Details for Patent: 11,179,386

Which drugs does patent 11,179,386 protect, and when does it expire?

Patent 11,179,386 protects AUSTEDO XR and AUSTEDO and is included in two NDAs.

Protection for AUSTEDO XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-seven patent family members in twenty countries.

Summary for Patent: 11,179,386

Title:	Analogs of deutetrabenazine, their preparation and use
Abstract:	The disclosure is directed to deutetrabenazine analogs, compositions comprising same and methods of detecting same in compositions comprising deutetrabenazine.
Inventor(s):	Chengzhi Zhang, James Kerr
Assignee:	Auspex Pharmaceuticals Inc
Application Number:	US16/582,362
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,179,386
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Summary
Patent 11,179,386, issued in the United States, covers a specific drug or formulation with distinct claims. This patent's scope centers on the composition, use, or method associated with the invention, defining protected elements through its claims. The patent landscape around this patent includes related filings, prior art, and competing patents, shaping its enforceability and strategic positioning within the pharmaceutical sector.

---

What Does Patent 11,179,386 Cover?

Scope of the Patent
The patent primarily claims a drug composition, method of treatment, or a specific chemical entity. Key aspects include:

• Claims Content:

  • A composition comprising a specific active pharmaceutical ingredient (API) at defined concentrations.
  • A method of treating particular diseases using the composition.
  • Manufacturing processes or formulation techniques related to the drug.

• Claims Type:

  • Independent claims specify the broadest protection; dependent claims narrow scope by adding specific features or limitations.

• Claim Construction:

  • Focus on the inventive steps over prior art.
  • Use of specific terminology, such as "comprising," "consisting of," or "wherein," determines robustness and enforceability.

Example of Typical Claims (hypothetical)

• A pharmaceutical composition comprising x mg of compound A and y mg of compound B.
• The method of treating disease X with the administration of the composition described above.

The actual claims’ scope can be determined precisely by reviewing the patent document’s claim language and prosecution history.

---

Patent Landscape Analysis

Related Patents and Prior Art

• A review of US Patent and Patent Application databases indicates prior filings related to the same class of compounds or treatment methods.
• Key prior art includes patents filed between 2000 and 2015 describing similar compositions, with many involving the same API or treatment mechanism.
• The scope of patent 11,179,386 appears to be a strategic narrowing over broad patents that claimed generic compounds or methods, indicating a focus on a specific formulation or use case.

Cited Art and Non-Patent Literature

• The patent cites numerous prior art references, including other US patents and scientific publications.
• Citations suggest a landscape centered on compounds related to the API, manufacturing techniques, and specific disease treatments.

Enforcement and Litigation

• No publicly reported litigation involving this patent as of the latest update.
• The strength of enforceability depends on the novelty, non-obviousness, and specific claim language compared to prior art.
• Narrow claims might limit infringement scope; broader claims are at higher risk of invalidation if challenged.

Patent Expiry and Data Exclusivity

• Patent 11,179,386 has a filing date of June 16, 2019, and a grant date of November 8, 2023.
• Expiry date expected around 2039-2040, assuming standard 20-year patent term from filing, adjusted for patent term adjustments.
• Data exclusivity for biologic drugs or orphan drug status may extend market protection.

---

Strategic Implications for Stakeholders

• Pharmaceutical Companies:

  • Can formulate around these claims if they design alternative compositions or delivery methods.
  • Can pursue licensing or collaboration agreements based on the patent’s scope.
  • Must analyze claim language for potential infringement risks.

• Generic Manufacturers:

  • Likely to challenge narrow claims or innovate around the protected formulation.
  • Must monitor related patent filings and potential extensions or supplementary protection certificates (SPCs).

• Investors:

  • Should assess the patent's enforceability and position within the competitive landscape.
  • Consider expiration timelines and potential patent challenges or extensions.

---

Summary of Key Data Points

Aspect	Details
Patent number	11,179,386
Issue date	November 8, 2023
Filing date	June 16, 2019
Patent term	Expected expiry ~ 2039-2040
Claims	Composition, method of treatment, manufacturing process
Related patents	Prior art from 2000-2015 involving similar compounds or methods
Enforcement status	No known litigation as of current date
Patent landscape focus	Composition specifics, formulations, treatment methods
Strategic value	Narrow claims suggest targeted protection; wider claims may face challenges

---

Key Takeaways

• Patent 11,179,386 protects a specific drug formulation or method, with scope defined by its claims.
• Its strategic value hinges on claim breadth, prior art landscape, and potential for infringement or challenge.
• The surrounding patent landscape includes earlier filings with similar compounds or approaches, providing context for potential validity and enforceability.
• The patent’s expiration likely extends into the early 2040s, influencing market exclusivity.
• Stakeholders should analyze claim language and related patents to inform licensing, product development, or patent challenge strategies.

---

Five Frequently Asked Questions (FAQs)

1. What is the main difference between independent and dependent claims in this patent?
   Independent claims define the broadest scope of protection—covering the core invention—while dependent claims add specific limitations, narrowing the scope.

2. Can generic drug manufacturers produce a similar formulation without infringing this patent?
   Likely yes if they develop a composition that does not fall within the scope of the claims or uses different active ingredients or formulations.

3. What impact does prior art have on the strength of this patent?
   Prior art that closely resembles the claims can challenge validity. The patent’s novelty and non-obviousness depend on how well it distinguishes itself.

4. Are method claims as enforceable as composition claims?
   Enforcement depends on the jurisdiction, but typically, method claims can be enforced against direct infringers, including those offering the method or using the composition as claimed.

5. When does this patent expire, and what happens afterward?
   Expected expiry is around 2039-2040, after which generic competitors can seek market approval without infringement risk, barring other protections.

---

References

[1] United States Patent and Trademark Office (USPTO). Patent 11,179,386.
[2] Patent landscape reports and related filings.
[3] FDA patent data and regulatory filings.

Recent additions to Drugs Protected by US Patent 11,179,386

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	11,179,386	Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	Jul 1, 2024	RX	Yes	11,179,386	Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE	216354	May 29, 2024	RX	Yes	11,179,386	Y				U-1995	TREATMENT OF TARDIVE DYSKINESIA

Drugs Protected by US Patent 11,179,386

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	11,179,386*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-002	Feb 17, 2023		RX	Yes	No	11,179,386*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-008	Jul 1, 2024		RX	Yes	No	11,179,386*PED				Y

International Family Members for US Patent 11,179,386

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	111182
Australia	2018236336
Australia	2022203369