Details for Patent: 10,517,951

Which drugs does patent 10,517,951 protect, and when does it expire?

Patent 10,517,951 protects ABILIFY ASIMTUFII and is included in one NDA.

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

Summary for Patent: 10,517,951

Title:	Injectable preparation
Abstract:	An object of the present invention is to provide a storage-stable injectable preparation comprising a composition comprising a poorly soluble drug as an active ingredient and a dispersion medium. Another object of the present invention is to provide a compact, lightweight prefilled syringe by filling a syringe with the injectable preparation. The present invention provides an injectable preparation comprising a composition comprising a poorly soluble drug, a dispersion medium, and a specific suspending agent, the composition having a viscosity of 40 pascal-seconds or more in at least one point in the shear rate range of 0.01 to 0.02 sand having a viscosity of 0.2 pascal-seconds or less in at least one point in the shear rate range of 900 to 1,000 s, as measured.
Inventor(s):	Kaneko Daiki, Matsuda Takakuni, Hoshika Yusuke
Assignee:	OTSUKA PHARMACEUTICAL CO., LTD.
Application Number:	US16156958
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 10,517,951

Introduction to the Patent

United States Patent 10,517,951, titled "Injectable preparation," was issued on December 31, 2019, to inventors Kaneko Daiki, Matsuda Takakuni, and Hoshika Yusuke, and is assigned to Otsuka Pharmaceutical Co., Ltd.[2][4].

Overview of the Invention

This patent pertains to the development of a highly storage-stable injectable preparation that contains a poorly soluble drug, specifically aripiprazole, which is the active ingredient in Abilify, a medication used to treat schizophrenia, bipolar disorder, and other mental health conditions.

Key Components of the Patent

Composition and Formulation

The patent describes an injectable preparation that includes aripiprazole or a salt thereof, along with various excipients such as polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), and carboxymethyl cellulose. These components are crucial for enhancing the solubility and stability of the drug[1].

Particle Diameter and Concentration

The patent specifies that the particle diameter of the primary particles in the preparation is controlled to ensure optimal stability and bioavailability. The concentration of the drug and excipients is also carefully defined to achieve the desired therapeutic effect[1].

Storage Stability

One of the primary objectives of this invention is to provide an injectable preparation that remains stable over an extended storage period. This is achieved through the use of specific excipients and by controlling the particle size and concentration of the drug[1].

Claims of the Patent

Scope of Protection

The patent claims cover a broad range of aspects related to the injectable preparation, including:

• The composition of the preparation, which includes aripiprazole or its salt, and specific excipients.
• The method of preparing the injectable solution.
• The storage conditions and stability of the preparation.
• The particle size and concentration of the drug particles[1].

Specific Claims

The claims are detailed and include specifications such as:

• The use of polyethylene glycol 400 as a solvent.
• The inclusion of carboxymethyl cellulose and polyvinylpyrrolidone as stabilizers.
• The control of particle diameter to ensure uniformity and stability.
• The sustained-release profile of the preparation[1].

Patent Expiration and Generic Launch

Expiration Date

The patent is set to expire on April 23, 2033. This expiration date is crucial for generic manufacturers, as it marks the time when they can legally produce and market generic versions of the drug without infringing on the patent[2][4].

Impact on Generic Launch

Until the patent expires, Otsuka Pharmaceutical Co., Ltd. retains exclusive rights to manufacture and market this specific injectable preparation of aripiprazole. After the patent expires, generic manufacturers can file Abbreviated New Drug Applications (ANDAs) to gain approval for their generic versions, provided they demonstrate bioequivalence to the Reference Listed Drug (RLD)[2].

Broader Patent Landscape

Related Patents

There are several related patents that protect different aspects of aripiprazole formulations, including:

• Low Hygroscopic Aripiprazole: This patent (US8399469) focuses on the preparation of low hygroscopic forms of aripiprazole, which do not convert to hydrates or lose solubility over time[2][4].
• Methods for Administering Aripiprazole: Another patent (US8338427) describes methods for administering aripiprazole in an extended release profile without the need for complex microsphere formulations[2].

Global Patent Protection

While the focus here is on U.S. patents, it is important to note that Abilify Asimtufii is protected by patents in multiple countries. Understanding the global patent landscape is crucial for strategizing market entry and identifying potential generic launch opportunities in regions with weaker patent protection[4].

Strategic Implications

Design Around Strategies

Competitors may attempt to "design around" the patent by making minor changes to the formulation or manufacturing process that do not infringe on the patent claims. However, the broader scope of the claims in this patent makes it more challenging for competitors to do so without losing the desired functionality and characteristics of the product[3].

Market Entry

For generic manufacturers, understanding the full scope of patent protection and the expiration dates is vital for planning market entry. Identifying markets with weaker patent protection can provide opportunities for earlier generic launch[4].

Key Takeaways

• Patent Scope: The patent covers a broad range of aspects related to the injectable preparation of aripiprazole, including composition, preparation method, and storage stability.
• Expiration Date: The patent expires on April 23, 2033, marking the time when generic manufacturers can legally produce and market generic versions.
• Related Patents: Other patents protect different aspects of aripiprazole formulations, such as low hygroscopic forms and extended release methods.
• Global Protection: Understanding global patent protection is crucial for strategizing market entry and identifying potential generic launch opportunities.

FAQs

1. What is the main focus of United States Patent 10,517,951?

   • The main focus is on the development of a highly storage-stable injectable preparation containing aripiprazole.

2. What are the key components of the injectable preparation described in the patent?

   • The key components include aripiprazole or its salt, polyethylene glycol, polyvinylpyrrolidone, and carboxymethyl cellulose.

3. When is the patent set to expire?

   • The patent is set to expire on April 23, 2033.

4. How does the patent impact generic manufacturers?

   • Until the patent expires, generic manufacturers cannot legally produce and market generic versions of the specific injectable preparation of aripiprazole.

5. What are some related patents that protect other aspects of aripiprazole formulations?

   • Related patents include those for low hygroscopic forms of aripiprazole and methods for administering aripiprazole in an extended release profile.

Sources

1. US10517951B2 - Injectable preparation - Google Patents
2. Generic Abilify Asimtufii Availability - Drugs.com
3. Patent claims' scope – is bigger always better? Trends in the pharmaceuticals industry - Pearl Cohen
4. Abilify Asimtufii patent expiration - Pharsight

Drugs Protected by US Patent 10,517,951

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No	10,517,951		Y			MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No	10,517,951		Y			TREATMENT OF SCHIZOPHRENIA
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes	10,517,951		Y			TREATMENT OF SCHIZOPHRENIA
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes	10,517,951		Y			MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

International Family Members for US Patent 10,517,951

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	090776
Argentina	126033
Australia	2013253374
Australia	2017228608