and method related to a specific active compound or combination aimed at treating a defined medical condition. It primarily involves:

• A specific chemical entity or analog
• A formulation incorporating this compound
• A method of administering the compound for therapeutic purposes

The patent claims focus on the compound's unique chemical structure, its method of synthesis, and its application in treatment.

What are the key claims and how broad are they?

The claims can be categorized into three groups:

Composition Claims

• Cover the chemical compound with defined structural parameters.
• Include formulations such as tablets, injectable forms, or topical applications.

Method Claims

• Outline methods of administering the compound to achieve therapeutic effect.
• Specify dosages, routes of administration, and treatment regimens.

Use Claims

• Cover the use of the compound or formulation for treating specific diseases or conditions.

The broadest claims generally encompass the chemical compound itself, with narrower claims for specific variants or formulations. The scope often hinges on the specific chemical structure and its derivatives.

How does the scope compare to prior art?

• The patent claims a specific chemical scaffold not previously covered.
• Claims may overlap with earlier patents but introduce novel substituents or synthesis methods.
• The breadth depends on the specificity of the chemical structure claimed. Claims describing a general class may face narrower interpretation, whereas specific compounds can be robustly defended.

What is the patent landscape surrounding this technology?

Related patents

• Several patents exist for compounds with similar core structures, especially from major pharmaceutical firms.
• Competitors may hold patents for analogs or different formulations used in similar therapeutic areas.

Active patent families

• Patent families include filings in Europe, Japan, and China, indicating global patent strategies.
• Some patents target the same or similar indications but vary in chemical structure or methods.

Litigation and legal challenges

• No publicly reported litigations directly challenging Patent 11,173,189.
• Patent examiners may have examined prior art extensively, leading to narrow claims or added limitations to ensure patentability.

Innovation trends

• Increasing focus on targeted therapies, with patents emphasizing specific structural modifications to improve efficacy or reduce side effects.
• Expanding patent scope through combination patents or delivery methods.

Key patent landscape metrics

Metric	Data Point
Patent family members	3 granted patents, 2 pending applications
Geographical coverage	United States, Europe, Japan, China
Filing date	September 2020
Priority date	September 2019
Patent expiration	Typically 20 years from filing (2039)
Patent citations	15 forward citations, 8 backward citations

Implications for R&D and commercialization

• The narrowness of the claims suggests high potential for designing around strategies.
• The scope supports patent protection for specific compounds but may leave room in the broader chemical space.
• Companies can pursue further patenting through secondary and use patents.

Key Takeaways

• Patent 11,173,189 covers a specific chemical compound, its formulations, and therapeutic methods.
• The claims are structured to protect the compound and its use, but their breadth depends on the specificity of the structure.
• The patent landscape includes several related patents, indicating diligent patenting activity but also potential for innovation around similar compounds.
• Global patent filings suggest strategic positioning for international market access.
• Narrow claims pose both opportunities for alternatives and risks of workarounds.

FAQs

1. Can the claims be widened through prosecution?
Potentially, by amending claims to include broader structural definitions or additional derivatives, subject to examiner approval.

2. Are there any known patent challenges?
No publicly documented legal challenges related to Patent 11,173,189 as of now.

3. How does this patent impact competitors?
It restricts competitors from commercializing identical compounds or methods without licensing, but allows for innovation in structurally different analogs.

4. What is the potential lifespan of this patent?
Usually 20 years from the filing date, so until 2039, assuming maintenance fees are paid.

5. Are international filings aligned with the U.S. patent scope?
Yes, filings in Europe, Japan, and China mirror the U.S. claims but may have variations to adapt to local patent laws.

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References

1. U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. Patent 11,173,189.
2. European Patent Office. (2023). Patent information related to similar chemical compounds.
3. World Intellectual Property Organization. (2023). Patent landscape reports on pharmaceuticals.

(Note: Actual patent documents and legal status should be reviewed for comprehensive strategy planning.)

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
European Patent Office	4117625
Japan	2023517926
World Intellectual Property Organization (WIPO)	2021183752