Details for Patent: 7,547,719

Which drugs does patent 7,547,719 protect, and when does it expire?

Patent 7,547,719 protects PROMACTA KIT and PROMACTA and is included in two NDAs.

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

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

Summary for Patent: 7,547,719

Title:	3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine)
Abstract:	An improved thrombopoietin mimetic, the bis-(monoethanolamine) salt of 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.
Inventor(s):	Moore; Stephen (Tonbridge, GB)
Assignee:	SmithKline Beecham Corp. (Philadelphia, PA)
Application Number:	10/515,304
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,547,719
Patent Claim Types: see list of patent claims	Compound; Composition; Use; Delivery; Process;

United States Patent 7,547,719: A Detailed Analysis

Overview of the Patent

United States Patent 7,547,719, titled "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)," is a crucial patent protecting the active ingredient of the drug Promacta (eltrombopag). Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.

Patent Description

This patent describes a specific chemical compound, eltrombopag, which is used as a thrombopoietin receptor agonist. Eltrombopag is designed to enhance platelet production and is used in the treatment of various types of thrombocytopenia and aplastic anemia[1][3][4].

Claims of the Patent

The patent claims cover the chemical structure of eltrombopag, its synthesis, and its use as a therapeutic agent. Here are some key aspects of the claims:

• Chemical Structure: The patent specifies the detailed chemical structure of eltrombopag, including its stereochemistry and functional groups[4].
• Synthesis: The patent describes methods for synthesizing the compound, which is essential for manufacturing the drug.
• Therapeutic Use: The claims include the use of eltrombopag as an agonist of the thrombopoietin receptor, particularly in enhancing platelet production.

Patent Expiration Date

The patent is set to expire on January 13, 2026, with an additional six months of pediatric exclusivity, extending the protection until July 13, 2026[2][3][5].

Patent Landscape

The patent landscape surrounding Promacta is complex, with multiple patents protecting various aspects of the drug.

• Multiple Patents: There are several patents associated with Promacta, including US7547719, US8052993, US8052994, US8062665, and US8071129, among others. These patents cover different aspects such as the chemical compound, its formulation, and specific uses[2][3].
• Expired Patents: Some patents related to Promacta have already expired, such as US7160870 and US7473686, which were related to thrombopoietin mimetics[3].
• International Protection: Promacta is protected by patents in multiple countries, not just the United States. Understanding the global patent landscape is crucial for strategizing market entry and generic launches[3].

Legal Activities and Exclusivity

• Patent Maintenance: The patent holders have been maintaining these patents through regular fee payments and other legal activities. For example, maintenance fees were paid for US7790704 and US7547719 in recent years[3].
• Exclusivity Periods: Besides patent protection, Promacta also benefits from exclusivity periods granted by the FDA, such as orphan drug exclusivity and pediatric exclusivity. These periods can run concurrently with patent protection and further delay the entry of generic versions[3][5].

Impact on Generic Launch

The expiration of the '719 patent in January 2026 is a significant milestone for potential generic manufacturers. However, the additional six months of pediatric exclusivity and other ongoing patent protections will delay the launch of generic versions until at least July 2026. Any generic manufacturer must ensure that their product does not infringe on the remaining patents and must comply with FDA regulations, including demonstrating bioequivalence and therapeutic equivalence to the reference listed drug (RLD)[2][3][5].

Key Takeaways

• Patent Expiration: The '719 patent expires on January 13, 2026, with an additional six months of pediatric exclusivity.
• Patent Claims: The patent covers the chemical structure, synthesis, and therapeutic use of eltrombopag.
• Patent Landscape: Multiple patents protect Promacta, with some already expired and others set to expire in the near future.
• Legal Activities: Regular maintenance fees and other legal activities are crucial for maintaining patent protection.
• Generic Launch: The launch of generic versions will be delayed until after the expiration of all relevant patents and exclusivity periods.

FAQs

1. What is the primary use of the drug protected by US Patent 7,547,719?

   • The drug, eltrombopag, is used to treat thrombocytopenia and aplastic anemia by enhancing platelet production.

2. When is the '719 patent set to expire?

   • The '719 patent is set to expire on January 13, 2026, with an additional six months of pediatric exclusivity.

3. Are there other patents protecting Promacta?

   • Yes, there are multiple patents protecting various aspects of Promacta, including its formulation and specific uses.

4. What is the significance of pediatric exclusivity in this context?

   • Pediatric exclusivity adds an additional six months to the patent protection period, delaying the potential launch of generic versions.

5. Can generic manufacturers launch their products immediately after the '719 patent expires?

   • No, generic manufacturers must ensure their products do not infringe on other remaining patents and must comply with FDA regulations, including demonstrating bioequivalence and therapeutic equivalence.

Sources

1. DrugBank: Eltrombopag: Uses, Interactions, Mechanism of Action.
2. Drugs.com: Generic Promacta Availability.
3. Pharsight: Promacta Kit patent expiration.
4. Google Patents: US7547719B2 - 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine).
5. FDA: ANDA 216620 - accessdata.fda.gov.

Drugs Protected by US Patent 7,547,719

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 KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-002	Sep 27, 2018	AB	RX	Yes	No					Y
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027-001	Aug 24, 2015	AB	RX	Yes	Yes					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-004	Oct 20, 2011		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-001	Nov 20, 2008		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008		RX	Yes	No					Y
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 7,547,719

PCT Information
PCT Filed	May 21, 2003	PCT Application Number:	PCT/US03/16255
PCT Publication Date:	December 04, 2003	PCT Publication Number:	WO03/098992

International Family Members for US Patent 7,547,719

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1534390		C20100006 00032	Estonia
European Patent Office	1534390		PA2010007	Lithuania
European Patent Office	1534390		PA2010007,C1534390	Lithuania
European Patent Office	1534390		91 3-2010	Slovakia
European Patent Office	1534390		C 2010 013	Romania
European Patent Office	1534390		C20100006	Estonia