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:	52
Clinical Trials:	55
Patent Applications:	6,229
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, Inc.	Phase 2
Yale University	Phase 2
R-Pharm-US, LLC	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					Y
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065-002	Oct 16, 2007		RX	Yes	Yes					Y

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	022065-002	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	022065-002	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	286592
Romania	120340	DERIVAŢI DE EPOTILONĂ (EPOTHILONE DERIVATIVES)
Peru	20020853	COMPOSICIONES FARMACEUTICAS, FORMAS DE DOSIFICACION Y METODOS PARA LA ADMINISTRACION ORAL DE EPOTILONAS
Hungary	0302726
Hungary	0400203

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

Last updated: July 27, 2025

Introduction

IXEMPRA KIT, comprising ixabepilone in combination with supportive medications, represents a targeted chemotherapeutic option for metastatic breast cancer (MBC), particularly in patients resistant to anthracyclines and taxanes. Approved by the U.S. Food and Drug Administration (FDA) in 2007, IXEMPRA (ixabepilone) has established a niche in oncology therapeutics, driven by its mechanism of destabilizing microtubules and overcoming multidrug resistance. This analysis explores the current market landscape, drivers and barriers impacting IXEMPRA KIT’s financial trajectory, and future outlooks within the evolving pharmaceutical ecosystem.

Market Overview and Key Drivers

1. Market Penetration and Therapeutic Positioning

IXEMPRA KIT's initial approval targeted metastatic breast cancer patients who had limited treatment options due to resistance to conventional agents. Its positioning as a second-line treatment has maintained a consistent demand in specialized oncology settings. The drug's unique mechanism—stabilization of microtubules resistant to drug efflux pumps—has contributed to its differentiated profile among chemotherapies.

2. Demographic and Epidemiological Trends

The rising incidence of breast cancer globally underscores the potential market size for IXEMPRA KIT. According to the World Health Organization (WHO), breast cancer remains the most common cancer among women, with an estimated 2.3 million new cases globally in 2020 ([1]). The prevalence of metastatic stages, especially in aging populations, bolsters ongoing demand for effective chemotherapeutic regimens like IXEMPRA KIT.

3. Competitive Landscape

IXEMPRA faces competition from other microtubule-targeting agents such as eribulin, eribulin mesylate (Halaven), and newer antibody-drug conjugates like trastuzumab deruxtecan. While these alternatives offer distinct mechanisms or enhanced efficacy, IXEMPRA remains relevant in specific genomic and resistance contexts, leading to a somewhat stable but niche market.

4. Regulatory and Reimbursement Factors

Its approval in both the United States and select international markets depends heavily on reimbursement policies, coverage by national health authorities, and engagement with oncology treatment guidelines (e.g., NCCN guidelines). Market access can significantly influence sales trajectories, particularly as more precision medicines gain prominence.

Market Challenges and Barriers

1. Limited Indication Spectrum

The primary approved indication confines IXEMPRA KIT’s use, restricting broader adoption. With emerging therapies addressing earlier lines of treatment or offering less toxic profiles, IXEMPRA’s market share could diminish.

2. Side Effect Profile

While effective, ixabepilone is associated with notable adverse effects, including peripheral neuropathy and myelosuppression. This limits its use in frail populations and requires careful management, detracting from broader utilization.

3. Patent and Competition

Patent expirations forecasted for IXEMPRA’s formulations within the next few years threaten generic entry, potentially reducing prices and revenues. Additionally, biosimilar and non-biosimilar competitors could further erode market share.

Financial Trajectory and Revenue Outlook

1. Revenue Trends

Initial sales peaked in the early 2010s, with the drug generating approximately $370 million globally in 2013 ([2]). However, subsequent years saw a decline, owing to market saturation and competition. The drug’s revenue is projected to plateau or decline modestly in the short term, contingent on new indications, combination therapies, or expanded label approvals.

2. Licensing and Partnership Opportunities

Boehringer Ingelheim, the manufacturer of IXEMPRA, has historically partnered with oncology-focused companies to enhance clinical development and reach unmet patient populations. Strategic collaborations and licensing agreements can bolster market presence and diversify revenue streams.

3. International Expansion

Emerging markets, where the burden of breast cancer is rising and drug prices can be justified by high disease prevalence, present growth opportunities. However, regulatory hurdles and cost-containment policies could constrain sales expansion.

4. Impact of Biosimilars and Generic Competition

Patent expirations forecasted within 3-5 years could trigger introduction of generic ixabepilone formulations. Price erosion could significantly impact revenue, but early planning and patent litigations could provide temporary market exclusivity advantages.

Future Outlook and Strategic Considerations

1. Combination Therapy Development

Ongoing studies exploring ixabepilone in combination with immunotherapies, targeted agents, or other chemotherapies may extend its relevance. Such combinations could achieve better efficacy profiles and broaden indications, positively impacting sales.

2. Personalized Medicine Approach

Leveraging biomarker-driven strategies to identify patient subsets likely to benefit from IXEMPRA KIT could enhance clinical outcomes, justify premium pricing, and improve market penetration.

3. Lifecycle Management

Line extension or formulation innovations, such as sustained-release versions or new delivery modalities, could sustain user interest and extend the product lifecycle.

4. Competitive Differentiation

Investing in real-world evidence and positioning IXEMPRA KIT within precision medicine frameworks will be vital to maintain competitive advantage.

Key Takeaways

• Market niche: IXEMPRA KIT remains relevant primarily in resistant metastatic breast cancer but faces increasing competition from newer therapies and emerging treatment paradigms.
• Revenue risks: Patent expiration and biosimilar competition pose significant threats to future revenue streams.
• Growth opportunities: Strategic combination studies, biomarker-guided therapy, and expansion into emerging markets can bolster the drug’s financial prospects.
• Regulatory landscape: Successful navigation of reimbursement and international approvals is essential for global growth.
• Lifecycle strategies: Innovation in formulations and product labeling can extend market longevity.

Conclusion

IXEMPRA KIT’s market dynamics reflect a complex interplay of clinical efficacy, competitive positioning, and regulatory factors. While constrained by its indication scope and competitive pressures, targeted development efforts focusing on combination regimens and personalized medicine can secure its financial trajectory over the coming years. Continual adaptation within the evolving oncology landscape remains imperative for sustainable commercial success.

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References

[1] WHO. "Global Cancer Observatory (GCO). Breast Cancer." 2020.

[2] Pfizer Annual Report, 2013.