DAPZURA RT Drug Patent Profile

When do Dapzura Rt patents expire, and what generic alternatives are available?

Dapzura Rt is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. There is one patent protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in DAPZURA RT is daptomycin. There are ten drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dapzura Rt

A generic version of DAPZURA RT was approved as daptomycin by TEVA PHARMS USA on March 25^th, 2016.

Summary for DAPZURA RT

International Patents:	7
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Patent Applications:	2,451
What excipients (inactive ingredients) are in DAPZURA RT?	DAPZURA RT excipients list
DailyMed Link:	DAPZURA RT at DailyMed

Pharmacology for DAPZURA RT

Drug Class

Lipopeptide Antibacterial

US Patents and Regulatory Information for DAPZURA RT

DAPZURA RT is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	DAPZURA RT	daptomycin	POWDER;INTRAVENOUS	213645-001	Jan 25, 2022		DISCN	Yes	No			Y

EU/EMA Drug Approvals for DAPZURA RT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Daptomycin Hospira	daptomycin	EMEA/H/C/004310 Daptomycin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	yes	no	no	2017-03-22
Merck Sharp & Dohme B.V.	Cubicin	daptomycin	EMEA/H/C/000637 Cubicin is indicated for the treatment of the following infections.Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2006-01-19

International Patents for DAPZURA RT

See the table below for patents covering DAPZURA RT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2021233893	Daptomycin formulations containing a combination of sorbitol and mannitol
World Intellectual Property Organization (WIPO)	2021183752
China	115243675	含有山梨糖醇和甘露糖醇的组合的达托霉素制剂 (Daptomycin formulations containing combination of sorbitol and mannitol)
Brazil	112022015170	FORMULAÇÕES DE DAPTOMICINA CONTENDO UMA COMBINAÇÃO DE SORBITOL E MANITOL
Canada	3170514	FORMULATIONS DE DAPTOMYCINE CONTENANT UNE ASSOCIATION DE SORBITOL ET DE MANNITOL (DAPTOMYCIN FORMULATIONS CONTAINING A COMBINATION OF SORBITOL AND MANNITOL)
Japan	2023517926	ソルビトールとマンニトールの組み合わせを含むダプトマイシン製剤
European Patent Office	4117625	FORMULATIONS DE DAPTOMYCINE CONTENANT UNE ASSOCIATION DE SORBITOL ET DE MANNITOL (DAPTOMYCIN FORMULATIONS CONTAINING A COMBINATION OF SORBITOL AND MANNITOL)

Supplementary Protection Certificates for DAPZURA RT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN
1115417	SZ 22/2006	Austria		PRODUCT NAME: DAPTOMYCIN
1115417	06C0022	France		PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119
1115417	SPC/GB06/024	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB06/024 GRANTED TO CUBIST PHARMACEUTICALS, INC IN RESPECT OF THE PRODUCT DAPTOMYCIN, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6162 DATED 27 JUNE 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22 JANUARY 2021.
1115417	22/2006	Austria		PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119

DAPZURA RT Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for DAPZURA RT

Introduction

DAPZURA RT, a formulation of the antibiotic daptomycin, is a crucial drug in the treatment of certain bacterial infections. To understand its market dynamics and financial trajectory, it is essential to delve into various aspects including market trends, pricing, and the broader pharmaceutical industry context.

Market Trends in Pharmaceutical Spending

The pharmaceutical market has seen significant growth over the past few decades. In Canada, for example, total drug purchases increased by 184% in the retail sector and 309% in the hospital sector from 2001 to 2021[1].

Global Prescription Drug Market

Globally, the prescription drug market has experienced substantial growth. Between 2017 and 2022, sales revenues in the U.S. grew by 22%, while the rest of the world and OECD countries (excluding the U.S.) saw growth rates of 9% and 6%, respectively[4].

Pricing and Revenue Dynamics

Average Price Per Unit

The average price per unit for prescription drugs, including biological products like DAPZURA RT, has increased significantly. In the U.S., there was a 61% increase in sales revenues for biological products between 2017 and 2022. This trend indicates that high-priced drugs, such as DAPZURA RT, contribute substantially to the overall revenue growth in the pharmaceutical market[4].

Market Share of Biological Products

Biological products, which include drugs like DAPZURA RT, have been gaining market share. In 2022, biological products accounted for a significant portion of sales revenues, with the U.S. market showing a particularly high share compared to other regions[4].

Financial Performance of the Pharmaceutical Industry

Consolidation and R&D Spending

The pharmaceutical industry has undergone significant consolidation, which can impact R&D spending and drug prices. Consolidation can lead to fewer drug choices and higher prices due to reduced competition. However, it also allows for more focused R&D efforts, potentially leading to the development of innovative drugs like DAPZURA RT[3].

Profit Margins and Mergers

The financial performance of pharmaceutical companies has been robust, with high profit margins compared to other industries. Mergers and acquisitions have been common, allowing companies to expand their portfolios and reduce costs, which can influence the pricing and availability of drugs like DAPZURA RT[3].

Specifics of DAPZURA RT

Dosage and Administration

DAPZURA RT is administered based on specific dosage guidelines, including adjustments for patients with renal impairment. For adult patients with creatinine clearance (CLCR) less than 30 mL/min, the dosage is adjusted to 4 mg/kg or 6 mg/kg once every 48 hours, depending on the type of infection[2].

Market Position

Given its specific indications and dosage requirements, DAPZURA RT occupies a niche in the antibiotic market. Its pricing is influenced by the broader trends in biological products and the overall pharmaceutical market.

Pricing Strategies

Comparative Pricing

The pricing of DAPZURA RT is likely influenced by the prices of similar antibiotics and the overall market dynamics. In regions where prices are higher, such as the U.S., the revenue generated from DAPZURA RT would be significant compared to other markets[4].

Volume and Sales Revenue

The volume of DAPZURA RT sales may be lower in regions with higher prices due to the higher cost per unit. However, the sales revenue can still be substantial due to the premium pricing of biological products[4].

Regulatory Environment

FDA Approval and Guidelines

DAPZURA RT, like other drugs, must comply with FDA regulations and guidelines. The drug's prescribing information, including indications, contraindications, and interactions, is developed based on FDA standards[5].

Future Outlook

Market Growth

The market for prescription drugs, including biological products like DAPZURA RT, is expected to continue growing. The forecast indicates moderate to high growth rates in both retail and hospital sectors, driven by increasing demand and advancements in medical technology[1].

Competitive Landscape

The competitive landscape for antibiotics is dynamic, with new drugs and formulations entering the market. DAPZURA RT must compete with other antibiotics, and its market position will depend on its efficacy, safety profile, and pricing strategy.

"Biological products have been gaining market share, with the U.S. market showing a particularly high share compared to other regions"[4].

Key Takeaways

• Market Growth: The pharmaceutical market, including biological products like DAPZURA RT, has seen significant growth and is expected to continue this trend.
• Pricing Dynamics: The pricing of DAPZURA RT is influenced by broader market trends, with higher prices in regions like the U.S. contributing to substantial revenue.
• Regulatory Compliance: DAPZURA RT must adhere to FDA regulations and guidelines.
• Competitive Landscape: The drug competes in a dynamic market with other antibiotics, and its market position depends on its efficacy, safety, and pricing.

FAQs

What is DAPZURA RT used for?

DAPZURA RT is used for the treatment of certain bacterial infections, including complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections[2].

How is DAPZURA RT administered?

DAPZURA RT is administered intravenously, with dosage adjustments required for patients with renal impairment. For adult patients with CLCR less than 30 mL/min, the dosage is adjusted to 4 mg/kg or 6 mg/kg once every 48 hours[2].

What are the key market trends affecting DAPZURA RT?

Key market trends include the growth in sales revenues for biological products, higher prices in regions like the U.S., and the impact of consolidation on the pharmaceutical industry[1][4].

How does the pricing of DAPZURA RT compare to other regions?

The pricing of DAPZURA RT is higher in regions like the U.S. compared to other parts of the world, contributing to higher sales revenues in these markets[4].

What regulatory body oversees the approval and guidelines for DAPZURA RT?

The U.S. Food and Drug Administration (FDA) oversees the approval and guidelines for DAPZURA RT[5].

Sources

1. Canadian Trends in Estimated Pharmaceutical Drug Purchases and Spending - Canadian Journal of Health Technologies.
2. Dapzura RT Dosage Guide - Drugs.com.
3. Drug Industry: Profits, Research and Development, and Consolidation - U.S. Government Accountability Office.
4. International Market Size and Prices for Prescription Drugs - ASPE Issue Brief.
5. DAPZURA RT Prescribing Information - Medthority.