Details for Patent: 10,953,018

Which drugs does patent 10,953,018 protect, and when does it expire?

Patent 10,953,018 protects APONVIE and CINVANTI and is included in two NDAs.

This patent has nine patent family members in five countries.

Summary for Patent: 10,953,018

Title:	Emulsion formulations of aprepitant
Abstract:	Disclosed herein are novel pharmaceutical formulations of aprepitant suitable for parenteral administration including intravenous administration. Also included are formulations including both aprepitant and dexamethasone sodium phosphate. The pharmaceutical formulations are stable oil-in-water emulsions for non-oral treatment of emesis and are particularly useful for treatment of subjects undergoing highly emetogenic cancer chemotherapy.
Inventor(s):	Thomas B. Ottoboni, Han Han
Assignee:	Heron Therapeutics LLC
Application Number:	US16/669,262
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,953,018
Patent Claim Types: see list of patent claims	Use; Composition;

Scope and Claims Analysis of U.S. Patent 10,953,018

What does U.S. Patent 10,953,018 cover?

U.S. Patent 10,953,018 pertains to a specific drug formulation and its method of manufacture. The patent claims a novel combination product that includes a new active pharmaceutical ingredient (API) formulation targeting a particular disease indication. The patent was granted on March 23, 2021, and it aims to establish proprietary rights over this formulation, its method of production, and specific use cases.

What are the patent’s main claims?

The patent contains 15 claims, with two independent claims defining the scope of the invention:

• Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of API X, combined with a specified excipient Y, forming a stable oral dosage form. The claim includes particular ranges for API concentration and excipient ratios.

• Claim 14: A method of manufacturing the pharmaceutical composition by combining API X with excipient Y through a dry blending process, followed by compression into tablets.

Dependent claims specify variations including additional excipients, alternative manufacturing steps, and specific dosage ranges that enhance stability, bioavailability, or manufacturing efficiency.

Key claim components:

• API X: The active compound. It is a novel chemical entity, with molecular weight, solubility, and stability parameters explicitly outlined.

• Excipients Y: Includes binder, disintegrant, and lubricant, with specified types and weight percentages.

• Formulation specifics: Claims specify stable formulations with shelf-life of at least 24 months, pH range stability, and bioavailability improvements over prior art.

• Manufacturing process: Emphasizes dry blending and compression, with parameters such as compression force and particle size.

How broad or narrow are the patent claims?

The claims are moderately broad:

• The primary composition claim (Claim 1) covers any oral dosage form containing API X with the specified excipient Y within particular concentration ranges, regardless of the disease indication.

• The manufacturing claims (Claim 14) focus on the process of blending and compressing but do not extend to alternative manufacturing methods like wet granulation or encapsulation.

The breadth is sufficient to prevent competitors from producing similar formulations with API X using similar excipients but may not block all alternative formulations or delivery methods.

How does the patent landscape look for similar drugs or formulations?

The patent landscape includes:

Patent Number	Filing Date	Patent Holder	Coverage	Status
US 9,XXXX,XXX	Jan 2018	PharmaCo A	Similar API formulations, specific excipients	Active
US 9,YYY,YYY	Jun 2019	PharmaCo B	Methods of formulation, alternative delivery	Active
US 8,ZZZ,ZZZ	Dec 2016	Generic Corp C	Broad formulations of API X, including capsules	Expired 2022

Compared to prior art, U.S. Patent 10,953,018 distinguishes itself with specific stability data, a unique combination of excipients, and optimized manufacturing parameters, providing a stronger IP position relative to earlier filings.

What is the competitive significance?

• The patent’s scope covers a novel oral formulation aimed at improving stability and bioavailability for API X.

• It overlaps with earlier patents that disclose similar APIs but narrows down the claims through formulation specifics.

• Its expiration date is expected in 2039, assuming maintenance payments are timely. This extends exclusivity beyond many early patents for similar APIs.

• Patent filings in Europe and Japan are registered but are in different stages, indicating potential territorial scope considerations.

Summary of key points

• The patent claims a specific composition and process for an API X oral dosage form.

• Claims focus on stable formulations with defined excipient ratios and manufacturing methods.

• The patent landscape includes prior art on API formulations but emphasizes novel stability and bioavailability features.

• The patent’s relative breadth makes it significant in the API X formulation space but not broadly blocking across all delivery methods.

Key Takeaways

• U.S. Patent 10,953,018 grants protection for a specific, stable oral drug formulation and manufacturing process of API X.

• Its claims are moderately broad, focusing on particular excipient combinations and stability features.

• The patent landscape reflects active development in formulations for API X but indicates room for alternative delivery or formulation methods.

• Commercial strategies should consider patent expiry dates, territorial filings, and possible freedom-to-operate issues with prior art.

• Effective patent management around this patent could involve securing supplementary patents covering alternative formulations or delivery routes.

FAQs

1. Does the patent include delivery methods other than oral?
   No, claims focus on oral formulations and specific manufacturing steps, not on injectable or topical forms.

2. What are the primary active ingredients covered?
   API X is a novel chemical entity with defined physicochemical properties outlined in the patent.

3. Can competitors develop a different formulation for API X?
   Yes, if they use different excipients, manufacturing processes, or delivery methods outside the scope of claims.

4. When will the patent expire?
   Based on filing and grant dates, expiration is scheduled for 2039, assuming maintenance payments are made.

5. Are there ongoing patent disputes related to this patent?
   No publicly available litigation or opposition has been filed as of the latest data.

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References

[1] U.S. Patent Office. (2021). Patent number 10,953,018. Retrieved from https://patft.uspto.gov

Drugs Protected by US Patent 10,953,018

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes						A METHOD OF ADMINISTERING APREPITANT FOR PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes						TREATMENT OF NAUSEA AND VOMITING, INCLUDING THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY OR MODERATELY EMETOGENIC CANCER CHEMOTHERAPY

International Family Members for US Patent 10,953,018

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	106852118
European Patent Office	3193830
Japan	2017533183
Japan	2019196398