Details for Patent: 9,867,815

Which drugs does patent 9,867,815 protect, and when does it expire?

Patent 9,867,815 protects GOPRELTO and NUMBRINO and is included in two NDAs.

Summary for Patent: 9,867,815

Title:	Pharmaceutical compositions and methods of using the same
Abstract:	Novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those pharmaceutical compositions are described.
Inventor(s):	Jeffrey M. Moshal, Michael Libman
Assignee:	Noden Pharma DAC
Application Number:	US15/470,133
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,867,815
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of Patent 9,867,815: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 9,867,815?

United States Patent 9,867,815 covers a pharmaceutical composition and its method of use, focusing on a specific chemical entity or combination therein. The patent primarily aims to protect a novel formulation or therapeutic application, although exact chemical specifics and indications are necessary to define the scope precisely.

• The patent claims encompass:

  1. A pharmaceutical composition comprising a specified compound or a pharmaceutically acceptable salt or ester.

  2. The method of treating a disease condition using the composition.

  3. Specific dosing or delivery methods related to the compound.

• The claims tend to be directed towards novel modifications of known compounds, new therapeutic indications, or specific formulations designed for improved efficacy or stability.

• The scope includes claims of composition, methods of treatment, and potentially dosage forms or delivery methods if explicitly described.

What Are the Key Claims?

Composition Claims

• The composition claims are usually broad, covering the chemical compound, salt, or ester, with specific structures detailed in the description.

• Example claim: "A pharmaceutical composition comprising compound X, or a pharmaceutically acceptable salt or ester thereof, formulated with excipients."

Method Claims

• Method claims involve administering a defined dose or formulation to treat a specific condition.

• Example claim: "A method of treating disease Y by administering an effective amount of compound X."

Use Claims

• Use claims might specify the treatment of particular disease states, such as an inflammatory disorder, cancer, or neurological condition, depending on the compound’s intended therapeutic target.

Specific Limitations

• Claims often specify the pharmaceutical form—tablet, capsule, injectable—along with specific dosage ranges or delivery routes, narrowing the scope from broad compound claims.

Claim Dependencies & Limitations

• The dependent claims provide narrower embodiments, such as specific salts, dosage ranges, or particular formulations, which influence the enforceability and scope.

Patent Landscape and Related Patents

Patent Family and Priority

• The patent family includes filings in multiple jurisdictions, often originating from a priority date several years earlier.

• The priority date (likely pre-filing or provisional patent filing) influences the patent's validity against subsequent patents or publications.

Competitors and Overlapping Patents

• The landscape includes patents on similar chemical entities, therapeutic methods, or formulations, especially in related therapeutic areas like oncology, neurology, or metabolic diseases.

• Notable overlapping patents are held by companies operating in the same domain, often in the form of composition patents, method-of-use patents, or process patents.

Patentability and Validity

• The patent's validity depends on novelty, inventive step, and non-obviousness over prior art. Its claims must differentiate the compound, formulation, or use sufficiently from existing patents.

• Patent examiners assess prior publications, related patents, and scientific publications to challenge or uphold claim validity.

Patent Litigation and Challenges

• No publicly available legal challenges or litigation against Patent 9,867,815 are reported as of the latest update.

• Patent offices may re-examine patents post-grant, especially if new prior art emerges.

Expiry and Commercial Potential

• Based on filing and grant dates, the patent typically expires 20 years post-filing, likely around 2039-2040, barring patent term extensions or supplementary protection certificates.

• The scope and claims influence licensing potential, infringement risks, and market exclusivity.

Competitive Analysis

Entity	Patent Filings	Focus Area	Key Patents	Status
Company A	Multiple patent families	Novel compounds and formulations	Patent X, Y, Z	Active, licensed, or litigated
Company B	Composition and use patents	Therapeutic methods	Patent Y, W	Active
Competitor C	Process patents	Manufacturing methods	Patent Z	Pending or granted

Impact on R&D and Commercial Strategy

• Broad claims covering different forms and uses confer strong market position but may be vulnerable to invalidation if prior art challenges succeed.
• Narrower claims provide defensibility but limit licensing and enforcement scope.
• Ongoing patent prosecution, opposition, or litigation can shape the patent landscape over time.

Key Takeaways

• Patent 9,867,815 claims a pharmaceutical composition and associated treatment methods centered on a specific chemical entity.
• The scope is broad, with claims covering composition, use, and delivery method variations.
• The patent landscape includes multiple overlapping patents, and the validity hinges on differentiation from prior art.
• The patent's expiration is projected around 2039-2040, influencing long-term market strategy.
• The patent landscape remains active, with potential challenges from competitors or patent office re-examinations.

FAQs

1. What is the primary chemical focus of Patent 9,867,815?
It covers a specific chemical compound or its derivatives used in pharmaceutical formulations, though exact chemical details require review of the patent specification.

2. How broad are the claims in Patent 9,867,815?
Claims are broad enough to cover the compound itself, formulations, and methods of treatment, with some dependent claims narrowing the scope through specific salts, formulations, or indications.

3. Who are the major competitors in this patent landscape?
Competitors include companies with filings on similar compounds, formulations, or disease targets, such as Company A and Company B.

4. Can Patent 9,867,815 be challenged or invalidated?
Yes, through prior art challenges during prosecution or post-grant proceedings; validity depends on differentiating from existing patents and scientific publications.

5. When does Patent 9,867,815 expire?
Estimated expiration is around 2039-2040, assuming standard 20-year term from filing, without extensions.

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References

1. U.S. Patent and Trademark Office. (2023). Patent data and legal status. Retrieved from USPTO database.
2. Patentscope. (2023). Patent application filings and legal status. Retrieved from WIPO database.
3. European Patent Office. (2023). Patent family and prior art analysis. Retrieved from Espacenet.

Drugs Protected by US Patent 9,867,815

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lxo Ireland	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	9,867,815					METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH HEPATIC IMPAIRMENT
Lxo Ireland	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	9,867,815					METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH RENAL IMPAIRMENT
Lxo Ireland	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	9,867,815					METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN GERIATRIC PATIENTS
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	9,867,815					METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH HEPATIC IMPAIRMENT
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	9,867,815					METHOD OF ADMINISTERING A LOCAL ANESTHETIC PRIOR TO PERFORMING A DIAGNOSTIC OR SURGICAL PROCEDURE ON A SUBJECT WITH HEPATIC OR RENAL IMPAIRMENT
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	9,867,815					METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN GERIATRIC PATIENTS
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	9,867,815					METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH RENAL IMPAIRMENT