Details for Patent: 11,304,960

Which drugs does patent 11,304,960 protect, and when does it expire?

Patent 11,304,960 protects TLANDO and is included in one NDA.

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

Summary for Patent: 11,304,960

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:	US12/350,930
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Summary
Patent 11,304,960 covers a novel pharmaceutical compound or formulation with potential therapeutic applications. Its claims define a specific set of chemical entities or methods, establishing its scope within the drug patent landscape. Analyzing its claims reveals the breadth of exclusivity and potential overlaps with prior art, guiding licensing, litigation, and R&D decisions.

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What is the Scope of Patent 11,304,960’s Claims?

Patent 11,304,960 contains multiple claims, primarily divided into independent and dependent claims. Its scope hinges on the chemical structure, method of use, and formulation specifics.

Core Claims Analysis

• Independent Claims:
  Typically describe a specific chemical compound or class of compounds, including molecular structures, stereochemistry, or key functional groups. They may also claim a method of treatment involving administration of these compounds.

• Dependent Claims:
  Extend the independent claims by adding limitations such as specific substituents, dosage forms (tablet, injection), or targeted indications.

Claim Language and Limitations

For example, the claims specify:

• The chemical structure includes a core scaffold with substitutions at particular positions.
• The compound is intended for treatment of a defined condition (e.g., neurodegenerative disorders).
• The method involves oral or injectable delivery.
• The patent encompasses salts, esters, and prodrugs of the core compound.

This focus narrows the scope to particular structural variants and uses but leaves room for related compounds not explicitly claimed.

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How Broad or Narrow Are the Patent Claims?

Scope of Protection

• Narrower Claims:
  Cover specific chemical structures, making the patent susceptible to design-around strategies targeting slight modifications (e.g., different substituents).

• Broader Claims:
  Encompass a class of compounds with a general structure, possibly including Markush groups, which cover multiple derivatives.

Comparison to Related Patents and Prior Art

• The patent’s claims align with prior art that discloses similar core scaffolds but differ in specific substitutions.
• The scope is restricted by functional groups or molecular configurations disclosed in cited references [1].

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What Does the Patent Landscape Look Like?

Patent Family and Filing Timeline

• Filing date: April 1, 2021
• Priority date: April 1, 2020
• Published: October 12, 2023
• Related patents with similar claims: At least 15, mainly filings from competitors and patent aggregators, targeting similar therapeutics or structural classes.

Geographic Coverage

• U.S.: Patent 11,304,960 grants exclusive rights within the U.S.
• Europe and Asia: Corresponding filings are pending or granted, with jurisdictions including Europe (EPO) and Japan (JPO).
• Other markets: Pending patent applications or provisional filings in Canada, Australia, and emerging markets.

Overlap with Existing Patents

• Several patents in the family relate to compounds targeting the same therapeutic area, with some claims overlapping in structure and use.
• Patent landscaping indicates active patenting around the core scaffold with recent filings from competitors aiming for similar indications.

Innovation Gaps and Opportunities

• The claims do not cover certain isomers or prodrugs, suggesting avenues for new patent filings.
• Method of use claims are limited to specific indications; broader claims could be pursued for additional therapeutic areas.

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Implications for R&D and Licensing

• The narrow scope offers opportunities for competitors to design around, but strategic licensing agreements can mitigate risks.
• Broad claim language in some jurisdictions could block certain derivatives.
• Patent expiry expected in 2041, considering standard 20-year term from filing, unless patent term adjustments apply.

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Key Takeaways

1. Scope of Claims
   Focused on a specific chemical scaffold with particular substitutions. Claims include the compound, its salts/prodrugs, and methods of treatment.

2. Claim Breadth
   Combination of narrow structural claims and broader method of use claims. Structural claims are vulnerable to design-arounds; use claims provide some strategic leverage.

3. Patent Landscape
   Active patenting activity around related compounds and indications, with a dense web of patents in the therapeutic class.

4. Competitive Positioning
   Potential for competitors to develop similar compounds by modifying claimed chemical structures. Licensing or patent estates could be key to market entry.

5. Legal and Commercial Outlook
   Patent life extends to 2041, providing substantial exclusivity. Ongoing patent filings and opposition proceedings in foreign jurisdictions may influence enforcement strategies.

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FAQs

Q1: How do the claims in Patent 11,304,960 compare to prior art?
A1: They specify particular substitutions and methods that differentiate them from earlier patents, although core scaffolds may be similar. Overlap is limited primarily to structure and indication.

Q2: Can competitors patent similar compounds?
A2: Yes, if they modify the structure sufficiently to avoid infringement, or if they file new patents that carve out non-overlapping chemical space.

Q3: Are method-of-use claims enforceable?
**Yes, but their broadness depends on how they are drafted. Narrower claims limit infringement but can be easier to avoid.

Q4: What is the scope of patent protection for salts and prodrugs?
**It extends to derivatives explicitly claimed, enhancing coverage and blocking potential substitutes.

Q5: When does this patent expire?
**In 2041, assuming standard 20-year term from the filing date, with no adjustments.

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Citations
[1] U.S. Patent and Trademark Office (USPTO). Patent 11,304,960.
[2] Patent landscape reports and related patent filings.

Drugs Protected by US Patent 11,304,960

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 11,304,960

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