DAPTOMYCIN - Generic Drug Details

What are the generic drug sources for daptomycin and what is the scope of freedom to operate?

Daptomycin is the generic ingredient in five branded drugs marketed by Cubist Pharms Llc, Accord Hlthcare, Aspiro, Be Pharms, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hangzhou Zhongmei, Hengrui Pharma, Hisun Pharm Hangzhou, Hospira, Meitheal, Mylan, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp, and is included in thirty-one NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Daptomycin has ninety-three patent family members in thirty-eight countries.

There are ten drug master file entries for daptomycin. Twenty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DAPTOMYCIN

International Patents:	93
US Patents:	7
Tradenames:	5
Applicants:	21
NDAs:	31
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	92
Patent Applications:	7,264
Drug Prices:	Drug price trends for DAPTOMYCIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAPTOMYCIN
What excipients (inactive ingredients) are in DAPTOMYCIN?	DAPTOMYCIN excipients list
DailyMed Link:	DAPTOMYCIN at DailyMed

See drug prices for DAPTOMYCIN

Recent Clinical Trials for DAPTOMYCIN

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

Sponsor	Phase
Chang Gung Memorial Hospital	N/A
Pfizer	Phase 2
University Magna Graecia	Phase 4

See all DAPTOMYCIN clinical trials

Generic filers with tentative approvals for DAPTOMYCIN

Applicant	Application No.	Strength	Dosage Form
		350MG/VIAL	POWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DAPTOMYCIN

Drug Class

Lipopeptide Antibacterial

Medical Subject Heading (MeSH) Categories for DAPTOMYCIN

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for DAPTOMYCIN

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DAPTOMYCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CUBICIN RF	For Injection	daptomycin	500 mg/vial	021572	1	2008-11-19

US Patents and Regulatory Information for DAPTOMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	206077-001	Apr 11, 2018	AP	RX	No	No
Fresenius Kabi Usa	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213396-001	Aug 1, 2024	AP	RX	No	No
Accord Hlthcare	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	212667-001	Jul 12, 2019	AP	RX	No	No
Hospira	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	210282-001	Jun 21, 2021		RX	Yes	Yes			Y
Eugia Pharma	DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213171-001	Sep 2, 2021	AP	RX	No	No

Expired US Patents for DAPTOMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003

EU/EMA Drug Approvals for DAPTOMYCIN

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 DAPTOMYCIN

Country	Patent Number	Title	Estimated Expiration
Taiwan	I606838
Spain	2552754
Japan	2017075186	リポペプチド組成物および関連する方法 (LIPOPEPTIDE COMPOSITION AND RELATED METHOD)
World Intellectual Property Organization (WIPO)	2006130629
Japan	2013511557

Supplementary Protection Certificates for DAPTOMYCIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1115417	SZ 22/2006	Austria		PRODUCT NAME: DAPTOMYCIN
1115417	22/2006	Austria		PRODUCT NAME: DAPTOMYCIN; REGISTRATION NO/DATE: EU/1/05/328/001 UND 002 20060119
1115417	CA 2006 00018	Denmark		PRODUCT NAME: DAPTOMYCIN
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	06C0022	France		PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119

DAPTOMYCIN Market Analysis and Financial Projection Experimental

Daptomycin Market Dynamics and Financial Trajectory

Introduction to Daptomycin

Daptomycin is a cyclic lipopeptide antibiotic derived from the organism Streptomyces roseosporus. It is primarily used to treat complex skin and skin structure infections, as well as certain bloodstream infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)[1][3][5].

Market Size and Growth Projections

The global Daptomycin market is anticipated to experience significant growth over the coming years. Here are some key projections:

• By 2030, the market is expected to reach USD 3.90 billion, growing at a CAGR of 3.9%[1].
• Another forecast suggests the market will reach USD 5,509.53 million by 2028, with a CAGR of 4.27% from 2021 to 2028[3][4].
• A more long-term projection indicates the market size will expand to USD 6.36 billion by 2033, growing at a CAGR of 4.01% from 2023 to 2033[5].

Market Drivers

Several factors are driving the growth of the Daptomycin market:

• Increasing Prevalence of Antibiotic-Resistant Infections: The rise in drug-resistant bacteria has created a significant need for alternative treatment options, with Daptomycin being highly effective against these resistant strains[2][3][5].
• Growing Healthcare Expenditure: Governments and healthcare organizations worldwide are investing heavily in combating infectious diseases, leading to increased spending on antibiotics like Daptomycin[2][5].
• Advancements in Drug Delivery Systems: Innovations in drug delivery methods have improved the administration of Daptomycin, enhancing patient convenience and compliance[2].
• Strong Pipeline of New Formulations: Pharmaceutical companies are actively developing novel formulations and combination therapies to expand the market reach of Daptomycin[2][3].
• Rising Awareness and Geriatric Population: Increasing awareness about the benefits of Daptomycin and the growing geriatric population susceptible to infections are also driving market growth[2][5].

Market Restraints

Despite the positive growth trajectory, there are several challenges facing the Daptomycin market:

• High Cost of Therapy: The high cost of Daptomycin therapy compared to traditional antibiotics is a significant restraint[2][5].
• Side Effects and Limitations: Potential side effects and limitations associated with the drug can impact its adoption[2][5].
• Stringent Regulatory Requirements: The stringent regulatory requirements for drug approval can slow down market growth[2][5].
• Limited Availability: Limited availability of Daptomycin in certain regions is another restraint[2].

Market Opportunities

There are several opportunities that could further boost the growth of the Daptomycin market:

• Untapped Potential in Emerging Economies: There is significant untapped potential in emerging economies where healthcare infrastructure is improving[2][5].
• Development of Combination Therapies: Collaborations for combination therapies to improve treatment outcomes are expected to create new opportunities[2][5].
• Increasing Focus on Antimicrobial Stewardship: Initiatives and guidelines by governments and healthcare organizations to combat antibiotic resistance support the use of effective antibiotics like Daptomycin[5].

Regional Analysis

The Daptomycin market is geographically diverse, with different regions contributing to its growth:

• North America: Dominates the market due to a well-established healthcare system and high awareness of antibiotic resistance. The U.S. is a key player in this region[3][5].
• Europe: Holds the second largest position, driven by rising cases of MRSA and expanded marketing authorizations for Daptomycin[3].
• Asia-Pacific: Expected to grow at the highest rate due to increasing healthcare expenditure, improving healthcare infrastructure, and the growing prevalence of hospital-acquired infections and antibiotic resistance[3][5].

Competitive Landscape

The Daptomycin market is characterized by intense competition among several pharmaceutical companies. Key players are focusing on:

• Product Innovation: Developing novel formulations and combination therapies to enhance market reach[2][5].
• Strategic Collaborations: Partnerships with healthcare providers, research institutions, and regulatory authorities to expand market presence[2].
• Geographical Expansion: Expanding into emerging economies to tap into new markets[2][5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the Daptomycin market:

• Increased Demand: The emergence of secondary bacterial infections among hospitalized COVID-19 patients has increased the demand for Daptomycin[2][5].
• Supply Chain Disruptions: Disruptions in the pharmaceutical supply chain and restrictions on healthcare services have impacted the availability and distribution of Daptomycin[2][5].

SWOT Analysis

Strengths

• Efficacy Against Antibiotic-Resistant Bacteria: Daptomycin’s effectiveness against drug-resistant bacteria is a significant strength[2][5].
• Strong Research and Development Capabilities: Market players have robust R&D capabilities, leading to continuous innovation[2][5].

Weaknesses

• High Cost and Potential Side Effects: The high cost and potential side effects of Daptomycin therapy are notable weaknesses[2][5].
• Regulatory Challenges: Stringent regulatory requirements for drug approval can be a barrier[2][5].

Opportunities

• Untapped Markets: Emerging economies offer significant untapped potential[2][5].
• Combination Therapies: Development of combination therapies to enhance treatment outcomes[2][5].

Threats

• Intense Competition: Competition from existing antibiotics and alternative treatment options is a threat[2][5].
• Patent Expirations: The entry of generic products following patent expirations could impact market dynamics[2].

Key Takeaways

• The Daptomycin market is expected to grow significantly due to the rising prevalence of antibiotic-resistant infections.
• Advancements in drug delivery systems, growing healthcare expenditure, and a strong pipeline of new formulations are key drivers.
• High costs, side effects, and regulatory challenges are significant restraints.
• Emerging economies and the development of combination therapies offer substantial opportunities.
• The market is highly competitive, with a focus on product innovation and geographical expansion.

FAQs

Q: What is Daptomycin used for? A: Daptomycin is used to treat complex skin and skin structure infections, as well as certain bloodstream infections caused by gram-positive bacteria, including MRSA[1][3][5].

Q: What is the projected market size of the Daptomycin market by 2030? A: The market is expected to reach USD 3.90 billion by 2030, growing at a CAGR of 3.9%[1].

Q: What are the main drivers of the Daptomycin market? A: The main drivers include the increasing prevalence of antibiotic-resistant infections, growing healthcare expenditure, advancements in drug delivery systems, and a strong pipeline of new formulations[2][3][5].

Q: What are the significant restraints facing the Daptomycin market? A: High cost of therapy, potential side effects, stringent regulatory requirements, and limited availability in certain regions are significant restraints[2][5].

Q: Which region is expected to grow at the highest rate in the Daptomycin market? A: The Asia-Pacific region is expected to grow at the highest rate due to increasing healthcare expenditure and the growing prevalence of hospital-acquired infections and antibiotic resistance[3][5].

Cited Sources

1. Market Research Future: "Daptomycin Market Size Worth USD 3.90 Billion by 2030 at 3.9% CAGR".
2. MarkWide Research: "Daptomycin market 2024-2032 | Size, Share, Growth".
3. Data Bridge Market Research: "Global Daptomycin Market – Industry Trends and Forecast to 2028".
4. OpenPR: "Daptomycin Market to account to USD 5,509.53 million by 2028".
5. Evolve Business Intelligence: "Daptomycin Market Analysis and Global Forecast 2023-2033".