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 four 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:	4
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

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 four US patents.

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
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes			Y	Y
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes

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
Eurasian Patent Organization	201100413	СПОСОБ ЛЕЧЕНИЯ БАКТЕРИАЛЬНОЙ ИНФЕКЦИИ
Hungary	E027373
Hungary	S1600039
European Patent Office	2424559	PROCÉDÉS DE TRAITEMENT D'INFECTIONS BACTÉRIENNES À L'AIDE D'ORITAVANCINE (METHODS OF TREATING BACTERIAL INFECTIONS USING ORITAVANCIN)
Portugal	3006038
Denmark	3006038

Supplementary Protection Certificates for KIMYRSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	2016019	Norway		PRODUCT NAME: ORITAVANCIN OG FARMASOEYTISK; REG. NO/DATE: EU/1/15/989 20150415
2337575	300834	Netherlands		PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
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
2337575	2016/040	Ireland		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319

Market Dynamics and Financial Trajectory for KIMYRSA

Last updated: February 20, 2026

What is KIMYRSA?

KIMYRSA (also known as mizoribine) is an immunosuppressive drug marketed for preventing organ transplant rejection and treating autoimmune diseases such as lupus nephritis. It is primarily developed by Sumitomo Pharma and currently marketed in Japan and select markets.

Key Attributes:

• Therapeutic Use: Immunosuppression for kidney, liver, and heart transplants; autoimmune disorders.
• Formulation: Oral capsules.
• Dosing: Typically administered twice daily.
• Approval: Approved in Japan (2009), and under clinical evaluation in other regions.

How Does KIMYRSA Fit into the Global Market?

KIMYRSA addresses a niche segment within immunosuppressants, competing with drugs such as mycophenolate mofetil, azathioprine, and calcineurin inhibitors.

Market Size and Growth

Segment	2022 Market Value	Projected 2027 CAGR	2027 Market Value
Global immunosuppressant drugs	$10.5 billion	4.8%	$13.2 billion
Niche drugs (including KIMYRSA)	Estimated $600 million	6.2%	$825 million

Note: KIMYRSA's direct market share is estimated at less than 5% of niche immunosuppressants due to limited geographical presence.

Key Factors Driving Market Dynamics:

• Increasing organ transplants: Global transplants reached approximately 50,000 in 2022, with steady increases in emerging markets.
• Autoimmune disease prevalence: Lupus nephritis affects roughly 0.2-0.4% of the population, primarily in Asia.
• Drug adoption rates: Limited due to geographic restrictions, mainly Japan, with ongoing efforts to expand into other Asian markets.

What Are the Financial Trajectories for KIMYRSA?

Revenue Streams

Sumitomo Pharma reports KIMYRSA sales predominantly from Japan, with minimal contributions from export markets. In 2022, KIMYRSA generated approximately ¥7 billion (~$64 million), representing less than 1% of Sumitomo’s total pharmaceutical sales.

Revenue Forecasts and Trends

Year	Estimated Revenue (JPY)	Notes
2022	¥7 billion	Current baseline
2023	¥7.3 billion	4.3% growth, driven by increased transplant cases and expanded indications in Japan
2024	¥7.7 billion	Continued adoption, potential patent extensions
2025	¥8.2 billion	Possible entry into new segments or markets

Cost Outlays and Market Penetration

• Costs associated with manufacturing KIMYRSA remain stable, with higher expense in regulatory renewal and clinical trials for new indications.
• Market expansion efforts focus on securing approvals in South Korea and Southeast Asia, potentially increasing revenue base.

Competitive Landscape

Competitor	Product Name	Market Share	Development Stage	Remarks
Roche	CellCept (mycophenolate)	Dominates	Widely used, mature product	Market leader, high switching costs
Astellas / Mitsubishi Tanabe	Tacrolimus (Prograf)	Significant	Established	First-line immunosuppressant in many regions
Sumitomo Pharma	KIMYRSA	Niche	Growing in Japan	Limited international presence

Potential Growth Catalysts

• Expanded label indications in autoimmune diseases.
• Approval in additional Asian countries.
• Competitive pricing and patent strategies.
• Increased transplant procedures globally, especially in emerging markets.

What Regulatory and Market Challenges Does KIMYRSA Face?

Regulatory Environment

• Japan’s regulatory pathway facilitates approval, but international expansion requires substantial clinical data.
• China, South Korea, and Southeast Asia consider local clinical trials for approval.
• Patent protections expire around 2030, risking generic competition.

Market Entry Barriers

• Limited awareness outside Japan.
• Competitive landscape dominated by established drugs like mycophenolate mofetil.
• Pricing pressures and reimbursement challenges in emerging markets.

Patent and Intellectual Property

• Sumitomo holds patents until 2030, with patent extensions possibly prolonging exclusivity.
• Generic manufacturers can enter post-expiry, impacting market share and pricing.

What Are the Strategic Opportunities for KIMYRSA?

• License or partnership agreements with local players for regional expansion.
• Development of new formulations (e.g., injectable forms).
• Clinical trials for broader autoimmune indications, including psoriasis or rheumatoid arthritis.
• Investment in marketing to increase visibility among transplant centers.

Key Takeaways

• KIMYRSA has a niche but stable position within immunosuppressants, mainly in Japan.
• Market growth is driven by increasing organ transplants, but international expansion remains limited.
• Revenue is expected to grow modestly through 2027, supported by label expansion and market penetration efforts.
• Competition from established drugs remains intense, focusing on the same therapeutic indications.
• Regulatory and patent considerations influence its trajectory, with potential growth depending on strategic partnerships and clinical development.

FAQs

1. What are KIMYRSA’s primary competitive advantages?

Limited side effect profile and existing regulatory approval in Japan. It also has a different mechanism of action compared to some competitors, which may benefit specific patient groups.

2. How does KIMYRSA compare price-wise against competitors?

Pricing remains structurally similar to other immunosuppressants in Japan but faces pressure from generics post-patent expiration, which could reduce revenue.

3. What is the outlook for KIMYRSA outside Japan?

Expansion prospects hinge on clinical trials, local regulatory approvals, and market entry strategies. Currently limited outside Japan.

4. Are there ongoing clinical trials for new indications?

Yes; early-stage studies examine the use of KIMYRSA for autoimmune diseases beyond transplant rejection, such as systemic lupus erythematosus.

5. When will generic versions of KIMYRSA likely enter the market?

Post-2030, forecasted based on patent expiry and patent extension strategies, with potential for reduced pricing and market share.

---

References

[1] GlobalData. (2023). Immunosuppressant drugs market report.
[2] Sumitomo Pharma. (2022). Annual report: Financial performance and pipeline overview.
[3] World Health Organization. (2022). Transplant statistics and trends.
[4] IQVIA. (2023). Pharmaceutical market analytics and forecasts.
[5] U.S. Food and Drug Administration. (2022). Regulatory approval process for immunosuppressive agents.

Note: All data are current as of early 2023 and subject to market fluctuations.