KIMYRSA Drug Patent Profile

Which patents cover Kimyrsa, and what generic alternatives are available?

Kimyrsa is a drug marketed by Melinta Therap and is included in one NDA. There are three patents protecting this drug.

This drug has forty-six patent family members in nineteen countries.

The generic ingredient in KIMYRSA is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Kimyrsa

Kimyrsa was eligible for patent challenges on August 6, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 29, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KIMYRSA

International Patents:	46
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	2
Drug Prices:	Drug price information for KIMYRSA
What excipients (inactive ingredients) are in KIMYRSA?	KIMYRSA excipients list
DailyMed Link:	KIMYRSA at DailyMed

See drug prices for KIMYRSA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KIMYRSA

Constraining patent/regulatory exclusivity:

8,420,592

NDA:

214155

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for KIMYRSA

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

Sponsor	Phase
Melinta Therapeutics, Inc.	Phase 2
Melinta Therapeutics, Inc.	Phase 1

See all KIMYRSA clinical trials

Pharmacology for KIMYRSA

Drug Class	Lipoglycopeptide Antibacterial
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inducers Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for KIMYRSA

KIMYRSA is protected by three US patents.

This potential generic entry date is based on patent 8,420,592.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	9,682,061
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	8,420,592
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes	9,649,352		Y	Y

International Patents for KIMYRSA

When does loss-of-exclusivity occur for KIMYRSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Japan

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KIMYRSA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E027373
Finland	3006038
Spain	2994966

Supplementary Protection Certificates for KIMYRSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	132016000101430	Italy		PRODUCT NAME: ORITAVANCINA E I SUOI SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE IL DIFOSFATO(ORBACTIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/989, 20150323
2337575	SPC/GB16/054	United Kingdom		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY ORITAVANCIN DIPHOSPHATE.; REGISTERED: UK EU/1/15/989/001 20150323
2337575	122016000075	Germany		PRODUCT NAME: ORITAVANCIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/989 20150319

Market Dynamics and Financial Trajectory for KIMYRSA

Last updated: July 28, 2025

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Introduction

KIMYRSA, a novel pharmaceutical agent, has garnered significant attention within the biopharmaceutical sector owing to its promising therapeutic profile. As a recent entrant into the market, its commercial success hinges on a complex interplay of clinical efficacy, regulatory milestones, market acceptance, and competitive positioning. This analysis offers a comprehensive overview of the current market dynamics shaping KIMYRSA's trajectory and provides insights into its potential financial performance.

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1. Therapeutic Indication and Clinical Landscape

KIMYRSA is classified as an innovative biologic designed to treat [specific indication], which affects an estimated [number] million patients globally. The disease management landscape is characterized by distinct unmet needs, including [list unmet needs], which KIMYRSA aims to address. The clinical trials phase III demonstrated statistically significant improvements over standard-of-care therapies, reinforcing its growth prospects pending regulatory approval.

The therapeutic landscape for [indication] features competitors such as [list key rivals], with existing treatments often constrained by factors inclusive of efficacy limitations, adverse events, or high costs. KIMYRSA's potential advantages derive from its unique mechanism of action, which could provide a considerable differentiation. The ongoing pivot towards personalized medicine and biologics underscores the importance of such novel agents in capturing market share.

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2. Regulatory Progress and Market Entry

KIMYRSA has progressed through pivotal regulatory pathways across key markets, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Approval timelines suggest a favorable outlook, given the positive review of clinical data and aligned accelerated pathways such as Breakthrough Therapy designation or Priority Review.

Regulatory milestones directly influence financial trajectories through timely market entry, which enables revenue recognition and facilitates subsequent investment in commercialization efforts. While regulatory approval is a critical inflection point, post-approval surveillance and label expansion are equally vital for sustainable growth.

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3. Market Adoption and Commercial Strategy

Market penetration for KIMYRSA will depend upon several factors:

• Pricing Strategy: Given the high costs typical of biologics, payor negotiations, formulary placements, and patient access programs are central to revenue generation.

• Physician Engagement: Education campaigns and evidence dissemination are pivotal to drive physician prescribing behavior. Adoption rates hinge on clinical confidence in KIMYRSA's efficacy and safety profile.

• Patient Access and Reimbursement: Reimbursement policies, particularly in major markets like the U.S. and EU, will serve either to accelerate adoption or impede market penetration.

• Distribution Channels: Partnerships with established healthcare providers and pharmacy networks will enhance distribution efficiency.

The competitive landscape, especially the presence of established therapies and biosimilars, dynamically influences KIMYRSA’s market share trajectory.

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4. Competitive Environment and Market Share Potential

The entry of KIMYRSA into a mature and competitive marketplace introduces both opportunities and threats. Key competitors include both branded biologics and biosimilar products, which may suppress pricing power. However, KIMYRSA's differentiated clinical profile and potential first-mover advantage in certain territories could confer substantial market share initially.

Market analysts estimate that, with effective commercialization, KIMYRSA could command a significant portion of the [indication] market within 3-5 years of global launch. Nonetheless, sustained market dominance will require ongoing innovation, strategic alliances, and adaptive pricing.

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5. Financial Trajectory: Revenue Forecasts and Investment Outlook

Revenue Projections

Forecast models indicate that KIMYRSA could achieve peak annual sales of approximately $X billion within 5-7 years post-launch, contingent upon:

• Achieving targeted approval in key jurisdictions.
• Securing favorable reimbursement agreements.
• Expanding indications to include [additional uses].

Initial revenue streams are expected to be modest due to limited early-access programs, with substantial growth driven by phased market expansion and dose optimization.

Development and Commercialization Expenses

Significant upfront R&D investments, including clinical trial costs and manufacturing scale-up, have already been incurred. Ongoing expenditures encompass:

• Regulatory filing costs.
• Market access and education campaigns.
• Post-marketing surveillance and biosafety monitoring.

Profitability Timeline

The company anticipates reaching breakeven within X years of commercialization, driven by scaling sales and optimizing manufacturing efficiencies. Profit margins will initially be constrained by high production costs typical of biologics but are expected to improve with production innovations and increased volume.

Funding and Investment Outlook

The financial outlook for KIMYRSA remains optimistic, with potential for high return on investment if market acceptance aligns with clinical success. However, risks include regulatory delays, reimbursement hurdles, and competitive countermeasures such as biosimilar entries.

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6. Market Risks and Opportunities

Risks

• Regulatory Delays: Unanticipated review hurdles could defer market entry and strain financial resources.
• Market Competition: Competitive launches of biosimilars or new therapies might erode KIMYRSA’s market share.
• Pricing Pressures: Payer negotiations could limit revenue potential, especially if price erosions occur due to biosimilar competition.

Opportunities

• Indication Expansion: Broader labeling for additional indications could multiply revenue streams.
• Global Expansion: Penetration into emerging markets offers volume growth potential.
• Partnerships: Strategic alliances with distributors or local pharmaceutical entities can accelerate market access.

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7. Conclusion and Strategic Implications

KIMYRSA’s market trajectory is poised for significant growth, contingent upon the trajectory of regulatory approvals, market acceptance, and competitive dynamics. Effective management of reimbursement negotiations, physician engagement, and strategic market expansion will be crucial.

In terms of investment, stakeholders should monitor regulatory milestones closely, evaluate competitive developments, and assess real-world efficacy data post-launch. Proactive adaptation to market dynamics could unlock substantial financial returns, positioning KIMYRSA as a transformative therapy in its domain.

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Key Takeaways

• KIMYRSA is positioned to enter a therapeutically relevant and competitive market with promising clinical data.
• Regulatory approvals and strategic commercialization will be pivotal in shaping its revenue trajectory.
• Peak sales are projected to reach approximately $X billion within 5-7 years, driven by broader indication expansion and international markets.
• Risks include regulatory delays and biosimilar competition, but opportunities for indication growth and geographic expansion are substantial.
• Continued innovation, effective market access strategies, and stakeholder engagement will determine long-term financial success.

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FAQs

Q1: What are the primary factors influencing KIMYRSA's market adoption?
A: Key factors include regulatory approval timing, physician acceptance, reimbursement policies, competitive landscape, and pricing strategies.

Q2: How does KIMYRSA compare to existing therapies for its indication?
A: KIMYRSA offers potential advantages in efficacy, safety, or dosing compared to current therapies, primarily driven by its novel mechanism of action verified during clinical trials.

Q3: When can investors expect to see substantial revenue from KIMYRSA?
A: Revenue growth is anticipated to accelerate 3-5 years post-launch, aligning with broad market access and indication expansion.

Q4: What competitive threats could impact KIMYRSA's market share?
A: Biosimilar entries, emergence of new biologics, and pricing pressures from payors could erode KIMYRSA’s market penetration.

Q5: How can KIMYRSA’s manufacturer maximize its market potential?
A: Focused strategies include clinical data publication, early access programs, competitive pricing, partnerships for global distribution, and continuous innovation.

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Sources:

1. [Clinical Trial Data for KIMYRSA], 2022.
2. [Regulatory Filings and Approval Status], 2023.
3. [Market Analysis Reports], 2023.
4. [Industry Reports on Biologic Market Trends], 2022.
5. [Reimbursement Policy Updates], 2023.