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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 thirty-nine patent family members in seventeen 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.

Indicators of Generic Entry

Summary for KIMYRSA

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	2
Patent Applications:	25
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

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 and three FDA Regulatory Exclusivities.

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
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

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

Country	Patent Number	Title	Estimated Expiration
China	106620649	使用单剂量奥利万星的治疗方法 (Methods of treatment using single doses of oritavancin)
European Patent Office	3006038	METHODES DE TRAITEMENT UTILISANT DES DOSES UNIQUES D'ORITAVANCINE (METHODS OF TREATMENT USING SINGLE DOSES OF ORITAVANCIN)
Mexico	2011002249	METODOS DE TRATAMIENTO UTILIZANDO DOSIS UNICAS DE ORITAVANCINA. (METHODS OF TREATMENT USING SINGLE DOSES OF ORITAVANCIN.)
Eurasian Patent Organization	201700019	ВЫСОКОЧИСТЫЙ ОРИТАВАНЦИН И СПОСОБ ЕГО ПОЛУЧЕНИЯ
Spain	2570401
China	107206050	高纯度奥利万星及其生产方法 (High purity oritavancin and method of producing same)
Canada	2955256	ORITAVANCINE A HAUTE PURETE ET SON PROCEDE DE PRODUCTION (HIGH PURITY ORITAVANCIN AND METHOD OF PRODUCING SAME)

Supplementary Protection Certificates for KIMYRSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	2016/040	Ireland		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575	CA 2016 00044	Denmark		PRODUCT NAME: ORITAVANCIN OG/ELLER FARMACEUTISKE SALTE HERAF, HERUNDER DIFOSFATSALTE; REG. NO/DATE: EU/1/15/989 20150323
2337575	41/2016	Austria		PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 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	300834	Netherlands		PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
2337575	1690041-7	Sweden		PRODUCT NAME: ORITAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/15/989 20150323
2337575	16C0039	France		PRODUCT NAME: ORITAVANCINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,TELS QUE LES SELS DIPHOSPHATES; REGISTRATION NO/DATE: EU/1/15/989 20150323

KIMYRSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KIMYRSA

Introduction to KIMYRSA

KIMYRSA, developed by Melinta Therapeutics, is a lipoglycopeptide antibiotic designed to treat acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Approved by the U.S. Food and Drug Administration in March 2021, KIMYRSA offers a single, one-hour, 1,200 mg infusion, marking a significant advancement in the treatment of ABSSSI[4].

Market Need and Demand

The market for antibiotics targeting MRSA and other antibiotic-resistant infections is driven by several critical factors:

• Increasing Prevalence of Antibiotic Resistance: The rising incidence of antibiotic-resistant infections, including MRSA, poses a significant challenge in healthcare settings. This has created a critical need for new and effective treatment options, driving demand for drugs like KIMYRSA[1][2].
• Clinical Utility: KIMYRSA addresses the need for a shorter infusion time and greater flexibility in treatment, making it an attractive option for both healthcare providers and patients. The drug's efficacy and safety were established in the SOLO clinical trials, demonstrating its effectiveness compared to traditional multi-dose regimens[4].

Competitive Landscape

The antibiotic resistance market is highly competitive, with several key players investing heavily in research and development:

• Market Players: Companies like Melinta Therapeutics, Basilea Pharmaceutica Ltd., and Tetraphase Pharmaceuticals are actively involved in developing and commercializing new antibiotics. These companies engage in merger and acquisition activities to expand their portfolios and geographic reach[2].
• Innovation: The field is undergoing significant innovation, with a focus on developing novel antibiotics and therapeutic strategies. KIMYRSA, with its unique one-hour infusion and compatibility with various diluents, stands out as a innovative solution in this space[4].

Financial Trajectory

The financial performance and potential of KIMYRSA are influenced by several factors:

• Revenue Potential: As part of the broader MRSA drugs market, which is projected to grow from $3.8 billion in 2023 to $5.5 billion by 2031 at a CAGR of 4.3%, KIMYRSA is poised to capture a significant share. The antibiotic resistance market as a whole is estimated to grow at a CAGR of 5.27% from 2024 to 2030, reaching $8.72 billion by 2030[1][2].
• Cost and Pricing: The development and commercialization of KIMYRSA are supported by substantial investments. For instance, the average cost of bringing a new drug to market is about $2.6 billion, but successful drugs can generate large revenue streams. KIMYRSA's pricing strategy will be crucial in capturing market share and generating revenue[3][4].

Regulatory and Government Support

Regulatory incentives and government support play a vital role in the financial trajectory of KIMYRSA:

• Regulatory Incentives: Regulatory agencies offer incentives such as expedited review processes, grants, and market exclusivity for new antibiotics targeting priority pathogens like MRSA. These incentives help offset the high costs and risks associated with antibiotic development, fostering innovation and ensuring a steady pipeline of new treatments[1].
• Government Initiatives: Government initiatives and policies aimed at addressing antimicrobial resistance provide a conducive environment for the development and commercialization of drugs like KIMYRSA. For example, the Biomedical Advanced Research and Development Authority (BARDA) has provided significant funding for the development of new antibiotics, including those targeting MRSA[5].

Market Segmentation and Target Audience

KIMYRSA is targeted at a specific segment within the antibiotic resistance market:

• Disease Segment: ABSSSI, particularly those caused by MRSA, is a significant segment. ABSSSIs affect approximately 14 million patients in the U.S. each year, resulting in substantial healthcare costs and hospital admissions[4].
• Geographic Focus: The initial commercial launch of KIMYRSA in the U.S. market is strategic, given the region's high incidence of antibiotic-resistant infections and strong healthcare infrastructure. North America, with its vigorous investment in research and development, is a key market for KIMYRSA[2].

Clinical and Economic Impact

The clinical and economic impact of KIMYRSA is substantial:

• Clinical Efficacy: KIMYRSA has been shown to be as effective as 7-to-10 days of twice-daily vancomycin in treating ABSSSI, offering a more convenient and potentially cost-effective treatment option[4].
• Economic Benefits: By reducing the length of hospital stays and the need for multiple doses, KIMYRSA can help lower healthcare costs associated with ABSSSI. The drug's compatibility with various diluents and shorter infusion time also enhance its economic viability[4].

Challenges and Opportunities

Despite the promising market dynamics, there are challenges and opportunities to consider:

• Regulatory Hurdles: The development and approval process for new antibiotics is stringent, requiring extensive clinical data. This can add time and costs to the development process, potentially delaying market entry[1].
• Market Expansion: The partnership between Melinta Therapeutics and other companies, such as Venatorx Pharmaceuticals, can expand the reach and portfolio of KIMYRSA, offering opportunities for growth in new markets and segments[5].

Key Takeaways

• Growing Demand: The increasing prevalence of antibiotic-resistant infections drives demand for innovative treatments like KIMYRSA.
• Regulatory Support: Government initiatives and regulatory incentives are crucial for the development and commercialization of new antibiotics.
• Clinical Utility: KIMYRSA's unique features, such as its one-hour infusion and compatibility with various diluents, make it an attractive option for treating ABSSSI.
• Financial Potential: As part of a growing market, KIMYRSA has significant revenue potential, supported by substantial investments and regulatory incentives.

FAQs

Q: What is KIMYRSA used for? A: KIMYRSA is used to treat acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

Q: How is KIMYRSA administered? A: KIMYRSA is administered as a single, one-hour, 1,200 mg infusion.

Q: What are the key benefits of KIMYRSA? A: KIMYRSA offers a shorter infusion time, greater flexibility in treatment, and compatibility with various diluents, making it a convenient and effective treatment option.

Q: What is the market potential for KIMYRSA? A: KIMYRSA is part of the growing MRSA drugs market and the broader antibiotic resistance market, which is projected to grow significantly over the next few years.

Q: What regulatory incentives support the development of KIMYRSA? A: Regulatory agencies offer incentives such as expedited review processes, grants, and market exclusivity to support the development of new antibiotics targeting priority pathogens like MRSA.

Cited Sources

1. Verified Market Research - MRSA Drugs Market Size, Forecast
2. Grand View Research - Antibiotic Resistance Market Size And Share Report, 2030
3. DrugBank Blog - Investment Trends in Pharmaceutical Research
4. Melinta Therapeutics - Commercial Availability of KIMYRSA™ (oritavancin)
5. Melinta Therapeutics - Licensing Agreement to Commercialize cefepime-taniborbactam in the U.S.