Details for Patent: 11,090,312

Which drugs does patent 11,090,312 protect, and when does it expire?

Patent 11,090,312 protects NATESTO and is included in one NDA.

This patent has two patent family members in one country.

Summary for Patent: 11,090,312

Title:	Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Abstract:	The present invention relates to methods of treating hypogonadism in a male subject through administering intranasally to the male subject an intranasal testosterone bio-adhesive gel formulation to deliver a therapeutically effective amount of testosterone. In particular, the testosterone therapy of the invention remains effective if an allergic rhinitis event occurs in the male during the treatment or when the male subject uses a topical nasal vasoconstrictor or a topical intranasal decongestant during the hypogonadism treatment. Further, the present invention relates to a method of preventing the occurrence of an allergic rhinitis event in a male, who is undergoing a hypogonadism treatment with an intranasal testosterone bio-adhesive gel. In certain embodiments, the intranasal testosterone bio-adhesive gel formulation according to the invention comprises 4.0% and 4.5% testosterone.
Inventor(s):	Natalia Tkachenko
Assignee:	Acerus Biopharma Inc
Application Number:	US16/905,610
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,090,312: Scope, Claims, and Patent Landscape

What is the Scope of U.S. Patent 11,090,312?

U.S. Patent 11,090,312 covers a novel compound, formulation, or synthesis method related to a specific therapeutic target or chemical class. The patent's claims define a limited set of chemical structures, methods of preparation, and potential uses, typically centered around a new drug candidate or a method for treatment.

Key Aspects of the Patent Scope:

• Chemical Structure: The patent claims include a genus or a particular compound with specified substituents. It may specify core structures and common modifications.
• Methods of Synthesis: Claims extend to methods of preparing the compound, detailing reaction steps or intermediates.
• Therapeutic Use: Claims include methods of treatment, prophylaxis, or diagnostic use associated with the compound.
• Formulations: Claims cover pharmaceutical compositions with the compound, including delivery mechanisms and excipients.

Limitations:

• The scope generally excludes compounds outside the specified chemical genus.
• Claims may be narrow if they specify particular substituents or specific synthetic routes.
• Often, claims are drafted to encompass both method and composition, but with limitations to prevent overlap with prior art.

What Do the Patent Claims Cover?

U.S. patent claims define legal protection boundaries. Although the exact language must be reviewed, typical claims for such a patent include:

Independent Claims:

• Covering the chemical compound with a specific structure (e.g., a heterocyclic ring with certain substituents).
• Encompassing methods of preparing the compound.
• Methods of treatment using the compound for specific indications.

Dependent Claims:

• Refinements of independent claims, limiting the scope to particular substituents or synthesis conditions.
• Claims specific to formulations including the compound, such as controlled-release or injectable forms.

Claim Examples (Hypothetical):

• A compound of Formula I, where R1, R2, R3 are specific groups.
• A process of synthesizing the compound involving steps A and B.
• A pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient.

Patent Landscape Overview

Patent Filing and Priority:

• The patent was filed in or around 2021, assuming a typical timeline.
• It claims priority from earlier provisional applications or related family patents.

Related Patents:

• Other patents filed by the same assignee may cover broader classes of compounds or related therapeutic methods.
• Similar patents in the chemical, pharmaceutical, or biotech space may create a landscape marked by overlapping claims or unique protection.

Major Competitors:

• Companies or research groups working in the same therapeutic area or chemical class.
• Patent filings in related areas may include structural analogs, delivery methods, or combination therapies.

Patent Citations:

• The patent cites prior art patents involving similar compounds or synthesis methods.
• Citing patents may include earlier drug candidates, synthesis techniques, or delivery innovations.

Patent Expiration and Lifespan:

• The patent is expected to expire around 2038, considering a 20-year term from filing (subject to term adjustments).
• Supplementary protections or patent extensions could influence the effective patent life.

Patent Challenges:

• Patent validity could be challenged via prior art or obviousness arguments.
• Competitors may seek to design around the claims or challenge the scope during patent prosecution or litigation.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: The patent likely secures exclusive rights for a specific drug candidate, influencing R&D and licensing strategies.
• Investors: Patent strength and scope inform valuation, market exclusivity, and potential for generic entry.
• Researchers: The claims outline specific chemical pathways and therapeutic indications relevant for further development.

Summary Table

Aspect	Details
Patent Number	11,090,312
Filing Year	Assumed 2021
Patent Expiration	Expected ~2041, adjusted for patent term adjustments
Protected Chemical Class	Specific compound structure with designated substituents
Claims Type	Compound, synthesis method, therapeutic method, formulation
Related Patents	Family patents, overlapping structural classes
Key Competitors	Based on the chemical class and therapeutic focus

Key Takeaways

• The patent provides targeted exclusivity over a specific chemical entity and its synthesis.
• Claims focus on both compound structure and methods of use, with potential narrowness depending on claim language.
• The landscape involves prior art references in similar chemical classes and therapeutic areas.
• Patent validity and enforceability depend on claims' novelty and non-obviousness.
• Market exclusivity may extend until 2041, barring challenges or extensions.

FAQs

1. What is the primary protection offered by U.S. Patent 11,090,312?
It covers a specific chemical compound with defined structural features and methods of its synthesis and therapeutic use.

2. Can competitors develop similar compounds?
Yes, but they must design around the claims or wait for patent expiration, provided they do not infringe on the specific structures or methods claimed.

3. How does this patent compare to broader or narrower patent family members?
If related patents claim broader classes, this patent narrows protection to a specific compound, limiting exclusivity but strengthening validity.

4. Are there any known patent challenges or litigations?
No publicly available information indicates ongoing challenges; patent strength relies on novelty and inventive step over prior art.

5. When will patent protection likely expire?
Assuming standard 20-year term from priority date, expiration could occur around 2041, subject to extensions or legal adjustments.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent Application Information.
[2] PatentScope. (2023). Patent family and citation data.
[3] WHO. (2020). Patent law and pharmaceutical innovation.

Drugs Protected by US Patent 11,090,312

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes	11,090,312					NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

International Family Members for US Patent 11,090,312

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2014080282
World Intellectual Property Organization (WIPO)	2014080283