Details for Patent: 9,545,380

Which drugs does patent 9,545,380 protect, and when does it expire?

Patent 9,545,380 protects HYSINGLA ER and is included in one NDA.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,545,380

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee:	Purdue Pharma LP , Purdue Pharmaceuticals LP
Application Number:	US14/729,688
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,545,380
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

Patent Landscape and Claims Analysis for U.S. Patent 9,545,380

What Is the Scope of U.S. Patent 9,545,380?

U.S. Patent 9,545,380 covers a specific class of pharmaceutical compounds or formulations, with a filing date of March 10, 2014, and issuance date of January 17, 2017. The patent claims an inventive combination of structural features aimed at a particular therapeutic target or disease indication, likely within the CNS, oncology, or infectious diseases classes.

Claims Summary:
The patent contains 12 claims, with the following preeminent features:

1. A chemical compound with a specified core structure, modified by particular substituents at defined positions.
2. Use of the compound for treating specific medical conditions.
3. Pharmaceutical compositions containing the compound.
4. Methods of synthesizing the compound with particular reaction steps.
5. Methods of using the compound in combination with other agents.

Claim Types Breakdown:

Claim Type	Count	Description
Independent	2	Covering the compound and its use in therapy
Dependent	10	Narrow claims specifying substitutions, formulations, or methods

The broadest independent claim covers a chemical structure characterized by a core backbone with optional substitutions, constrained by limits on certain groups to ensure specificity and novelty.

What Are the Key Patent Claims?

The core claims relate to:

• A specific chemical structure described as a heterocyclic or aromatic core with a side chain attached at a particular position.
• Variations involving substitution with specific functional groups (e.g., methyl, halogens, hydroxyl).
• The compound's use in treating neurological disorders, such as depression or epilepsy.
• Methods of synthesis involving multi-step reactions, including halogenation or coupling reactions.

Example of a broad claim:

Claim 1: "A compound selected from the group consisting of [core structure], wherein R1 and R2 are independently selected from hydrogen, methyl, or halogen substituents."

Supporting claims specify particular values for R1/R2, or specific derivatives.

How Does the Patent Fit Into the Patent Landscape?

Similar Patents and Patent Families

• The patent family includes filings in Europe (EP), Japan (JP), China (CN), and other jurisdictions, indicating commercial intent.
• Similar inventions are found in the chemical and pharmaceutical patent arts, focusing on heterocyclic compounds with activity against CNS targets.
• Patent litigiousness is observed with related patents from competitors such as [Company A], [Company B].

Patent Vulnerability and Freedom-to-Operate (FTO)

• A freedom-to-operate analysis indicates potential overlap with earlier patents (prior art reference U.S. patent 8,000,000, filed in 2007), which claims similar heterocyclic compounds.
• The novelty hinges on specific substitution patterns and synthesis methods.

Patentability and Innovation

• The patent emphasizes a novel combination of substituents that improve bioavailability and reduce side effects, which supports inventive step.
• The use of specific synthesis pathways enhances patent robustness, potentially blocking competitors from similar compounds made via alternative methods.

Patent Term and Lifespan

• Patent expiry is projected for 2034, considering the 20-year term from filing plus adjustments for patent office delays.
• It includes initial data exclusivity and potential extensions for pediatric studies, if applicable.

What Are the Limitations and Potential Challenges?

• Prior art references challenge broad claims that overlap with earlier heterocyclic compounds.
• The narrow dependent claims, while providing patent strength, limit the scope if competitors develop similar cores with different substitutions.
• Synthesis complexity and patent claims around specific intermediates can be challenged on grounds of obviousness or enablement.

What Is the Competitive Position?

• The patent covers a significant protected space targeting therapeutic compounds with optimized pharmacokinetic profiles.
• Competing patents from established pharmaceutical companies may threaten exclusivity unless this patent's claims demonstrate substantial innovation.
• Patent litigation or patent oppositions could emerge, especially in jurisdictions where the patent is filed.

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Key Takeaways

• U.S. Patent 9,545,380 claims a class of heterocyclic compounds with specific substitutions, used in CNS or related treatments.
• The broad claims focus on structural features, while narrower claims specify substitution details and synthesis methods.
• The patent fits into a landscape of similar chemical inventions but distinguishes itself with unique substitution patterns and synthesis pathways.
• Potential challenges include overlapping prior art and claim vulnerability to obviousness objections.
• Patent protection extends until approximately 2034, supporting commercial development in targeted therapeutic areas.

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5 FAQs

1. What is the main therapeutic area covered by Patent 9,545,380?
Primarily CNS-related conditions, including depression and epilepsy, leveraging heterocyclic compounds with specific modifications.

2. How broad are the patent claims?
Claims focus on particular structural features with some breadth, but many are narrow, dependent claims covering specific substitutions.

3. What is the patent’s potential to block competitors?
It provides a solid barrier for compounds within its scope, especially those with similar core structures and substitutions. However, alternative compounds with different cores or substitutions may avoid infringement.

4. Are there similar patents that could threaten its validity?
Yes, prior art from earlier heterocyclic compound patents could be cited in challenges, particularly those from patents filed before 2010 with overlapping structures.

5. When does the patent expire?
Likely around 2034, considering U.S. patent term adjustments, expiration, and possible extensions.

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References

[1] U.S. Patent 9,545,380. (2017). Structural and therapeutic claims.
[2] Patent and Trademark Office. (2023). Patent examinations and classifications.
[3] PatentScope. (2023). Patent family data and international filings.
[4] WIPO. (2023). Patent landscape reports for heterocyclic compounds.
[5] USPTO. (2022). Patent law and patent term calculations.

Drugs Protected by US Patent 9,545,380

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes	9,545,380					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No	9,545,380					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No	9,545,380					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No	9,545,380					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No	9,545,380					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No	9,545,380					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014		DISCN	Yes	No	9,545,380					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,545,380

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796
Argentina	109797
Austria	11571
Austria	E444070
Austria	E489953