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Last Updated: February 12, 2025

Details for Patent: 10,208,073


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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-to- lyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnet- upitant) 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-to- lyl)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): Fadini; Luca (Giubiasco, CH), Manini; Peter (Giubiasco, CH), Pietra; Claudio (Como, IT), Giuliano; Claudio (Como, IT), Lovati; Emanuela (Mendrisio, CH), Cannella; Roberta (Varese, IT), Venturini; Alessio (Varese, IT), Stella; Valentino J (Lawrence, KS)
Assignee: Helsinn Healthcare SA (Lugano/Pazzallo, CH)
Application Number:15/874,325
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;
Patent landscape, scope, and claims:

United States Patent 10,208,073: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 10,208,073, titled "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," is a critical patent in the pharmaceutical industry, particularly for the drug Akynzeo. This patent is owned by Helsinn Healthcare Sa and is part of a broader patent portfolio protecting Akynzeo.

Patent Overview

Patent Title and Description

The patent describes a specific solution that combines fosnetupitant, a selective NK1 receptor antagonist, with palonosetron hydrochloride and dexamethasone. This combination is used as a neurokinin receptor modulator, primarily for the prevention of chemotherapy-induced nausea and vomiting (CINV)[4].

Patent Number and Status

The patent number is US 10,208,073 B2, and it is currently active. The legal status indicates that it is not expired and remains in force[4].

Claims and Scope

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims are crucial as they specify what is protected under the patent. For example, Claim 1 describes the specific solution composition, including the chloride hydrochloride salt of fosnetupitant, palonosetron hydrochloride, and dexamethasone, highlighting the unique combination and its application as a neurokinin receptor modulator[4].

Dependent Claims

Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These claims often specify particular aspects of the composition, such as the ratio of the active ingredients, the method of administration, or specific formulations.

Metrics for Measuring Patent Scope

Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process[3].

Patent Landscape

Related Patents

The patent 10,208,073 is part of a larger portfolio of patents protecting Akynzeo. Other related patents include US9403772, US10717721, and US11312698, which cover various aspects of the drug, such as stability improvements and crystalline forms of the active ingredients[1].

Exclusivities and Market Protection

In addition to the patent protection, Akynzeo has been granted several exclusivities by the FDA. These exclusivities prevent other companies from marketing generic or bioequivalent versions of Akynzeo, even if the patents have expired or are set to expire soon. This significantly delays the entry of generic competitors into the market[1].

Litigation and Settlements

Patent Infringement Cases

Patents related to Akynzeo, including those in the same family as US 10,208,073, have been involved in various patent infringement cases. These cases often result in settlements that enforce the validity and enforceability of the patents, preventing generic manufacturers from entering the market until the patents expire or the exclusivities are lifted[2][5].

Settlement Agreements

Settlement agreements in these cases typically involve the dismissal of claims and counterclaims without prejudice, with each party bearing its own costs and attorneys’ fees. These agreements also often include provisions that prevent the generic manufacturer from launching their product until the patents expire or under specific conditions[2].

Impact on Generic Entry

Delaying Generic Launch

The combination of active patents and FDA-granted exclusivities significantly delays the entry of generic versions of Akynzeo. This delay allows Helsinn Healthcare Sa to maintain market exclusivity and protect its revenue stream from the drug[1].

Economic Implications

The extended market exclusivity period has significant economic implications, both for the patent holder and for consumers. It allows the patent holder to continue generating revenue from the drug without competition from generics, but it also means that consumers may have to wait longer for potentially cheaper generic alternatives[1].

Expert Insights

Patent Quality and Innovation

Experts argue that the quality of patents, including their scope and validity, is crucial for innovation. Overly broad patents can lead to increased litigation costs and decreased incentives for innovation. However, patents like US 10,208,073, which are narrowly defined and valid, can provide the necessary protection to encourage further research and development[3].

Statistics and Examples

Patent Maintenance and Fees

The maintenance of patents, including the payment of fees, is an ongoing process. For example, the payment of maintenance fees for US 10,208,073 and other related patents ensures that these patents remain active and enforceable[1].

Clinical Impact

The combination of fosnetupitant and palonosetron hydrochloride, as described in the patent, has shown significant clinical benefits in preventing CINV. This has improved patient outcomes and quality of life, highlighting the practical impact of this patent[4].

Key Takeaways

  • Patent Scope and Claims: The patent 10,208,073 has narrowly defined claims that protect a specific solution composition, ensuring strong patent protection.
  • Patent Landscape: The patent is part of a broader portfolio protecting Akynzeo, with additional exclusivities granted by the FDA.
  • Litigation and Settlements: Patent infringement cases and settlements enforce the validity of the patents and delay generic entry.
  • Economic and Clinical Impact: The patent protects significant revenue for Helsinn Healthcare Sa and provides clinical benefits for patients.

FAQs

What is the primary use of the solution described in US 10,208,073?

The primary use of the solution is for the prevention of chemotherapy-induced nausea and vomiting (CINV).

How does the patent protect the market exclusivity of Akynzeo?

The patent, along with FDA-granted exclusivities, prevents other companies from marketing generic or bioequivalent versions of Akynzeo until the patents expire or the exclusivities are lifted.

What are the key components of the solution described in the patent?

The solution includes the chloride hydrochloride salt of fosnetupitant, palonosetron hydrochloride, and dexamethasone.

How long will the patent remain active?

The patent is set to expire in May 2032, approximately 7 years from now[1].

What is the impact of patent litigation on generic entry?

Patent litigation and settlements can significantly delay the entry of generic competitors into the market, allowing the patent holder to maintain market exclusivity.

Cited Sources

  1. Pharsight: Akynzeo patent expiration - Pharsight
  2. Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
  3. SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN
  4. Google Patents: US10208073B2 - Google Patents
  5. RPX Corporation: Case 3:22-cv-04635-ZNQ-LHG Document 1 Filed 07/18/22 Page 1 ...

More… ↓

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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 10,208,073 ⤷  Try for Free 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 ⤷  Try for Free
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes 10,208,073 ⤷  Try for Free 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 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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

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