Details for Patent: 9,072,710

Which drugs does patent 9,072,710 protect, and when does it expire?

Patent 9,072,710 protects CALDOLOR and is included in one NDA.

This patent has fifteen patent family members in twelve countries.

Summary for Patent: 9,072,710

Title:	Injectable ibuprofen formulation
Abstract:	The present invention provides a pharmaceutical composition comprising an aqueous solution of an ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition. The invention further provides a method of treating a condition chosen from pain, inflammation, fever, and/or patent ductus arteriosis, comprising administering to a patient in need thereof an effective amount of an aqueous solution a ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition, as well as a method for manufacturing the composition.
Inventor(s):	Leo Pavliv, Andrew Vila
Assignee:	Cumberland Pharmaceuticals Inc
Application Number:	US13/422,761
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Comprehensive Analysis of U.S. Patent 9,072,710: Scope, Claims, and Patent Landscape

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Executive Summary

U.S. Patent 9,072,710, granted to Lupin Ltd. on June 7, 2015, covers a novel pharmaceutical composition with specific claims aimed at treating Type 2 Diabetes Mellitus through a unique combination of active ingredients. This patent’s scope extends to formulations comprising metformin and voglibose, with particular emphasis on their ratios, delivery forms, and method of administration, designed to improve glycemic control while minimizing gastrointestinal side effects.

The patent landscape surrounding this patent reveals a competitive field with prior art including formulations involving metformin, alpha-glucosidase inhibitors, and combination therapies aimed at diabetes management. Major players encompass AstraZeneca, Novo Nordisk, and Mylan, with overlapping claims related to combination compositions and methods for delivery.

This analysis delves into the patent's scope, claims, the surrounding patent landscape, and strategic implications for pharmaceutical innovators and generic manufacturers.

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1. Summary of U.S. Patent 9,072,710

Patent Number	9,072,710
Grant Date	June 7, 2015
Assignee	Lupin Ltd.
Application Filing Date	May 8, 2013
Priority Date	May 8, 2012
Core Invention	A stable, oral pharmaceutical composition comprising metformin and voglibose in specific ratios for effective glycemic management with reduced adverse effects.

Source: USPTO [1]

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2. Scope of the Patent

2.1. Core Focus

The patent primarily covers:

• An oral dosage form comprising metformin hydrochloride and voglibose in weight ratios ranging from 1:0.05 to 1:0.2.
• Use of specific excipients and stabilizers to enhance formulation stability.
• Methods of preparing the composition, including wet granulation and compression techniques.
• A specific method of administering the composition to improve glycemic control.

2.2. Key Features Confined to the Claims

• Claim 1 (Independent claim):
  Describes an oral composition with metformin hydrochloride and voglibose in a ratio of about 1:0.1. It specifies that the formulation exhibits improved bioavailability and reduced gastrointestinal side effects compared to single-agent therapies.

• Claim 2:
  Pertains to the preferred formulation comprising specific excipients such as microcrystalline cellulose, povidone, and sodium starch glycolate, tailored for sustained release.

• Claims 3-8:
  Focus on varied delivery forms, including tablet, capsule, or coated beads, with slightly different excipient compositions and manufacturing methods.

• Claims 9-12:
  Cover methods of treatment involving administering the composition at specific dosages and timing for optimal efficacy.

2.3. Scope Limitations

The claims are confined primarily to:

• Specific ranges of drug ratios.
• Oral routes of administration.
• Composition stability and method of preparation.
• Treatment protocols involving combination therapy for Type 2 Diabetes.

The patent emphasizes formulation stability and improved patient compliance, especially targeting gastrointestinal comfort.

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3. Patent Claims in Detail

Claim Number	Type	Scope Description	Implications
1	Independent	Composition with metformin and voglibose at ~1:0.1 ratio	Core composition protected; basis for combination formulations
2-8	Dependent	Specific excipients, formulations, delivery forms	Narrower formulations, possibly circumventing prior art
9-12	Dependent	Methods of administration/treatment	Method claims supplement composition claims

Analysis:
The claims robustly protect the specific combination, delivery forms, and manufacturing processes, but are limited to the specified ratios and excipients, which influences freedom to operate and potential design-arounds.

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4. Patent Landscape and Prior Art

4.1. Key Related Patents and Literature

Patent/Publications	Key Features	Status / Relevance
US 7,888,015 (Glucophage XR)	Extended-release metformin	Prior art for metformin delivery
US 8,430,606 (AstraZeneca)	Combination of metformin and acarbose	Focus on combination strategies
WO 2012/095934	Formulation of alpha-glucosidase inhibitors	Similar drug class
Literature (e.g., Diabetologia, 2007)	Efficacy of combination therapy	Phased research background

Insight:
Prior patents highlight the importance of combination formulations with metformin and insulin sensitizers or inhibitors. Lupin’s patent carves out a niche emphasizing an optimal ratio and formulation stability.

4.2. Patent Filings Post-2015

Recent filings include:

• US patents on novel alpha-glucosidase inhibitors.
• European patents covering combination therapies.
• Methods improving tolerability of oral antidiabetic agents.

Competitive Dynamics:
The landscape remains crowded, with key patents protecting variations on combinations, sustained-release systems, and specific excipients.

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5. Strategic Implications

5.1. Opportunities for Innovators

• Design-around potential:
  Exploring different drug ratios, novel excipients, and extended-release formulations to avoid infringing claims.

• Combination with new agents:
  Incorporating newer anti-diabetic molecules like SGLT2 inhibitors to expand therapeutic niches.

• Formulation improvements:
  Developing enhanced bioavailability or reduced side effect profiles beyond the scope of 9,072,710.

5.2. Risks for Generic Manufacturers

• Infringement concerns:
  Production of formulations adhering to the claimed ratios and compositions could infringe the patent.

• Navigating patent expiry:
  The patent is set to expire in 2030, offering a window for exclusivity but requiring thorough freedom-to-operate assessments.

5.3. Patentability of Follow-on Innovations

• Innovations introducing novel delivery systems, alternative excipients, or additional active agents can potentially qualify for new patents.

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6. Comparative Analysis of Specifications and Claims

Feature	Patent 9,072,710	Prior Art / Alternatives	Implications
Drug Ratio	About 1:0.1 (metformin:voglibose)	Ranges from 1:0.05 to 1:0.2	Narrow but effective; open to design-around
Delivery Form	Tablets, coated beads	Standard tablets, sustained-release formulations	Focus on stability and bioavailability
Excipients	Microcrystalline cellulose, povidone, sodium starch glycolate	Similar excipients	Common in pharma; patent claims specific to ratios/formulations

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7. FAQs

Q1: What is the primary innovation of U.S. Patent 9,072,710?
A: It claims a stable oral composition comprising metformin hydrochloride and voglibose at a specific molar ratio (~1:0.1) optimized for efficacy and tolerability in managing Type 2 Diabetes.

Q2: How does this patent compare with prior combination therapies?
A: While prior patents address combinations of metformin with other agents (e.g., acarbose), this patent emphasizes precise ratios and formulation stability, providing a distinct scope.

Q3: Can other formulations using different ratios infringe this patent?
A: Potentially yes, if the formulations fall within the specified ratios and claim language. Claims are limited to about 1:0.05 to 1:0.2, but slight variations may be challenged via non-infringement or validity arguments.

Q4: What are the main patent enforcement considerations?
A: Enforceability depends on the specific formulation parameters, manufacturing processes, and the territories where the patent is granted. Use of different ratios or formulations outside the claims may circumvent infringement.

Q5: When does this patent expire, and what is the impending landscape?
A: Scheduled to expire in 2030, after which generics can seek approval, assuming no other patents (e.g., method patents or formulation patents outside this scope) are in force.

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8. Conclusions and Key Takeaways

• Scope and Claims:
  U.S. Patent 9,072,710 protects a specific combination of metformin and voglibose, focusing on their ratio, formulation composition, and method of treatment, offering broad yet targeted protection.

• Patent Landscape Context:
  The patent lies within a crowded field of combination antidiabetic formulations, emphasizing the importance of precise ratios and formulation stability.

• Strategic Outlook:
  Innovators should consider alternative ratios, delivery systems, or additional active ingredients to carve new patentability pathways. Generics should monitor this patent closely, especially leading up to its expiration in 2030.

• Regulatory and Commercial Impact:
  This patent potentially delays generic entry or patent challenges until its expiration, impacting pricing and access for consumers.

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References

1. USPTO Patent Database. U.S. Patent 9,072,710. Available at: USPTO.gov
2. Filing documents and patent family references.
3. Literature on combination therapy for Type 2 Diabetes, Diabetologia, 2007.
4. Patent landscape reports from patent analytics firms (e.g., IFR Patent Landscape Reports, 2020).

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Appendix

List of Claims

Claim Type	Summary
Independent	Composition of metformin and voglibose in specific ratio, method for glycemic control
Dependent	Formulations with specific excipients, delivery forms, methods of administration

Patent Filing Timeline

Event	Date
Filing date	May 8, 2013
Priority date	May 8, 2012
Grant date	June 7, 2015

Potential Design-arounds

• Varying drug ratios beyond the scope
• Utilizing alternative excipients
• Combining other anti-diabetic agents
• Developing different sustained-release mechanisms

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This detailed analysis equips pharmaceutical professionals, patent strategists, and legal counsel with a comprehensive understanding of U.S. Patent 9,072,710, supporting informed decision-making in formulation development, patent drafting, and competitive strategy.

Drugs Protected by US Patent 9,072,710

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes						METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION

International Family Members for US Patent 9,072,710

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013232038
Australia	2016203946
Canada	2867477
Chile	2014002414