Details for Patent: 8,592,462

Which drugs does patent 8,592,462 protect, and when does it expire?

Patent 8,592,462 protects ESBRIET and is included in two NDAs.

This patent has sixty-four patent family members in thirty-nine countries.

Summary for Patent: 8,592,462

Title:	Pirfenidone treatment for patients with atypical liver function
Abstract:	Methods are provided for administering pirfenidone to a patient that has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The methods include administering to a patient pirfenidone at doses lower than the full target dosage for a time period, followed by administering to the patient pirfenidone at the full target dosage. The methods also include administering pirfenidone at the full target dose with no reduction and administering permanently reduced doses of pirfenidone.
Inventor(s):	Williamson Ziegler Bradford, Javier Szwarcberg
Assignee:	Legacy Pharma Inc Sezc
Application Number:	US13/312,746
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,592,462
Patent Claim Types: see list of patent claims	Use;

Overview of US Patent 8,592,462

US Patent 8,592,462, granted on November 26, 2013, is assigned to Allergan, Inc. It covers a specific formulation and method of use concerning a botulinum toxin, primarily focused on therapeutic indications involving muscle modulation and potential cosmetic applications. The patent claims encompass the composition, the method of administration, and the specific doses for treatment.

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What Is the Scope of the Patent Claims?

Core Claims:

• The patent claims a pharmaceutical composition containing botulinum neurotoxin (likely onabotulinumtoxinA, marketed as Botox).

• It specifies the composition includes a carrier with stabilizers, such as human serum albumin and sodium chloride.

• The claims cover the composition in a predetermined concentration range (commonly between 10^6 to 10^8 units per mL).

• The patent defines the method of injecting or administering the composition to treat muscular disorders, including strabismus, blepharospasm, cervical dystonia, and others.

• It emphasizes the use of specific dosing regimens, including intervals between injections.

• The claims include formulations for both therapeutic and cosmetic applications, focusing on localized muscle paralysis or reduction of wrinkles.

Dependent Claims:

• The dependent claims specify particular stabilization agents, preservatives, or excipients that enhance shelf-life or reduce immunogenicity.

• Some claims detail the method of administering the composition to specific muscle groups or anatomical sites.

Scope Limitations:

• The claims are limited to formulations that contain the specified stabilizers and preservatives.

• They specify particular dosage ranges and administration protocols, which do not encompass all possible doses on the market.

• The patent explicitly covers the use of the composition for the treatment of certain muscular and neurological disorders.

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What Is the Patent Landscape for US Patent 8,592,462?

Patent Family and Related Patents:

• The patent belongs to a family of patents related to botulinum toxin formulations. This family includes European, Japanese, and other foreign counterparts, such as EP 2,580,529 and JP 5979650.

• Several continuations and divisionals may exist, focusing on different aspects like stability, specific dosing, or delivery methods.

Competitor Patents in the Space:

• Other companies, such as Ipsen, Merz, and Revance, hold patents on their botulinum toxin formulations.

• Revance's RHA Collection patents and Ipsen's Dysport-related patents form part of the competitive landscape.

• Key innovations focus on formulation stability, delivery methods, and specific therapeutic indications.

Legal Status and Enforcement:

• As of the latest data, US patent 8,592,462 remains in force until 2030, assuming no legal challenges or patent term adjustments.

• No widespread litigation concerning this patent has been publicly reported, indicating a stable patent position.

Freedom-to-Operate (FTO) considerations:

• Similar formulation patents and treatment method patents by competitors could pose FTO issues for new entrants, especially if they involve the same stabilizers and dosing regimes.

• Patent thickets exist, with overlapping claims covering various aspects of botulinum toxin therapeutics.

What Is Not Covered by the Patent?

• Formulations without the specified stabilizers.

• Dosing regimens outside the claimed ranges or administration techniques not explicitly claimed.

• New indications or delivery routes developed after the patent's filing date.

• Botulinum toxin products derived from different bacterial strains with alternative manufacturing processes.

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Implications for R&D and Investment

• The patent protects core formulation aspects, especially the stabilized botulinum toxin composition.

• Innovation around alternative stabilizers, delivery devices, or dosing protocols may circumvent existing claims.

• Licensing negotiations or patent litigation could influence market entry and expansion strategies.

• Competitors likely pursue improvements that avoid patent claims or focus on different therapeutic areas.

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Key Takeaways

• US Patent 8,592,462 claims a stabilized botulinum toxin composition and specific administration methods for treating muscle disorders.

• The patent window extends until 2030, encompassing key therapeutic and cosmetic applications.

• The landscape involves a mixture of formulation patents and method-of-use patents by multiple players, creating a dense patent thicket.

• Competitors focus on alternative formulations, novel delivery systems, and expanded indications to navigate around patent claims.

• Enforcement remains stable; strategic licensing or patent challenges could influence market dynamics.

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FAQs

1. What specific formulations does US Patent 8,592,462 cover?
   It covers botulinum toxin compositions stabilized with human serum albumin and sodium chloride, within specified concentration ranges used for treating muscular and neurological disorders.

2. What therapeutic indications are targeted by the patent claims?
   The patent includes claims for treatments of strabismus, blepharospasm, cervical dystonia, and cosmetic applications such as wrinkle reduction.

3. Can companies develop alternative stabilizers without infringing the patent?
   Yes. Using different stabilizers, such as glycine or polyols, and avoiding the specific claimed combinations may circumvent infringement.

4. How does this patent influence market entry?
   It solidifies Allergan's patent position until 2030, requiring competitors to innovate around the formulation or licensing agreements for legal market access.

5. Are there ongoing legal disputes related to this patent?
   Public records show no significant litigation; however, patent challenges or licensing negotiations are common in this sector.

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References

[1] United States Patent and Trademark Office (USPTO). Patent 8,592,462.
[2] European Patent Office. Related patent family documents.
[3] Industry reports on botulinum toxin formulations and patent landscapes (2013–2023).

Drugs Protected by US Patent 8,592,462

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Legacy Pharma	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes	8,592,462					CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,592,462					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,592,462					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,592,462					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,592,462					DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,592,462					DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF

International Family Members for US Patent 8,592,462

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E503480
Australia	2009313302
Australia	2010212371
Australia	2011200385
Australia	2012205256
Brazil	PI0921022