DELAFLOXACIN MEGLUMINE - Generic Drug Details

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

Delafloxacin meglumine is the generic ingredient in one branded drug marketed by Melinta and is included in two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Delafloxacin meglumine has one hundred and twenty-nine patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for DELAFLOXACIN MEGLUMINE

International Patents:	129
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	27
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DELAFLOXACIN MEGLUMINE
What excipients (inactive ingredients) are in DELAFLOXACIN MEGLUMINE?	DELAFLOXACIN MEGLUMINE excipients list
DailyMed Link:	DELAFLOXACIN MEGLUMINE at DailyMed

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

Constraining patent/regulatory exclusivity:

7,728,143

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

7,728,143

Dosage:

TABLET;ORAL

^*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.

Pharmacology for DELAFLOXACIN MEGLUMINE

Drug Class

Fluoroquinolone Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for DELAFLOXACIN MEGLUMINE

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DELAFLOXACIN MEGLUMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	12,036,219
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes	8,273,892			Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	8,273,892			Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes	8,969,569		Y

International Patents for DELAFLOXACIN MEGLUMINE

Country	Patent Number	Title	Estimated Expiration
Lithuania	C3214083
Japan	2015508846	アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法
South Korea	20150004797	ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME
South Korea	102237887
Russian Federation	2014136206	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
Portugal	3056492

Supplementary Protection Certificates for DELAFLOXACIN MEGLUMINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	C20210002 00366	Estonia		PRODUCT NAME: DELAFLOKSATSIIN;REG NO/DATE: EU/1/19/1393 19.12.2019
3214083	PA2021002,C3214083	Lithuania		PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083	LUC00196	Luxembourg		PRODUCT NAME: DELAFLOXACINE OU UN DE SES SELS OU ESTERS, Y COMPRIS LA MEGLUMINE DE DELAFLOXACINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1393 20191219
3214083	2190500-5	Sweden		PRODUCT NAME: DELAFLOXACIN IN FREE FORM OR IN PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER FORM, INCLUDING DELAFLOXACIN MEGLUMINE; REG. NO/DATE: EU/1/19/1393 20191219
3214083	PA2021002	Lithuania		PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083	301091	Netherlands		PRODUCT NAME: DELAFLOXACINE, OF EEN ZOUT OF ESTERS ERVAN, MET INBEGRIP VAN DELAFLOXACINE MEGLUMINE; REGISTRATION NO/DATE: EU/1/19/1393 20191219

DELAFLOXACIN MEGLUMINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Delafloxacin Meglumine

Introduction to Delafloxacin Meglumine

Delafloxacin meglumine, commonly known as Baxdela, is a fluoroquinolone antibacterial drug developed by Melinta Therapeutics. It has been approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the United States since June 2017[3][2].

Market Size and Growth Projections

The Delafloxacin Meglumine Market has experienced significant growth in recent years and is expected to continue expanding substantially through 2031. Market research reports predict substantial increases in market size, driven by the drug's efficacy and the rising demand for effective treatments against bacterial infections[1][4].

Market Segmentation

The market size is categorized based on type (purity ≥ 98%, purity ≥ 99%) and application (injection solution, tablet), as well as geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Market Dynamics

Key factors influencing the market dynamics include:

• Drivers: The increasing prevalence of antibiotic-resistant bacteria and the need for effective treatments drive the market.
• Restraints: Regulatory challenges and competition from other antibacterial drugs are significant restraints.
• Opportunities: Emerging markets and the development of new formulations present opportunities for growth.
• Challenges: High development costs and stringent regulatory requirements pose challenges to market participants[1][4].

Clinical Efficacy and Safety

Delafloxacin meglumine has demonstrated clinical efficacy in Phase 3 trials, showing non-inferiority to comparator drugs like vancomycin and aztreonam in treating ABSSSI. The drug's safety profile has been evaluated in various clinical studies, with a focus on adverse events and treatment emergent adverse reactions[2][5].

Regulatory Approval and Market Entry

The drug received approval from the FDA in June 2017, marking a significant milestone in its development. This approval has facilitated its entry into the market, enabling Melinta Therapeutics to establish a foothold in the antibacterial drug market[3][2].

Competitive Landscape

The Delafloxacin Meglumine Market is competitive, with several prominent companies such as Enbridge PharmTech, Poly Pharm, Chongqing Asincan Biotech, and Wallison Pharm contributing to the market. These companies are profiled in market research reports, which provide insights into their market shares, product portfolios, and growth prospects[4].

Financial Trajectory

The financial trajectory of the Delafloxacin Meglumine Market is optimistic, with projected significant expansion from 2023 to 2031. Market research reports provide detailed financial analyses, including revenue generated, cost assessment, and market shares held by key regions and companies. These reports help investors and stakeholders identify lucrative business strategies and opportunities for growth[1][4].

Manufacturing Processes and Supply Chain

The manufacturing processes for delafloxacin meglumine involve complex steps, including the synthesis of the active ingredient and the formulation of the final product. Market research reports provide insights into the manufacturing processes, rates of consumption and production, import/export status, product range, and supply chain assessment. This information is crucial for optimizing market opportunities and formulating effective business strategies[4].

Consumer Preferences and Market Data

The Delafloxacin Meglumine Market report offers accurate market insights into consumer preferences and behavior. It provides an overview of the market data and major companies, helping readers optimize on market opportunities and formulate lucrative business strategies. The report also includes a SWOT analysis of key market players to assess their strengths, weaknesses, opportunities, and threats[4].

Key Takeaways

1. Market Growth: The Delafloxacin Meglumine Market is expected to experience significant growth from 2023 to 2031.
2. Market Segmentation: The market is segmented by type (purity ≥ 98%, purity ≥ 99%) and application (injection solution, tablet).
3. Clinical Efficacy: Delafloxacin meglumine has demonstrated clinical efficacy in treating ABSSSI.
4. Regulatory Approval: The drug received FDA approval in June 2017.
5. Competitive Landscape: The market is competitive with several prominent companies contributing to it.
6. Financial Trajectory: The financial trajectory is optimistic with projected significant expansion.

FAQs

1. What is the current market size of the Delafloxacin Meglumine Market?

   • The market size is categorized based on type and application, and geographical regions. However, specific figures are not provided in the sources.

2. What are the key drivers of the Delafloxacin Meglumine Market?

   • The key drivers include the increasing prevalence of antibiotic-resistant bacteria and the need for effective treatments.

3. What are the challenges faced by the Delafloxacin Meglumine Market?

   • High development costs and stringent regulatory requirements are significant challenges.

4. Who are the prominent companies in the Delafloxacin Meglumine Market?

   • Prominent companies include Enbridge PharmTech, Poly Pharm, Chongqing Asincan Biotech, and Wallison Pharm.

5. What is the expected financial trajectory of the Delafloxacin Meglumine Market?

   • The financial trajectory is expected to be optimistic with projected significant expansion from 2023 to 2031.

Sources

1. Market Research Intellect - Delafloxacin Meglumine Market Report
2. FDA - Clinical Review of Delafloxacin Meglumine
3. PubMed - Delafloxacin: First Global Approval
4. Market Research Pulse - Delafloxacin Meglumine Market Trends and Outlook
5. Synapse - Delafloxacin Meglumine Drug Targets and Indications