IXEMPRA KIT Drug Patent Profile

Which patents cover Ixempra Kit, and what generic alternatives are available?

Ixempra Kit is a drug marketed by R-pharm Us Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in twenty-six countries.

The generic ingredient in IXEMPRA KIT is ixabepilone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ixabepilone profile page.

DrugPatentWatch^® Generic Entry Outlook for Ixempra Kit

Ixempra Kit was eligible for patent challenges on October 16, 2011.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for IXEMPRA KIT

International Patents:	34
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	55
Patent Applications:	7,024
Drug Prices:	Drug price information for IXEMPRA KIT
DailyMed Link:	IXEMPRA KIT at DailyMed

See drug prices for IXEMPRA KIT

Recent Clinical Trials for IXEMPRA KIT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
R-Pharm-US, LLC	Phase 2
R-Pharm US, Inc.	Phase 2
Yale University	Phase 2

See all IXEMPRA KIT clinical trials

Paragraph IV (Patent) Challenges for IXEMPRA KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IXEMPRA KIT	Injection	ixabepilone	15 mg/vial and 45 mg/vial, single- use vials	022065	1	2012-04-16

US Patents and Regulatory Information for IXEMPRA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007		RX	Yes	Yes
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007		RX	Yes	Yes

Expired US Patents for IXEMPRA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-001	Oct 16, 2007

International Patents for IXEMPRA KIT

See the table below for patents covering IXEMPRA KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	11082003	Kombinácia analógov epotilónu a chemoterapeutických činidiel na liečenie proliferatívnych ochorení (Combination of epotilone analogues and chemotherapeutic agents for treatment of proliferative diseases)
Hungary	0103111
Georgia, Republic of	P20032897	Epothilone Derivatives
European Patent Office	1019389	DERIVES D'EPOTHILONE (EPOTHILONE DERIVATIVES)

Supplementary Protection Certificates for IXEMPRA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1019389	C01019389/01	Switzerland		PRODUCT NAME: IXABEPILONE; REGISTRATION NUMBER/DATE: SWISSMEDIC 58880 27.02.2009

Market Dynamics and Financial Trajectory for IXEMPRA Kit

Introduction

IXEMPRA Kit, containing the chemotherapeutic agent ixabepilone, is a crucial treatment option for patients with metastatic or locally advanced breast cancer. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its acquisition, clinical significance, market performance, and financial implications.

Acquisition and Commercialization

In 2015, R-PHARM US acquired IXEMPRA from Bristol-Myers Squibb (BMS), marking a significant milestone in the drug's commercialization. This acquisition enabled R-PHARM US to launch its U.S. commercial operations, taking over all aspects of IXEMPRA's manufacture, distribution, sales, and reimbursement[1].

Clinical Significance

IXEMPRA is indicated for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. Clinical trials have demonstrated its efficacy, particularly in combination with capecitabine, showing improved progression-free survival in patients with triple-negative metastatic breast cancer[2].

Market Approval and Global Reach

IXEMPRA received marketing approval from the U.S. Food and Drug Administration (FDA) in 2007 and has been approved in 18 other markets globally. However, its European approval was complicated by a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) in 2008, leading to the withdrawal of the European NDA[2].

Market Performance

The market performance of IXEMPRA has been influenced by several factors, including its efficacy in clinical trials and the competitive landscape of breast cancer treatments. The drug has strong brand recognition in the oncology community, which has been a key factor in its market presence. R-PHARM US has focused on ensuring broad formulary and reimbursement coverage to maintain and expand its market share[1].

Sales and Distribution

Following the acquisition, R-PHARM US launched a sales force to support IXEMPRA in the physician's office. The company has also collaborated with other entities, such as Otsuka Pharmaceutical, to enhance the drug's distribution and sales. For instance, Otsuka was to sell IXEMPRA on a regressive tiering basis on behalf of BMS from 2010 to 2020[2].

Financial Trajectory

Acquisition Costs and Funding

The financial terms of the acquisition of IXEMPRA by R-PHARM US were not disclosed. However, the acquisition was supported by financial backing from OrbiMed of New York, NY, and legal advice from Dechert LLP of Washington, DC[1].

Budget Impact Analysis

A budget impact analysis estimated the financial implications of introducing IXEMPRA into a health plan. For a hypothetical 1 million-member commercial plan, the incremental cost per member per month (PMPM) was relatively small, ranging from $0.002 to $0.004 over a three-year period. The analysis suggested that the budget impact was manageable, especially considering the limited number of patients eligible for IXEMPRA treatment[3].

Revenue and Market Share

R-PHARM US, as a subsidiary of R-PHARM CJSC, has a significant global presence, with sales of $1.5 billion primarily in Russia and Eastern Europe in 2014. The acquisition of IXEMPRA was part of a strategy to identify and acquire underserved pharmaceutical products that could become growth brands with focused commercialization support in the U.S. market[1].

Challenges and Risks

Adverse Reactions and Contraindications

IXEMPRA is associated with several adverse reactions, including peripheral sensory neuropathy, myelosuppression, and hypersensitivity reactions. These risks necessitate careful patient monitoring and dose adjustments, which can impact the drug's market performance and patient compliance[4].

Regulatory Hurdles

The drug faced regulatory challenges, particularly in Europe, where the CHMP issued a negative opinion. Such regulatory setbacks can significantly impact the drug's global market reach and revenue potential[2].

Future Prospects

Ongoing Clinical Trials

Allarity Therapeutics A/S initiated a Phase 2 trial of IXEMPRA in the European Union in 2021, aiming to advance the drug towards registrational approval and commercialization in Europe. This trial, combined with the use of a DRP® companion diagnostic, is expected to further establish the drug's efficacy and safety profile[5].

Market Expansion

The ongoing efforts to expand IXEMPRA's market presence, including new clinical trials and strategic partnerships, are crucial for its long-term financial success. R-PHARM US's commitment to ensuring broad formulary and reimbursement coverage will continue to be vital in maintaining and growing the drug's market share.

Key Takeaways

• Acquisition and Commercialization: R-PHARM US acquired IXEMPRA from BMS in 2015, launching its U.S. commercial operations.
• Clinical Significance: IXEMPRA is effective in treating metastatic or locally advanced breast cancer, particularly in combination with capecitabine.
• Market Approval: Approved in the U.S. in 2007 and in 18 other global markets, but faced regulatory challenges in Europe.
• Market Performance: Strong brand recognition and focused commercialization efforts have supported its market presence.
• Financial Trajectory: Manageable budget impact, supported by financial backing and strategic partnerships.
• Challenges and Risks: Associated with adverse reactions and regulatory hurdles.
• Future Prospects: Ongoing clinical trials and market expansion efforts are critical for its long-term success.

FAQs

What is IXEMPRA used for?

IXEMPRA is used for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

Who acquired IXEMPRA from Bristol-Myers Squibb?

R-PHARM US acquired IXEMPRA from Bristol-Myers Squibb in 2015.

What are the common adverse reactions associated with IXEMPRA?

Common adverse reactions include peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, stomatitis/mucositis, and myelosuppression.

How does IXEMPRA impact the budget of a health plan?

The incremental cost per member per month (PMPM) for introducing IXEMPRA into a health plan is relatively small, ranging from $0.002 to $0.004 over a three-year period.

Are there ongoing clinical trials for IXEMPRA?

Yes, Allarity Therapeutics A/S initiated a Phase 2 trial of IXEMPRA in the European Union in 2021 to advance the drug towards registrational approval and commercialization.

Sources

1. GlobeNewswire: R-PHARM Acquires IXEMPRA(R) (ixabepilone) From Bristol-Myers Squibb and Launches U.S. Commercial Operations[1].
2. Clinical Trials Arena: Ixempra (Ixapebilone) chemotherapeutic agent – New Cancer Therapy[2].
3. PubMed: Budget impact analysis of ixabepilone used according to FDA-approved indications[3].
4. FDA: IXEMPRA Kit (ixabepilone) for injection, for intravenous use[4].
5. GlobeNewswire: Allarity Therapeutics A/S[5].