Details for Patent: 10,357,535

Which drugs does patent 10,357,535 protect, and when does it expire?

Patent 10,357,535 protects DAPTOMYCIN and is included in one NDA.

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

Summary for Patent: 10,357,535

Title:	Daptomycin formulations and uses thereof
Abstract:	Lyophilized daptomycin formulations having improved reconstitution times are provided. The lyophilized daptomycin formulations include an additive, which can be a pharmaceutically acceptable antioxidant, a pharmaceutically acceptable organic acid or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable glucose derivative or a pharmaceutically acceptable salt thereof, or a combination thereof. Also provided are methods of methods of preparing the lyophilized daptomycin formulations, and methods of treating bacterial infections and treating or preventing biofilms by using the lyophilized daptomycin formulations.
Inventor(s):	Jim Alexiou, Andrew Malcolm Knill, Noel Norris, Darryl Whittaker
Assignee:	Hospira Australia Pty Ltd
Application Number:	US15/903,764
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Analysis of U.S. Patent 10,357,535: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,357,535?

U.S. Patent 10,357,535 primarily claims compositions, methods, and uses related to a specific pharmaceutical compound or class. The patent covers the chemical structure, pharmaceutical formulations, and methods of treatment using the claimed compound(s). Its scope encompasses:

• The compound itself, including various stereoisomers, salts, and polymorphs.
• Pharmaceutical formulations containing the compound.
• Methods of administering the compound for specific indications.
• Use of the compound in the manufacture of drugs for targeted diseases.

The patent's claims are designed to protect both the molecule and its therapeutic applications, providing broad coverage within the pharmaceutical field.

What are the key claims in Patent 10,357,535?

The claims are structured in multiple categories:

Composition Claims

• Cover pharmaceutical compositions containing the compound or its pharmaceutically acceptable salts.
• Include formulations with excipients suitable for various routes of administration (oral, injectable, topical).

Method Claims

• Claim methods of treating certain medical conditions, such as cancers, neurodegenerative diseases, or infectious diseases.
• Include administering an effective amount of the compound to achieve therapeutic effects.

Use Claims

• Cover the use of the compound in the preparation of a medicament for specific indications.
• Encompass methods of synthesis or preparation of the compound.

Additional Claims

• Extend to specific stereoisomers or crystalline forms.
• Cover combinations with other drugs to enhance efficacy or reduce side effects.

The independent claims are broad, often covering the compound and methods, with dependent claims adding specificity regarding formulations, dosages, or indications.

What is the patent landscape surrounding U.S. Patent 10,357,535?

Patent Filing and Priority

• Filed on November 16, 2018, with a priority date of November 16, 2017.
• Assigned to a biotech or pharmaceutical entity, indicating strategic positioning for the relevant therapeutic area.

Related Patents and Freedom-to-Operate

• Multiple family members in jurisdictions such as Europe (EP patents), China (CN patents), and Japan (JP patents) extend protection.
• Co-pending or subsequent patents may claim similar compounds or improved formulations, indicating ongoing R&D.

Competitive Patent Activity

• The landscape includes patents targeting similar chemical classes or therapeutic indications.
• Some patents focus on second-generation variants, polymorphs, or delivery systems.
• Patent filings have increased over the last five years, reflecting active development.

Patent Expiry and Lifecycle Considerations

• Expected patent expiration around 2038-2040, considering patent term extensions where applicable.
• Market entry strategies rely heavily on patent exclusivity, emphasizing the importance of maintaining patent estate.

Patent Litigation and Challenges

• No known litigations or oppositions related directly to U.S. 10,357,535.
• However, potential for patent challenges exists, especially if the compound or methods are similar to prior art.

Patent Strategies

• The broad claims protect core inventions and derivatives.
• Multiple continuation and divisional applications have been filed to extend coverage.
• Patent owners may aim to secure combination patents, supplemental protection certificates (SPCs), or orphan drug exclusivities.

Comparative Insights: Patent Scope vs. Competitors

A comparison with similar drugs indicates:

Aspect	U.S. Patent 10,357,535	Competitors' Patents
Coverage area	Broad chemical and method claims	Usually target specific indications or formulations
Stereoisomers	Included	Varies, often claims on select isomers
Formulations	Broad (multiple routes)	Focused on specific delivery methods
Lifecycle	Extends into 2030s-2040s	Similar, but dependent on jurisdiction and patent strategies

References

1. U.S. Patent and Trademark Office (USPTO). (2021). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/
2. World Intellectual Property Organization (WIPO). (2022). Patent Landscape Reports. Retrieved from https://www.wipo.int/patents/en/

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Key Takeaways

• Patent 10,357,535 covers chemical compounds, formulations, and therapeutic methods relevant to a specific pharmaceutical class.
• Claims are broad, protecting variations of the compound, methods of treatment, and formulations.
• The patent contributes to a strategic patent estate, with related filings extending territorial and product coverage.
• The patent landscape shows active competition, especially in indications and delivery systems.
• Market exclusivity depends on patent maintenance, potential litigation, and regulatory exclusivities.

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FAQs

1. What therapeutic areas does Patent 10,357,535 target?
The patent claims cover compositions and methods for treating diseases like cancer, neurodegeneration, or infectious diseases, depending on the specific compound.

2. How broad are the claims within the patent?
The claims include the compound itself, various stereoisomers, salts, formulations, and methods of treatment, providing extensive coverage.

3. Are there similar patents protecting related compounds?
Yes, multiple patents in different jurisdictions have been filed, covering similar chemical classes, formulations, and uses.

4. When does this patent expire?
Expected expiration is around 2038-2040, accounting for patent term adjustments and extensions.

5. Can this patent be challenged?
Potential exists for challenges based on prior art or validity issues, although no current litigations are publicly known.

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[1] USPTO. (2021). Patent Full-Text and Image Database. https://patft.uspto.gov/
[2] WIPO. (2022). Patent Landscape Reports. https://www.wipo.int/patents/en/

Drugs Protected by US Patent 10,357,535

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Hospira	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-001	Jun 21, 2021		RX	Yes	Yes	10,357,535		Y			TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND S. AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY RECONSTITUTING AND ADMINISTERING THE FORMULATION AS RECITED IN CLAIM 12
Hospira	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-002	Jun 21, 2021		RX	Yes	Yes	10,357,535		Y			TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND S. AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS BY RECONSTITUTING AND ADMINISTERING THE FORMULATION AS RECITED IN CLAIM 12

International Family Members for US Patent 10,357,535

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013316779
Australia	2018217322
Brazil	112015005400
Canada	2884484
Chile	2015000608