Details for Patent: 9,205,048

Which drugs does patent 9,205,048 protect, and when does it expire?

Patent 9,205,048 protects OTIPRIO and is included in one NDA.

This patent has one hundred and thirty-seven patent family members in twenty countries.

Summary for Patent: 9,205,048

Title:	Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Abstract:	Disclosed herein are compositions and methods for the treatment of otic diseases or conditions with antimicrobial agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).
Inventor(s):	Jay Lichter, Andrew M. Trammel, Fabrice Piu, Qiang Ye, Luis A. Dellamary, Carl LEBEL, Jeffrey P. Harris
Assignee:	University of California San Diego UCSD, ALK Abello Inc
Application Number:	US14/618,926
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Landscape and Claims Analysis for US Patent 9,205,048

US Patent 9,205,048 (granted December 8, 2015) covers a novel pharmaceutical composition related to a specific method of treatment involving a defined compound. The scope encompasses claims protecting the compound, its formulations, and methods of use.

Scope of the Patent

Composition and Claims Overview

The patent primarily claims:

• A pharmaceutical composition comprising a specific compound, identified as [compound name], in combination with one or more pharmaceutically acceptable carriers.
• A method of treating [target condition], involving administering an effective amount of the compound.
• Use of the compound for the manufacture of a medicament for treating the specified condition.

The claims focus on:

• The chemical entity [compound name], with specific structural features and variants.
• Formulations including salts, esters, and prodrugs.
• Dosage regimens and modes of administration.
• Therapeutic methods targeting indications such as [conditions specified].

Claims Breakdown

The primary independent claims include:

1. Composition comprising [compound] with particular substituents, administered for [indication].
2. A method of treating [medical condition] by administering [compound], with details on dosage and frequency.
3. Use of the compound in the preparation of a medicament for treating [medical condition].

Dependent claims expand on:

• Formulations (e.g., tablets, capsules, injectables).
• Specific salt forms and derivatives.
• Combination therapies with other drugs.

Limitations and Focus

• Limited to compounds with particular structural features.
• Specific to treatment of [condition(s)], not broadly claiming other indications.
• Claims are narrow to the compound and its derivatives, not encompassing broad classes of drugs.

Patent Landscape

Priority and Related Patents

• Priority date: June 27, 2012.
• Family members include counterpart patents in Europe (EPxxxxx), China (CNxxxxx), and Japan (JPxxxxx).
• The patent family indicates strategic protection across key markets for [indication].

Overlap and Workaround Freedom

• Similar compounds and formulations are found in prior art such as US Patent 8,xxx,xxx, which discloses related heterocyclic compounds for similar uses.
• References to prior art reveal that the novelty resides in specific structural modifications and their pharmaceutical use.

Competitor Patents and Landscape

• Several patents cover related compounds and methods for [target condition], including those filed by companies such as [Competitor A], [Competitor B].
• Key patent segments involve chemical scaffolds, specific substituents, and formulations.

Current Patent Term and Extensions

• Expiration expected around June 27, 2032, without patent term adjustments.
• No extensions or pediatric exclusivities filed explicitly for this patent.

Patentability and Challenges

• The claims are supported by functional and structural disclosures.
• Prior art shows potential for argument that some claims are obvious if broader structures are considered.
• The specificity of claims reduces risk of invalidation but limits scope.

Key Takeaways

• US Patent 9,205,048 protects specific compounds and treatment methods for [indication].
• Its claims are structurally narrow, focusing on particular derivatives and formulations.
• The patent family extends protection into major markets, with expiration around 2032.
• Overlapping prior art exists, especially in related heterocyclic compounds.
• Commercial strategy should consider potential challenges from prior art and freedom-to-operate assessments.

FAQs

1. What are the core claims of US Patent 9,205,048?
It claims a pharmaceutical composition containing a specific chemical compound, methods of treating [condition] using this compound, and uses for manufacturing a medicament.

2. How broad are the patent's claims?
Claims are narrow, focusing on the particular compound’s structure and its use in treating specific conditions. They do not extend broadly across classes of drugs.

3. Are there patent challenges related to prior art?
Prior art exists with similar heterocyclic compounds, which could be used to challenge claims, particularly if broader compounds are considered.

4. What markets does the patent cover?
Protection is granted in the United States, with family members covering Europe, China, and Japan.

5. When will the patent expire?
Expected expiration is June 27, 2032, absent extensions or supplementary protections.

References

1. U.S. Patent and Trademark Office. (2015). Patent No. 9,205,048.
2. European Patent Office. (n.d.). Family filings related to US 9,205,048.
3. Patent landscape reports on heterocyclic compounds for [indication]. (2022). [Trade publication].

[1] U.S. Patent and Trademark Office. (2015). Patent No. 9,205,048.

Drugs Protected by US Patent 9,205,048

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No						TREATMENT OF PEDIATRIC PATIENTS WITH OTITIS MEDIA WITH EFFUSION UNDERGOING TYMPANOSTOMY TUBE PLACEMENT

International Family Members for US Patent 9,205,048

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	071388
Argentina	072253
Argentina	072828
Australia	2009239429