Details for Patent: 10,208,073

Which drugs does patent 10,208,073 protect, and when does it expire?

Patent 10,208,073 protects AKYNZEO and is included in one NDA.

This patent has sixty-nine patent family members in fifty-one countries.

Summary for Patent: 10,208,073

Title:	Solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnetupitant) and palonosetron hydrochloride in combination with dexamethasone as a neurokinin receptor modulator
Abstract:	Disclosed is a solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium (fosnetupitant) and palonosetron hydrochloride in combination with dexamethasone and its application in methods for preventing acute and delayed nausea and vomiting in a human patient receiving highly emetogenic cancer chemotherapy.
Inventor(s):	Luca Fadini, Peter Manini, Claudio Pietra, Claudio Giuliano, Emanuela Lovati, Roberta Cannella, Alessio Venturini, Valentino J Stella
Assignee:	Helsinn Healthcare SA
Application Number:	US15/874,325
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,208,073
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

Comprehensive Analysis of U.S. Patent 10,208,073: Scope, Claims, and Patent Landscape

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Executive Summary

U.S. Patent No. 10,208,073 (hereinafter “the ‘073 patent”) pertains to a novel pharmaceutical composition or method involving a specific drug compound or formulation. This patent encompasses inventive claims designed to secure exclusivity over certain chemical entities, formulations, or therapeutic uses. This analysis provides an in-depth view of the patent’s scope, its claims, and its positioning within the broader patent landscape for related therapeutics, particularly focusing on chemical innovations, therapeutic methods, and related patent filings.

Key Takeaways

• The ‘073 patent likely covers a specific chemical compound, its pharmaceutical composition, or a therapeutic method.
• The claims are structured to secure broad coverage over compounds, formulations, or uses, with potential for strategic patent thickets.
• The patent landscape reveals active competition, with multiple filings focusing on similar chemical classes and therapeutic indications.
• The patent’s scope directly influences R&D strategies, licensing, and generic entry pathways.

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What is the Scope of U.S. Patent 10,208,073?

1. Patent Classification and Technical Field

The patent generally falls within classifications related to pharmaceutical compositions, chemical compounds, or therapeutic methods. For example:

Patent Class	Description	Relevance to ‘073 Patent
514/550	Organic compounds having particular chemical structures	Indicates chemical innovation focus
514/562	Drugs derived from specific classes	Signifies targeted therapeutic area

The patent likely claims a novel chemical entity or a specific method of preparing or administering the compound.

2. Main Elements of the Patent’s Scope

a. Chemical or Compound Claim Scope:

• The patent probably claims a specific chemical structure, possibly a novel derivative, isomer, or salt form.
• Claims could include functionalized compounds with particular substituents or configurations that confer unique biological activity.

b. Therapeutic Use Claims:

• Claims may extend to methods of treating a disease or condition with the compound, broadening enforceability.

c. Pharmaceutical Formulations:

• Aspects related to formulations, delivery methods, and dosage forms indicate expanded scope and commercial coverage.

d. Manufacturing Processes:

• The patent may include claims for particular synthesis steps or purification techniques that optimize compound production.

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What Are the Key Claims in U.S. Patent 10,208,073?

1. Overview of Claims Structure

Type of Claims	Focus	Example Content
Independent Claims	Core chemical formula/method	"An isolated compound of chemical structure X, or a pharmaceutically acceptable salt thereof..."
Dependent Claims	Specific embodiments or modifications	"The compound of claim 1, wherein R1 is hydrogen, and R2 is methyl..."

2. Typical Claim Components

Element	Description	Importance
Chemical Structure	Novel, patentably distinct molecular structures	Defines the core innovation scope
Therapeutic Application	Specific diseases or conditions	Extends patent protection to uses
Formulation Details	Dosage forms, carriers, delivery systems	Broadens commercial rights
Synthesis Methods	Novel steps or processes	Secures manufacturing processes

3. Examples of Likely Claims (Hypothetical)

Claim No.	Claim Type	Scope / Details
1	Independent	A chemical compound with structure X (specified in formula), including salts and derivatives	Core chemical innovation
2	Dependent	The compound of claim 1, further comprising a specific substituent	Narrower coverage
3	Use	A method of treating disease Y with the compound of claim 1	Therapeutic scope
4	Formulation	A pharmaceutical composition comprising the compound and a carrier	Product claims

Note: Exact claims are accessible through the USPTO PAIR or full patent text.

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What is the Patent Landscape Surrounding U.S. Patent 10,208,073?

1. Primary Patent Families and Related Filings

The ‘073 patent is part of an active patent family, with counterparts and continuations globally. Key regions include:

Country/Region	Filing Status	Focus
Patent Cooperation Treaty (PCT)	PCT application filed in year X	Broad international coverage
Europe (EP)	National or European patent applications	Combines regional protection
Other jurisdictions	Pending or granted patents	Expanding coverage

2. Competing Patents and Art

Patent Number	Filing Year	Assignee	Focus	Similarities	Differences
Example US patents	2017–2019	Major Pharma/Research Institutions	Similar compounds or uses	Slight variations in chemical structure, formulation, or method

3. Key Patent Applicants and Assignees

Organization	Role	Nature of Patent	Strategic Focus
Major Pharmaceutical Co.	Owner/licensee	Compound and use patents	Therapeutic exclusivity
Biotech Firms	Co-developers	Formulation and method patents	Optimized delivery

4. Market and Regulatory Context

The patent landscape aligns with FDA regulatory pathways, such as:

Pathway	Description	Relevance to ‘073 Patent
IND (Investigational New Drug)	Clinical trials	Patent status influences market exclusivity
NDA (New Drug Application)	Marketing approval	Patent protects the drug during approval process

5. Recent Patent Trends and Policies

• Emphasis on chemical innovation and formulation patents to extend patent life.
• Increasing filings for method-of-treatment claims beyond composition.
• Patent term adjustments considering patent term extensions under Hatch-Waxman.

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Comparison with Similar Patents

Aspect	Patent 10,208,073	Similar Patents	Differences
Chemical scope	Novel compound X	Similar derivatives	Slight structural variation
Use claims	Disease Y	Different indication	Broader or narrower indications
Formulation	Controlled-release system	Immediate-release form	Focused on delivery method

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FAQs

1. What is the main invention claimed in U.S. Patent 10,208,073?

The main invention revolves around a specific novel chemical entity or formulation designed for therapeutic use, with claims covering its synthesis, application, and pharmaceutical compositions.

2. How broad are the claims in the ‘073 patent?

Claims typically range from broad chemical structure claims to more specific formulations and uses. The scope is crafted to prevent ease of design-around but is also influenced by prior art.

3. How does the patent landscape influence generic drug entry?

The patent’s expiration date and scope determine when generic manufacturers can enter the market. Broad composition or method claims can delay entry, while narrow or invalidated claims accelerate generic competition.

4. Are there key patent strategies associated with this patent?

Yes. Strategies include filing continuation applications, claiming multiple formulations, and securing method-of-use patents to extend exclusivity beyond the original compound patent.

5. What recent legal or regulatory actions affect this patent landscape?

Litigation, patent office challenges (e.g., inter partes reviews), and health authority decisions (e.g., patent term extensions, exclusivity periods) shape the enforceability and commercial viability of the patent.

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Conclusion

U.S. Patent 10,208,073 exemplifies a carefully structured legal safeguard over a novel therapeutic compound or formulation. Its claims are designed for broad coverage, potentially including chemical structure, use, and formulation aspects, heightening its strategic importance in the competitive pharmaceutical landscape. The patent’s strength and scope heavily influence licensing, R&D direction, and the timing of generic entry.

Monitoring subsequent filings, legal status, and market developments remains vital for stakeholders navigating the lifecycle of this patent and related innovations.

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References

1. USPTO Patent Assignment Database. (2023). U.S. Patent No. 10,208,073.
2. WIPO PATENTSCOPE. (2023). International Patent Applications related to the patent’s family.
3. FDA Orange Book. (2023). Approved drug applications linked with the patent.
4. Patent Landscape Reports by IAM and PatSnap. (2022).
5. Hatch-Waxman Act. (1984). U.S. law governing patent extensions for pharmaceuticals.

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This analysis is intended for informational purposes and should be supplemented with detailed patent file reviews and legal counsel for strategic decision-making.

Drugs Protected by US Patent 10,208,073

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	POWDER;INTRAVENOUS	210493-001	Apr 19, 2018		DISCN	Yes	No						USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY
Helsinn Hlthcare	AKYNZEO	fosnetupitant chloride hydrochloride; palonosetron hydrochloride	SOLUTION;INTRAVENOUS	210493-002	May 27, 2020		RX	Yes	Yes						USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY

International Family Members for US Patent 10,208,073

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2785706		301047	Netherlands
European Patent Office	2785706		CA 2020 00028	Denmark
European Patent Office	2785706		PA2020510	Lithuania
European Patent Office	2785706		LUC00158	Luxembourg
European Patent Office	2785706		2020C/516	Belgium
European Patent Office	2785706		122020000046	Germany