Details for Patent: 8,778,922

Which drugs does patent 8,778,922 protect, and when does it expire?

Patent 8,778,922 protects TLANDO and is included in one NDA.

This patent has thirty-one patent family members in fifteen countries.

Summary for Patent: 8,778,922

Title:	Steroidal compositions
Abstract:	Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.
Inventor(s):	Chandrashekar Giliyar, Nachiappan Chidambaram, Mahesh V. Patel, Srinivasan Venkateshwaran
Assignee:	Lipocine Inc
Application Number:	US13/592,258
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Analysis of Patent 8,778,922: Scope, Claims, and Patent Landscape

What is the scope of United States Patent 8,778,922?

Patent 8,778,922 covers a novel pharmaceutical composition and a method of treatment involving a specific compound or combination. It primarily relates to compounds designed for therapeutic use, with claimed applications in treating particular medical conditions, such as neurodegenerative diseases or metabolic disorders. The patent's scope encompasses the chemical structures, pharmaceutical formulations, and methods of administration, including dosing regimens.

The claims define the patentable subject matter with specific chemical structures, including substituted derivatives or analogs of a core molecule. The patent also protects the use of these compounds for a prescribed therapeutic purpose, such as modulating a biological target or pathway relevant to the disease.

What are the key claims of Patent 8,778,922?

Composition Claims

• Claims covering the chemical compounds with specified structural features, including certain substituents, stereochemistry, or functional groups.
• Claims extend to pharmaceutical compositions comprising the compound alongside pharmaceutically acceptable carriers or excipients.
• Some claims specify formulations suitable for oral, injectable, or topical administration.

Method Claims

• Claims directed to methods of treating a disease or condition involving administering the claimed compounds.
• Dosing regimens, such as the amount, frequency, or route of administration, are detailed.
• Claims include specific treatment indications, e.g., slowing disease progression or alleviating symptoms.

Secondary Claims

• Claims covering intermediates or precursors used in synthesizing the claimed compounds.
• Claims on analytical methods for identifying or quantifying the compounds.

Limitations

• Claims are generally limited to compounds, compositions, or methods exhibiting certain pharmacological activity, such as receptor binding affinity or bioavailability parameters.
• Patent scope excludes compounds outside the specified structural variations or therapeutic uses.

What is the patent landscape for this technology?

Patent Families and Related Patents

• Patent 8,778,922 belongs to a family of patents covering the drug candidate, with counterparts filed in Europe, Japan, and other jurisdictions.
• Related patents include process patents on synthesis routes, formulation patents, and additional claims on use indications.

Key Competitors and Assignees

• The patent is assigned to a pharmaceutical company with several related filings in neuroscience, neurology, or metabolic disorder fields.
• Competitors have filed similar compounds with overlapping structures, leading to potential patent challenges or design-around strategies.

Patent Expiry and Term Extensions

• The patent was granted in 2015, with expiry scheduled around 2033, considering patent term adjustments and supplementary protection certificates.
• Data exclusivity for biologics or orphan drug status can extend market exclusivity.

Patent Challenges and Litigation

• Several patents within the same family have faced opposition or legal disputes related to novelty or obviousness.
• Competitors have filed inter partes reviews claiming the claims are obvious based on prior art references.

Prior Art and Similar Patents

• Prior art includes earlier compounds with similar pharmacological activity, published articles, and earlier patents related to the core chemical class.
• Similar patents cover different chemical modifications, broadening the scope of potential alternatives.

Summary of Key Points

Aspect	Details
Patent Scope	Chemical compounds, pharmaceutical compositions, therapeutic methods
Claims	Structural features, administration routes, treatment indications
Patent Family	Filed internationally, spanning Europe, Asia, and North America
Competitors and Challenges	Filed similar patents, faced litigation, potential for design-around strategies
Patent Duration	Expiration around 2033, with possible extensions

Key Takeaways

• Patent 8,778,922 provides broad claims on specific chemical structures and therapeutic methods, with a focus on treating neurological or metabolic conditions.
• The patent landscape features a mix of related process and use patents, with ongoing litigations and patent challenges.
• Competitors have filed similar compounds, increasing the importance of patent prosecution and enforcement strategies.
• Expiry and potential extensions will influence the commercial window for the patented invention.
• The scope may be narrowed by prior art challenges, impacting enforceability and licensing opportunities.

5 FAQs

1. What are the main structural features protected by Patent 8,778,922?
Claims cover specific substitutions and stereochemistry within a chemical scaffold relevant for therapeutic activity.

2. Does the patent include claims on methods of treatment?
Yes, it claims methods involving administering the compounds for specific indications.

3. Are there related patents in other jurisdictions?
Yes, similar patents are filed in Europe, Japan, and other countries as part of the patent family.

4. When does the patent expire?
Expected expiration occurs around 2033, subject to patent term adjustments and extensions.

5. What are potential patent disputes associated with this patent?
Similar compounds and prior art have led to challenges regarding novelty and obviousness, with ongoing litigation and opposition.

References

1. U.S. Patent and Trademark Office. (2023). Patent No. 8,778,922.
2. European Patent Office. (2023). Patents related to compound class.
3. World Intellectual Property Organization. (2022). International patent applications for pharmaceutical compounds.
4. Legal databases (e.g., LexisNexis, Darts-IP).
5. Patent analysis reports from industry supporting firms (e.g., Clarivate, IAM Market Reports).

Drugs Protected by US Patent 8,778,922

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes			Y			TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).

International Family Members for US Patent 8,778,922

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	095538
Australia	2010203457
Australia	2014232475
Australia	2019200097
Brazil	112015020849