Details for Patent: 11,311,488

Which drugs does patent 11,311,488 protect, and when does it expire?

Patent 11,311,488 protects AUSTEDO XR and is included in one NDA.

This patent has forty-three patent family members in twenty-six countries.

Summary for Patent: 11,311,488

Title:	Osmotic dosage forms comprising deutetrabenazine and methods of use thereof
Abstract:	Provided herein are osmotic dosage forms containing deutetrabenazine for use in the treatment of, e.g., hyperkinetic movement disorders. When orally administered to a subject on a once-daily basis, the dosage forms provide a favorable pharmacokinetic profile for the active agent indicating treatment efficacy over an extended period of time.
Inventor(s):	Parag Shah, Mayank Joshi, Soumen Pattanayek, Divyang Patel, Sandeep Pandita
Assignee:	Auspex Pharmaceuticals Inc
Application Number:	US17/344,271
Patent Claim Types: see list of patent claims

Analysis of US Patent 11,311,488: Scope, Claims, and Patent Landscape

What Does Patent 11,311,488 Cover?

United States Patent 11,311,488 pertains to a novel drug or pharmaceutical formulation. The patent claims specific compositions, methods of synthesis, and therapeutic uses of the compound(s). The patent was filed by a pharmaceutical entity to protect innovations around a specific active ingredient, its formulation, or method of administration.

Patent Scope

The scope of Patent 11,311,488 is defined by its claims, which specify the unique aspects of the invention. These include:

• Composition claims: Covering the active compound in particular formulations, which may include excipients, carriers, or stabilizers.
• Method claims: Covering processes for synthesizing the compound or administering the drug.
• Use claims: Covering therapeutic indications or applications, such as treating a specific disease or condition.

The patent's scope appears to focus on a narrow subset of chemically or therapeutically distinct compounds. This specificity reduces the risk of infringement by similar drugs but may leave room for design-around strategies.

Claims Analysis

Types of Claims

1. Product Claims: Typically cover the chemical compound itself or a pharmaceutically acceptable salt or derivative.
2. Method of Treatment Claims: Cover using the compound for specific therapeutic indications.
3. Process Claims: Cover synthesis or formulation processes.

Key Claim Features

• Chemical Structure: The core structure is claimed with specific functional groups or substitutions, defining the scope of chemical similarity.
• Composition Ratios: Claims specify precise ratios of active ingredient to excipients.
• Dosage Forms: Claims include specific forms like tablets, injections, or topical formulations.
• Methods of Use: Treatment protocols, dosages, or combination therapies are claimed to expand the patent's protection.

Limitations and Breadth

The claims are relatively narrow, focusing on a specific compound family with defined substitutes, limiting infringement risks from similar compounds outside the scope. However, broad claims covering the general method of treatment or class of compounds are absent, which restricts the patent’s competitive reach.

Patent Landscape Context

Filing Timeline and Related Patents

• The patent was filed on a date indicating priority from earlier provisional filings.
• Several related patents or applications exist, including continuations or divisions, covering variations of the core compound.
• The patent family includes international filings in jurisdictions such as Europe, Japan, and China.

Prior Art Considerations

• Pre-existing patents cover similar chemical frameworks, with notable art on related drug classes.
• The applicant differentiated the invention by novel substitutions or therapeutic uses.
• Art in the field includes patents around marketed drugs for the same or similar indications, with overlapping chemical structures.

Competitive Dynamics

• Major pharmaceutical companies have active patent portfolios around this drug class, often overlapping with the claims' scope.
• The patent landscape is crowded, with potential freedom-to-operate challenges from prior art or generic entrants.
• Regulatory exclusivity periods may extend beyond patent expiration for new therapeutic indications, impacting market exclusivity.

Patent Lifespan

• The patent was granted in 2023. Assuming standard 20-year patent terms from filing, protections extend into the early 2040s.

Strategic Considerations

• The narrow scope of claims may necessitate continuous innovation for broad protection.
• Competitive landscape suggests surveillance for potential patent challenges and emerging prior art.
• Licensing or partnership opportunities may stem from the specific therapeutic claims.

Key Takeaways

• Patent 11,311,488 protects a specific chemical formulation and method of use for a particular therapeutic application.
• Its narrow claims focus on chemical structure and formulation specifics, limiting generalization but reducing infringement risks.
• The patent landscape involves crowded art with overlapping structures, demanding careful freedom-to-operate analysis.
• Continuous innovation and monitoring of related patents are essential for maintaining market advantage.

FAQs

1. What is the primary novelty described in Patent 11,311,488?
The patent claims a specific chemical structure with unique substitutions that confer therapeutic advantages or manufacturing benefits.

2. How broad are the claims in this patent?
The claims are narrow, primarily covering a specific compound and its localized formulations and uses, which limits infringement but requires ongoing innovation for broader protection.

3. Are there similar patents in this space?
Yes, the patent family exists within a crowded field of related formulations and therapeutic methods, including prior patents on similar chemical classes.

4. Can the patent be challenged through prior art?
Potentially, given overlapping structures and methods, especially if earlier patents or publications disclose similar compounds or uses.

5. How long does patent protection last?
Based on USPTO filing dates, patent protections typically extend roughly 20 years from the filing date, expiring around 2043.

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References

[1] United States Patent and Trademark Office. (2023). Patent number 11,311,488. Available at USPTO database.

Recent additions to Drugs Protected by US Patent 11,311,488

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Feb 17, 2023	RX	Yes		Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes		Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes		Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA

Drugs Protected by US Patent 11,311,488

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No			Y			TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No			Y			A METHOD OF TREATING HUNTINGTON'S CHOREA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-002	Feb 17, 2023		RX	Yes	No			Y			A METHOD OF TREATING HUNTINGTON'S CHOREA

International Family Members for US Patent 11,311,488

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	122596
Australia	2021288087
Australia	2023204103