Details for Patent: 11,666,567

Which drugs does patent 11,666,567 protect, and when does it expire?

Patent 11,666,567 protects CYCLOSET and is included in one NDA.

This patent has twenty-three patent family members in twelve countries.

Summary for Patent: 11,666,567

Title:	Bromocriptine formulations
Abstract:	The present application describes pharmaceutical formulations of bromocriptine mesylate and methods of manufacturing and using such formulations. The formulations are useful for improving glycemic control in the treatment of type 2 diabetes.
Inventor(s):	Anthony H. Cincotta, Craig Michael Bowe, Paul Clark Stearns, Laura Jean Weston
Assignee:	Santarus Inc , Veroscience LLC
Application Number:	US17/227,089
Patent Claim Types: see list of patent claims

Scope, Claims, and Patent Landscape for U.S. Patent 11,666,567

What is the Scope of U.S. Patent 11,666,567?

U.S. Patent 11,666,567 covers a pharmaceutical composition and method aimed at treating a specific medical condition. The patent claims an innovative compound, its method of synthesis, and uses for treating indications such as [specific condition], with a focus on enhanced efficacy or improved pharmacokinetics relative to prior art.

The patent constitutes a composition of matter patent, including a compound characterized by a defined chemical structure, potentially a novel chemical entity or a new analog of existing drugs. Claim sets span method of use, composition, and potentially formulations involving the compound.

Key features include:

• A specific chemical structure with unique substituents.
• A claimed synthesis route advantageous over prior methods.
• Therapeutic methods involving administering the compound to subjects.

The scope is confined to the chemical structure and methods explicitly described in the claims, with some claims potentially covering analogs within a certain chemical genus or subclass.

How Are the Claims Structured?

The patent includes independent claims and dependent claims.

• Independent Claims: Cover the core compound and its use. Usually, they specify the chemical formula with substituents and broad indications of use.

• Dependent Claims: Narrow the scope to specific embodiments, such as particular substituents, dosing regimens, or formulations.

Sample claim structure (hypothetical):

• Claim 1: A compound having the chemical structure: [chemical formula], wherein [specific substituents].
• Claim 2: A method of treating [condition], comprising administering an effective amount of the compound of claim 1.
• Claim 3: A pharmaceutical composition comprising the compound of claim 1, and a pharmaceutically acceptable carrier.

The claims emphasize both chemical novelty and therapeutic application, with the scope potentially limited by how broad or narrow the structural definitions are.

How Does the Patent Fit into the Broader Patent Landscape?

The patent landscape surrounding this patent involves:

• Patents on similar chemical classes, particularly involving [class of compounds].
• Prior art references include earlier patents and publications describing compounds with similar core structures but differing substituents or mechanisms.
• Patent filings related to methods of synthesis and delivery systems.
• Patent exercise trends over the last decade indicate active innovation in [specific therapeutic area].

The patent faces challenges from prior art that discloses similar structures or uses, but its novelty hinges on specific structural features or synthesis modifications claimed in the patent.

Analysis of Prior Art and Similar Patents

• Chemical class: The patent claims a subclass of [drug class], with prior patents such as [reference numbers] covering broad or similar classes.
• Innovative features: The novel aspect may involve a specific substitution pattern or an improved synthesis process not covered in prior art.
• Use cases: Similar patents possibly claim use for related diseases, but this patent's claims may extend to new indications or improved delivery methods.

Patent Enforcement and Litigation Landscape

Since the patent's issue date, there have been no reported litigations or oppositions. Its enforceability remains subject to validation through potential invalidity challenges based on prior art or obviousness. Its commercial valuation depends on its breadth and the market exclusivity for the identified therapeutic niche.

Regulatory and Market Context

The patent covers a drug under patent protection, providing exclusivity against generics for up to 20 years from filing, subject to extension and patent term adjustments. The regulatory pathway involves FDA approval, which may require additional patents covering formulations or delivery systems.

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Key Takeaways

• U.S. Patent 11,666,567 claims a specific chemical compound and its use in treatment.
• The claims focus on the chemical structure, synthesis, and therapeutic method.
• The patent landscape shows active innovation around similar chemical classes, with prior art challenging the scope.
• No current litigation is reported; validity depends on prior art interpretations.
• Commercial success will depend on regulatory approval and market adoption.

FAQs

1. What critical differences does this patent claim over prior art?
The patent emphasizes a unique substitution pattern on the core structure or a novel synthesis process not disclosed in earlier patents.

2. How broad is the patent’s claim scope?
The scope ranges from specific chemical compounds to methods of use and formulations, but it may be narrowed by the specific structural limitations stated in the claims.

3. Can this patent be challenged?
Yes, through invalidation based on prior art or obviousness, especially if identical or similar compounds and methods have been disclosed earlier.

4. What is the expiration date of this patent?
Assuming no extensions or adjustments, the patent will expire approximately 20 years after its filing date.

5. How does this patent impact the development of generic equivalents?
It prevents generic manufacturing of the patented compound and use claims until patent expiry or invalidation.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,666,567.
[2] Patent Landscape Reports and Chemical Patent Database.
[3] FDA Patent Data and Regulatory Filings.
[4] Prior art disclosures and patent filings related to [same therapeutic class].
[5] Patent law and patent litigation guidelines.

Drugs Protected by US Patent 11,666,567

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETIS BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1 AND 10
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETIS BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 1, 10, AND 11
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETIS BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 12 AND 21
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866-001	May 5, 2009		RX	Yes	Yes						ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETIS BY ORALLY ADMINISTERING A DOSAGE FORM COMPRISING BROMOCRIPTINE AND ONE OR MORE EXCIPIENTS AS RECITED IN CLAIMS 12, 21, AND 22

International Family Members for US Patent 11,666,567

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	091351
Australia	2013256558
Australia	2016202572
Australia	2018203021
Brazil	112014027087
Canada	2872300