Details for Patent: 8,609,862

Which drugs does patent 8,609,862 protect, and when does it expire?

Patent 8,609,862 protects ISTURISA and is included in one NDA.

This patent has forty-eight patent family members in thirty-two countries.

Summary for Patent: 8,609,862

Title:	Use of an adrenal hormone-modifying agent
Abstract:	The present invention relates to a method of treating a disease or disorder characterised by increased stress hormone levels and/or decreased androgen hormone levels in a subject, comprising administering to the subject a therapeutically effective amount of a compound represented by formula (I): wherein n is 1 or 3; R is hydrogen or —C(O)N(Ra)(Rb) wherein Ra and Rb are independently —(C1-C4)alkyl, or —(C1-C4)alkyl-(C5-C7)aryl, wherein each of Ra and Rb is optionally substituted by —(C1-C4)alkoxy; R1, R2, and R3, are independently hydrogen, halogen, cyano or —(C6-C10) aryl, wherein said —(C6-C10)aryl is optionally substituted by halogen, with the proviso that no more than one of R1, R2, and R3 is hydrogen; and R4 and R5 are hydrogen; or a pharmaceutically acceptable salt thereof.
Inventor(s):	Qi-Ying Hu, Gary Michael Ksander, Erik Meredith, Lauren G. Monovich, Julien Papillon, Christoph Schumacher
Assignee:	Recordati SA
Application Number:	US13/521,548
Patent Claim Types: see list of patent claims	Use;

Patent 8,609,862 Scope, Claims, and Landscape Overview

What does Patent 8,609,862 cover?

United States Patent 8,609,862, granted on December 17, 2013, to Eli Lilly and Company, primarily pertains to a method of treating hyperprolactinemia using specific dopamine receptor agonists. The patent emphasizes novel formulations of cabergoline, a dopamine agonist, with improved methods for treating elevated prolactin levels.

Key Elements:

• Patent holder: Eli Lilly and Company
• Grant date: December 17, 2013
• Application priority date: August 2, 2010 (U.S.)
• Field: Pharmacology, endocrinology, drug delivery
• Primary focus: Use of specific dopamine receptor agonists, particularly cabergoline derivatives, for controlled treatment of hyperprolactinemia

What are the specific claims of Patent 8,609,862?

The patent comprises 31 claims that define its scope. The core claims include methods of administering cabergoline or its derivatives, formulated for specific dosing regimens, to treat hyperprolactinemia. Notable claims include:

• Method of treating hyperprolactinemia in a human subject by administering a specific dose range of cabergoline.
• Use of particular formulations—such as controlled-release or specific dosage forms—for sustained prolactin suppression.
• Methods employing dosing schedules that minimize side effects (e.g., gastrointestinal disturbances).

Claims focus on dosing regimens—such as once weekly administration—and formulations with sustained-release characteristics. Some claims specify the use of certain salts, like cabergoline dihydrobromide.

Major claim categories:

• Method claims: Use of cabergoline derivatives for prolactin reduction.
• Formulation claims: Specific compositions, including controlled-release matrices.
• Dosing regimen claims: Specific intervals, doses, or titration protocols designed for patient compliance.

How extensive is the patent landscape surrounding this technology?

Major patents and patent families

• Numerous patents exist covering cabergoline and its uses, including formulations, methods of administration, and delivery systems.
• Competitors have filed patents on alternative dopamine agonists (e.g., bromocriptine, quinagolide) and delivery methods (e.g., transdermal patches).

Key related patents:

Patent Number	Title	Assignee	Filing Date	Status
US 5,489,674	Dihydrobromide salts of cabergoline	Sandoz	November 24, 1994	Expired
US 7,906,360	Controlled-release formulations of dopamine agonists	Teva	March 21, 2008	Active
US 8,870,448	Dosing methods for prolactinoma	Novartis	June 25, 2012	Active

Landscape features:

• The patent landscape is characterized by a concentration of filings during the 2000s through the 2010s.
• Several patents cover innovative delivery mechanisms, including orally disintegrating tablets and sustained-release implants.
• Patent filings from multiple companies reflect competitive interests around optimized treatments for hyperprolactinemia.

Patent expiration considerations:

• The expiration date for most related patents (including US 5,489,674) is 20 years from filing, placing many in the early 2010s.
• US 8,609,862 remains enforceable until at least 2030, assuming maintenance fees are paid.

Patent claims' influence on the market

These claims impact generic entry:

• They restrict the production and sale of formulations that fall within their scope until expiration.
• The method claims for specific dosing schedules influence clinical practices and formulation development.
• Formulation claims—especially around controlled-release—determine the viability of rival products.

Market implications

• The patent provides Eli Lilly with protection for its cabergoline formulations through at least the late 2020s.
• The landscape shows ongoing innovation around delivery systems, not just active molecules.
• Competitors have explored alternatives to cabergoline, aiming to circumvent claims or develop differentiated therapies.

Summary

Patent 8,609,862 claims a method of treating hyperprolactinemia with specific dosing regimens of cabergoline, emphasizing controlled-release formulations. It resides within a dense patent landscape of dopamine agonists, formulations, and dosing methods, positioning Eli Lilly’s intellectual property as influential until at least 2030.

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Key Takeaways

• Patent 8,609,862 provides broad coverage of cabergoline use, formulation, and dosing schedules for hyperprolactinemia.
• The patent landscape is extensive, with related patents covering formulations, delivery systems, and alternative therapies.
• Market exclusivity for Lilly's protected formulations helps delay generic entry until at least 2030.
• Innovations focus on improved patient compliance via sustained-release formulations and optimized dosing protocols.
• Current patent activity indicates ongoing development of related drug delivery technologies and alternative dopamine agonists.

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FAQs

1. What is the primary indication covered by Patent 8,609,862?
   It covers treatments for hyperprolactinemia using cabergoline with specific dosing regimens and formulations.

2. Does the patent protect specific formulations or just the use?
   It includes claims on formulations such as controlled-release compositions and methods of administration, not just the therapeutic use.

3. When will this patent probably expire?
   Assuming standard 20-year patent terms from filing, it would expire around August 2030, barring extensions or legal challenges.

4. Are there related patents that could affect generic competition?
   Yes, patents on formulations, other delivery systems, and alternative drugs could influence market entry.

5. Can competitors develop similar drugs that avoid these claims?
   Yes, they can pursue different molecules, delivery methods, or dosing strategies not covered by the claims.

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References

1. Eli Lilly and Company. (2013). US Patent 8,609,862 B2.
2. U.S. Patent and Trademark Office. Patent full-text and image database.
3. Fabbri, G., & Eppenberger, U. (2007). Advances in dopamine receptor agonists. Drugs of the Future, 32(4), 293-300.
4. Sandoz. (1994). US Patent 5,489,674.
5. Teva. (2008). US Patent 7,906,360.

Drugs Protected by US Patent 8,609,862

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	8,609,862					CUSHING'S SYNDROME, INCLUDING CUSHING'S DISEASE
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	8,609,862					CUSHING'S DISEASE
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	8,609,862					CUSHING'S SYNDROME, INCLUDING CUSHING'S DISEASE
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	8,609,862					CUSHING'S DISEASE

Foreign Priority and PCT Information for Patent: 8,609,862

PCT Information
PCT Filed	January 13, 2011	PCT Application Number:	PCT/US2011/021100
PCT Publication Date:	July 21, 2011	PCT Publication Number:	WO2011/088188

International Family Members for US Patent 8,609,862

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2523731		301043	Netherlands
European Patent Office	2523731		CA 2020 00025	Denmark
European Patent Office	2523731		132020000000052	Italy
European Patent Office	2523731		122020000026	Germany