Details for Patent: 10,166,181

Which drugs does patent 10,166,181 protect, and when does it expire?

Patent 10,166,181 protects TRIPTODUR KIT and TRELSTAR and is included in two NDAs.

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

Summary for Patent: 10,166,181

Title:	Slow release pharmaceutical composition made of microgranules
Abstract:	Pharmaceutical composition made of microparticles for the slow release of an active substance at least during a period covering the 6th month after injection of said composition, said composition comprising a group of microparticles made of a copolymer of the PLGA type which incorporate an active substance in the form of a water insoluble peptide salt; said copolymer furthermore comprising at least 75% of lactic acid and an inherent viscosity between 0.1 and 0.9 dl/g, as measured in chloroform at 25.degree. C. and at a polymer concentration of 0.5 g/dL; said microparticles furthermore having a size distribution defined as follows: --D (v,0.1) is between 10 and 30 micrometers, --D (v,0.5) is between 30 and 70 micrometers, --D (v,0.9) is between 50 and 1 10 micrometers.
Inventor(s):	Ducrey; Bertrand (Martigny, CH), Garrouste; Patrick (Saxon, CH), Curdy; Catherine (Riehen, CH), Bardet; Marie-Anne (Maracon, CH), Porchet; Herve (Cugy, CH), Lundstrom; Eija (Lutry, CH), Heimgartner; Frederic (Marin-Epagnier, CH)
Assignee:	Debiopharm Research & Manufacturing SA (CH)
Application Number:	12/601,649
Patent Claim Types: see list of patent claims	Composition; Formulation;

Detailed Analysis of the Scope and Claims of United States Patent 10,166,181

Introduction

United States Patent 10,166,181, titled "Slow release pharmaceutical composition made of microgranules," is a significant patent in the pharmaceutical industry, particularly for the drug Trelstar, which contains the active ingredient triptorelin pamoate. This patent, assigned to Debiopharm Research & Manufacturing SA, protects a specific formulation and delivery method for this medication.

Patent Overview

The patent was issued on January 1, 2019, and is set to expire in June 2029, approximately 4 years from the current date[2][5].

Inventors and Assignees

The patent was invented by a team including Ducrey Bertrand, Garrouste Patrick, Curdy Catherine, Bardet Marie-Anne, Porchet Herve, Lundstrom Eija, and Heimgartner Frederic. The assignee is Debiopharm Research & Manufacturing SA[5].

Patent Claims and Scope

The patent claims cover a pharmaceutical composition made of microparticles designed for the slow release of an active substance, specifically a water-insoluble peptide salt, over an extended period. Here are the key aspects of the patent claims:

Composition

• The composition consists of microparticles made of a copolymer of lactic and glycolic acid (PLGA), which incorporates the active substance triptorelin pamoate[4].
• The PLGA copolymer must have at least 75% lactic acid content and an inherent viscosity between 0.1 and 0.9 dl/g, measured in chloroform at 25°C and a polymer concentration of 0.5 g/dL[4].

Microparticle Size and Distribution

• The microparticles have a specific size distribution: D (v,0.1) between 10 and 30 micrometers, and D (v,0.9) between 50 and 110 micrometers. This ensures a consistent release profile[4].

Release Profile

• The composition is designed to release the active substance over at least a 6-month period following injection. This slow release is crucial for the therapeutic efficacy of triptorelin pamoate, which is used to treat conditions such as prostate cancer and precocious puberty[4].

Patent Landscape and Exclusivity

Patent Protection

The patent provides exclusive rights to Debiopharm Research & Manufacturing SA for the specific formulation and delivery method described. This protection extends to the United States and is part of a broader international patent strategy, with patents in multiple countries[2].

Generic Availability

As of the current date, there is no therapeutically equivalent generic version of Trelstar available in the United States. This is largely due to the patent protection afforded by US Patent 10,166,181 and other related patents[5].

Legal and Regulatory Aspects

• The patent expires in June 2029, but the exclusivity period granted by the FDA may run concurrently or separately, depending on the specific circumstances of the drug's approval[5].
• The patent landscape includes various legal events and oppositions, particularly in Europe, which can affect the global market entry strategy for generic versions[2].

Impact on the Pharmaceutical Industry

Innovation and Competition

The broad scope of this patent, particularly the genus claims covering a class of PLGA copolymers, makes it challenging for competitors to design around the patent without infringing on the claims. This is a common issue in the pharmaceutical industry, where broad patent claims can stifle innovation while narrow claims can be easily circumvented[3].

Regulatory Challenges

The Federal Circuit's current position on genus claims and the written description requirement under 35 U.S.C. § 112(a) has made it difficult for pharmaceutical and biotechnology companies to obtain meaningful patent protection. This jurisprudence requires patentees to make and test all species within a genus, which is a significant burden[3].

Clinical and Therapeutic Implications

Therapeutic Efficacy

The slow release formulation protected by this patent ensures a consistent and prolonged therapeutic effect of triptorelin pamoate, which is critical for managing chronic conditions such as prostate cancer and precocious puberty[4].

Patient Compliance

The extended release profile enhances patient compliance by reducing the frequency of injections, which can improve treatment outcomes and quality of life for patients[4].

Conclusion

United States Patent 10,166,181 is a pivotal patent in the pharmaceutical industry, particularly for the drug Trelstar. It protects a unique formulation and delivery method that ensures the slow release of triptorelin pamoate over an extended period. The patent's broad claims and the regulatory landscape surrounding it highlight the complexities and challenges in the pharmaceutical patent space.

Key Takeaways

• The patent protects a specific PLGA-based microparticle formulation for the slow release of triptorelin pamoate.
• The patent expires in June 2029, but no generic version is currently available in the United States.
• The broad scope of the patent claims makes it challenging for competitors to design around without infringing.
• Regulatory challenges, such as those posed by the Federal Circuit's position on genus claims, affect the ability to obtain meaningful patent protection in the pharmaceutical industry.

FAQs

What is the main subject of United States Patent 10,166,181?

The main subject is a pharmaceutical composition made of microparticles for the slow release of triptorelin pamoate.

Who is the assignee of this patent?

The assignee is Debiopharm Research & Manufacturing SA.

When is the patent set to expire?

The patent is set to expire in June 2029.

Is a generic version of Trelstar available in the United States?

No, there is currently no therapeutically equivalent generic version of Trelstar available in the United States.

What are the regulatory challenges associated with this patent?

The patent faces regulatory challenges related to genus claims and the written description requirement under 35 U.S.C. § 112(a), which can make it difficult to obtain meaningful patent protection.

Cited Sources:

1. DrugPatentWatch - Generic TRIPTORELIN PAMOATE INN entry, drug patent and ...
2. Pharsight - Trelstar patent expiration
3. DigitalCommons@NYLS - Eviscerating Patent Scope
4. Google Patents - Slow release pharmaceutical composition made of microgranules
5. Drugs.com - Generic Trelstar Availability

Drugs Protected by US Patent 10,166,181

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	TRIPTODUR KIT	triptorelin pamoate	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	208956-001	Jun 29, 2017		RX	Yes	Yes	10,166,181		Y
Verity	TRELSTAR	triptorelin pamoate	INJECTABLE;INTRAMUSCULAR	022437-001	Mar 10, 2010		RX	Yes	Yes	10,166,181		Y

Foreign Priority and PCT Information for Patent: 10,166,181

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	07109767	Jun 6, 2007
	PCT/IB2007/054372	Oct 27, 2007

PCT Information
PCT Filed	June 06, 2008	PCT Application Number:	PCT/IB2008/052241
PCT Publication Date:	December 11, 2008	PCT Publication Number:	WO2008/149320

International Family Members for US Patent 10,166,181

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	3000
Australia	2008259411
Brazil	PI0812250