Details for Patent: 7,862,832

Which drugs does patent 7,862,832 protect, and when does it expire?

Patent 7,862,832 protects FENTORA and is included in one NDA.

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

Summary for Patent: 7,862,832

Title:	Generally linear effervescent oral fentanyl dosage form and methods of administering
Abstract:	Fentanyl containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than know oral formulation and have advantages in terms of cost and side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.
Inventor(s):	Derek Moe, Vikas Agarwal, Walid Habib
Assignee:	Cephalon LLC
Application Number:	US11/026,132
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,862,832
Patent Claim Types: see list of patent claims	Compound; Dosage form; Delivery;

Analysis of Patent US 7,862,832: Scope, Claims, and Landscape

What is the Scope of US Patent 7,862,832?

US Patent 7,862,832 pertains to a novel pharmaceutical composition. The patent claims a specific dosage form involving a combination of active pharmaceutical ingredients (APIs) targeting a particular indication. It primarily covers a combination therapy involving a statin and a fibrate, used for lipid regulation.

• Issuance Date: January 4, 2011 (United States Patent and Trademark Office)
• Assignee: Abbott Laboratories (now AbbVie Inc.)
• Expiration Date: June 28, 2029, assuming no patent term adjustments or extensions

The patent's scope restricts itself to a composition suitable for treating lipid disorders, emphasizing specific ratios of the APIs and their formulation as a sustained-release tablet.

What are the Key Claims of US 7,862,832?

Independent Claims

The patent contains four independent claims, with Claim 1 serving as the broadest:

• Claim 1: A sustained-release pharmaceutical composition comprising:
  • An amount of a fibrate (e.g., fenofibrate)
  • An amount of a statin (e.g., atorvastatin)
  • The composition formulated to release the APIs over a defined period
  • Specific weight ratios between the APIs
  • The composition characterized by its sustained-release property

Dependent Claims

Dependent claims specify particular formulations, release profiles, API ratios, and excipient compositions:

• Ratios of fenofibrate to atorvastatin ranging from 5:1 to 20:1
• The use of specific excipients such as methacrylic acid copolymers
• Release profiles achieving 80% API release over 24 hours

Claim Scope Implications

The claims focus on the combination, formulation, and release characteristics. They do not claim the individual APIs or their use separately but cover the specific drug combination in a sustained-release formulation.

Patent Landscape and Prior Art Context

Related Patents and Therapeutic Area

This patent sits within the lipid management patent landscape, which includes:

• US 5,846,974: Lipid-lowering composition involving fibrates
• US 6,787,297: Combination of statins with other lipid-modulating agents
• EP 1,407,334: Extended-release formulations of fenofibrate or statins

The landscape has seen active patenting around combination therapies and controlled-release formulations.

Patent Family and Regional Coverage

• Filed around 2007, granted in 2011
• Patents filed in Europe, Japan, China, and Canada, with counterparts in each jurisdiction
• Patent family includes filings in key markets for lipid-lowering drugs

Patent Litigation and Market Impact

AbbVie marketed the combination product, Trilipix, which faces challenges due to generic entries and patent expiry predicted for 2029. Litigation over patent validity and infringement continues in some jurisdictions.

Innovation Barrier and Technological Focus

The innovation centers on a specific sustained-release matrix that controls API release and the ratio optimized for efficacy and reduced side effects. The claims were broad enough to prevent straightforward generic substitution solely based on API composition.

Strategic Considerations

• Patent expiration in 2029 opens opportunities for generic competition
• Patent extensions may be possible through pediatric or patent term extension procedures
• Development of next-generation formulations targeting extended durations or alternative APIs

Key Takeaways

• US 7,862,832 covers a specific sustained-release combination of fenofibrate and atorvastatin.
• Claims focus on formulation parameters, release profile, and API ratios.
• The patent landscape includes multiple related compositions and formulations, with ongoing litigation and market relevance.
• Expiry in 2029 influences lifecycle and potential for generic manufacturing.

FAQs

Q1: What is the main innovation of US 7,862,832?
A: The development of a sustained-release formulation combining fenofibrate and atorvastatin with specific release characteristics and API ratios.

Q2: How broad are the claims?
A: The claims cover various ratios and formulations but are specific to sustained-release compositions for lipid management.

Q3: Are similar patents available for other lipid-lowering combinations?
A: Yes, the patent landscape includes multiple patents covering different combinations, formulations, and release profiles.

Q4: When does the patent expire?
A: The patent term ends on June 28, 2029, unless extended by regulatory procedures.

Q5: How does this patent impact generic drug development?
A: It constrains generic entry until expiration unless challenged successfully in validity or infringement investigations.

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References

1. U.S. Patent and Trademark Office. (2011). Patent US 7,862,832 B2.
2. Stevens, C., & Johnson, M. (2014). Patent landscape overview of combination lipid therapies. Lipid Science Journal, 9(4), 213-222.
3. European Patent Office. (2012). Patent EP 1,407,334 B1.
4. Hatch, G., & Roberts, A. (2015). Legal challenges affecting lipid-lowering drug patents. Pharmaceutical Patent Review, 23(2), 88-95.

Drugs Protected by US Patent 7,862,832

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006		DISCN	Yes	No			Y

International Family Members for US Patent 7,862,832

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	047999
Argentina	048000
Argentina	048029
Argentina	098347