Details for Patent: 8,052,993

Which drugs does patent 8,052,993 protect, and when does it expire?

Patent 8,052,993 protects PROMACTA and is included in one NDA.

Protection for PROMACTA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has eighty-one patent family members in thirty-six countries.

Summary for Patent: 8,052,993

Title:	3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Abstract:	Disclosed are novel pharmaceutical compositions containing 3'-[(2Z)-[1-(3,4-dimethylphenyl) -1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1- ,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) (eltrombopag olamine) and processes for preparing the same.
Inventor(s):	Muller; Francis X (King of Prussia, PA), Kapsi; Shivakumar G (King of Prussia, PA)
Assignee:	GlaxoSmithKline LLC (Philadelphia, PA)
Application Number:	12/607,291
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,052,993
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Process; Use;

Understanding the Scope and Claims of United States Patent 8,052,993

Introduction

United States Patent 8,052,993 is a significant patent in the pharmaceutical industry, particularly related to the drug eltrombopag, which is marketed under the brand name Promacta. This patent is crucial for understanding the intellectual property landscape surrounding this medication.

Patent Overview

Patent Number and Expiration Date:

• The patent number is 8,052,993, and it is set to expire on August 1, 2027[2][4].

Type of Protection:

• This patent provides protection for the composition of matter and use of eltrombopag, a thrombopoietin receptor agonist used to treat thrombocytopenia or aplastic anemia associated with various etiologies[2][4].

Claims and Scope

Composition of Matter:

• The patent claims cover the specific chemical formulation of eltrombopag, including its structure and synthesis. This ensures that the patent holder, GlaxoSmithKline LLC, has exclusive rights to the proprietary chemical formulation of the drug[2][4].

Use Claims:

• The patent also includes claims related to the use of eltrombopag for specific medical conditions. This encompasses the therapeutic applications of the drug, such as treating thrombocytopenia or aplastic anemia[2][4].

Patent Scope Metrics

Independent Claim Length and Count:

• The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. For instance, longer independent claims and a higher count of independent claims can indicate a broader patent scope[3].

Pediatric Extension

• The patent 8,052,993 has been granted a pediatric extension, which extends the patent term by six months. This extension is based on the completion of pediatric studies as required by the FDA. The extended expiration date due to this pediatric extension is February 1, 2028[2][4].

International Jurisdiction

• While the primary focus is on the U.S. patent, it is important to note that similar patents may exist in other jurisdictions with corresponding expiration dates. For example, European and Japanese patents related to eltrombopag may have different expiration dates but generally align with the U.S. patent timeline[1][2].

Impact on Generic Availability

• The expiration of this patent will have significant implications for the availability of generic versions of Promacta. Currently, there is no therapeutically equivalent generic version of Promacta available in the United States due to the active patent protection[2].

Financial and Market Implications

• The patent protection for eltrombopag is a critical factor in the financial performance of GlaxoSmithKline LLC. The exclusive rights granted by the patent ensure that the company can maintain market dominance and revenue from the sale of Promacta until the patent expires.

Litigation and Licensing

• Patents like 8,052,993 can be subject to litigation and licensing agreements. The breadth and clarity of the patent claims can influence the likelihood of patent infringement disputes and the costs associated with licensing and litigation[3].

Conclusion

United States Patent 8,052,993 is a pivotal patent in the pharmaceutical industry, particularly for GlaxoSmithKline LLC and the drug Promacta. Understanding its scope, claims, and expiration date is essential for both the company and potential competitors.

Key Takeaways

• Patent Number and Expiration Date: 8,052,993, expiring on August 1, 2027.
• Type of Protection: Composition of matter and use claims for eltrombopag.
• Pediatric Extension: Extends the patent term to February 1, 2028.
• Impact on Generic Availability: No generic version available until patent expiration.
• Financial and Market Implications: Significant revenue impact for GlaxoSmithKline LLC.
• Litigation and Licensing: Potential for disputes and licensing costs based on patent scope.

FAQs

Q: What is the primary drug protected by United States Patent 8,052,993? A: The primary drug protected is eltrombopag, marketed under the brand name Promacta.

Q: What is the expiration date of United States Patent 8,052,993? A: The patent is set to expire on August 1, 2027, with a pediatric extension to February 1, 2028.

Q: What type of protection does this patent provide? A: The patent provides protection for the composition of matter and use of eltrombopag.

Q: Why is there no generic version of Promacta available? A: The absence of a generic version is due to the active patent protection provided by patents like 8,052,993.

Q: How does the pediatric extension affect the patent term? A: The pediatric extension adds six months to the original patent term, extending it to February 1, 2028.

Sources

1. Ligand Pharmaceuticals Inc. Form 10-K.
2. Drugs.com - Generic Promacta Availability.
3. Hoover Institution - Patent Claims and Patent Scope.
4. DrugBank - Eltrombopag: Uses, Interactions, Mechanism of Action.

Drugs Protected by US Patent 8,052,993

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	AB	RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	AB	RX	Yes	Yes					Y

International Family Members for US Patent 8,052,993

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	059656
Argentina	107711
Australia	2007352608
Australia	2012201288