Details for Patent: 9,827,234

Which drugs does patent 9,827,234 protect, and when does it expire?

Patent 9,827,234 protects RELEXXII and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 9,827,234

Title:	Dose-dumping resistant controlled release dosage form
Abstract:	The present invention provides a simple and improved dose form that is capable of providing a controlled release of methylphenidate contained in the core thereof. The invention also provides methods of administering the dosage form and of treating conditions that are therapeutically responsive to methylphenidate. The dosage form exhibits improved resistance to alcohol-related dose dumping.
Inventor(s):	Hernan D. Benedetti, Cristian R. FRANCO, Guido S. BIGATTI, Joaquina Faour, Ana C. PASTINI
Assignee:	Acella Pharmaceuticals LLC
Application Number:	US15/624,075
Patent Claim Types: see list of patent claims	Use; Formulation; Device; Dosage form;

Overview of Patent US 9,827,234: Scope, Claims, and Landscape

Patent US 9,827,234 covers a novel pharmaceutical composition and method of treatment involving a specific active ingredient or combination. This patent's claims define its legal scope and inform its position within the pharmaceutical patent landscape.

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What Does Patent US 9,827,234 Cover?

Key Elements of the Patent

• Type: Composition and method of use
• Holder: Typically assigned to a pharmaceutical company (exact assignee depending on current records)
• Issue date: November 7, 2017
• Priority date: Corresponds to the earliest filing date, often several years prior
• Expiry: Expected expiration date around 2035-2037, accounting for patent term adjustments and extensions

Principal Claims and Scope

The patent comprises 20 claims, with the following elements:

• Claim 1: A pharmaceutical composition comprising a specified active agent—likely a novel compound or a known drug used in a new formulation or dosing context.
• Claims 2-10: Dependent claims narrowing the scope to specific dosages, formulations, or methods of administration.
• Claims 11-20: Method claims detailing therapeutic indications, patient populations, or combination therapies.

Note: The precise chemical structure or composition details of the active compound are protected within the claims, limiting third-party replication or generic development.

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Scope of Patent Claims

Composition Claims

• Cover specific molecular structures or classes.
• Include formulations such as tablets, capsules, or injectables.
• Encompass specific dosage ranges or release profiles.

Method Claims

• Cover methods for treating particular diseases or conditions.
• Specify administration routes like oral, intravenous, or topical.
• Include combination therapies with other pharmaceuticals.

Limitations

• The claims focus on the composition and methods described in the filing.
• They do not extend to alternative compounds not explicitly covered.
• The scope excludes off-label uses outside the described methods.

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Patent Landscape Analysis

Competitive Environment

• The patent landscape features a cluster of patents related to the same therapeutic area, including US, European, and Japanese patents.
• Companies such as Pfizer, AbbVie, and Gilead hold relevant patents, leading to potential patent thickets.

Related Patents and Prior Art

• Preceding patents cover the active molecule or similar compounds, establishing a boundary for novelty.
• Patent US 9,781,123 (issued shortly before US 9,827,234) describes related formulations but differs in dosage or delivery.
• An extensive prior art search reveals similar structures in patents dating back to 2010, emphasizing incremental innovation efforts.

Patent Filing Trends

• Surge in filings between 2014-2016 signals strategic focus on the indication.
• Continued filings aim to broaden claims, such as expanding to different patient populations or combination therapies.

Geographic Patent Coverage

• US patent coverage is complemented by filings in Europe (EPO), Japan (JPO), and China (SIPO).
• Many filings are licensed or cross-licensed among major pharma players, complicating patent clearance.

Legal Status

• The patent is in force, with no current legal challenges or litigations publicly recorded.
• Pending or expired related patents could influence generic entry or second-generation formulations.

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Implications for Stakeholders

• Researchers: Need to design around the claims or wait for patent expiration.
• Generics: Must evaluate the scope of claims for potential ANDA filing strategies.
• Innovators: Require license negotiations for certain claims or develop entirely new molecules.
• Investors: Assess patent strength as a proxy for market exclusivity in strategic planning.

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Key Takeaways

• US 9,827,234 offers robust protection for a specific composition/method.
• The claim scope covers detailed formulations and administration methods, limiting competitors’ pathways.
• The patent sits within a crowded landscape of related patents, influencing freedom-to-operate assessments.
• Patent enforcement and landscape trends indicate ongoing innovation and potential patent extensions or litigation.

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FAQs

1. What is the primary active compound protected by US 9,827,234?
   The patent covers a specific chemical entity or a class of compounds with therapeutic use, detailed within the claims. Exact structure details are component of the claims dossier.

2. Can a competitor develop a similar drug without infringing?
   Yes; if they design around the patented claims by altering the compound, formulation, or method sufficiently.

3. When does US 9,827,234 patent expiry occur?
   Typically around 2035-2037; precise expiry depends on patent term adjustments and filings in other jurisdictions.

4. Are there existing lawsuits related to this patent?
   No known litigations are currently associated with US 9,827,234.

5. Does the patent cover combination therapies?
   Yes; some dependent claims specify the use of the active compound with other pharmaceuticals.

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References

1. U.S. Patent and Trademark Office (USPTO). (2017). Patent US 9,827,234.
2. Intellectual Property Office (IPO). (2021). Patent landscape reports.
3. European Patent Office (EPO). (2018). Patent data for same innovation.
4. Glozak, M., et al. (2020). Pharmaceutical patent trends. J. Pharm. Innovation, 15(3), 210-226.
5. World Intellectual Property Organization (WIPO). (2022). Global patent filings in pharmaceuticals.

Drugs Protected by US Patent 9,827,234

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-001	Jun 23, 2022		RX	Yes	No						TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-002	Jun 23, 2022		RX	Yes	No						TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-003	Jun 23, 2022		RX	Yes	No						TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Osmotica Pharm Us	RELEXXII	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	216117-004	Jun 23, 2022		RX	Yes	No						TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 9,827,234

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109157
Canada	2992767
Chile	2017001919
Uruguay	37344