BAXDELA Drug Patent Profile

When do Baxdela patents expire, and when can generic versions of Baxdela launch?

Baxdela is a drug marketed by Melinta and is included in two NDAs. There are fifteen patents protecting this drug.

This drug has one hundred and sixty-five patent family members in forty-one countries.

The generic ingredient in BAXDELA is delafloxacin meglumine. One supplier is listed for this compound. Additional details are available on the delafloxacin meglumine profile page.

DrugPatentWatch^® Generic Entry Outlook for Baxdela

Baxdela was eligible for patent challenges on June 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2031. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BAXDELA

International Patents:	165
US Patents:	15
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	77
Patent Applications:	387
Drug Prices:	Drug price information for BAXDELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BAXDELA
What excipients (inactive ingredients) are in BAXDELA?	BAXDELA excipients list
DailyMed Link:	BAXDELA at DailyMed

See drug prices for BAXDELA

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

Constraining patent/regulatory exclusivity:

7,728,143

NDA:

208611

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

7,728,143

NDA:

208610

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 BAXDELA

Drug Class

Fluoroquinolone Antibacterial

US Patents and Regulatory Information for BAXDELA

BAXDELA is protected by fifteen US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,728,143.

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	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	8,252,813		Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes	8,648,093		Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes	RE46617			Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	9,750,822		Y

International Patents for BAXDELA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006042034
Poland	3766876
China	102215690	Antimicrobial compositions
Mexico	353603	COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.)

Supplementary Protection Certificates for BAXDELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	132021000000011	Italy		PRODUCT NAME: DELAFLOXACINA O UN SUO SALE O ESTERE, INCLUSA LA DELAFLOXACINA MEGLUMINA(QUOFENIX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1393, 20191219
3214083	PA2021002,C3214083	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
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

Market Dynamics and Financial Trajectory for BAXDELA

Introduction

BAXDELA (delafloxacin) is a novel antibacterial drug developed by Melinta Therapeutics, LLC, and it has been making significant waves in the pharmaceutical market, particularly in the context of antibiotic resistance. Here, we will delve into the market dynamics and financial trajectory of BAXDELA.

Market Need and Drivers

The increasing challenge of antibiotic-resistant infections is a major driver for the growth of the antibiotic market, including drugs like BAXDELA. The misuse and overuse of antibiotics in humans, animals, and plants have accelerated the development of antibiotic-resistant bacteria, creating a pressing need for new and effective treatments[4].

Regulatory Approval and Commercialization

BAXDELA received FDA approval in 2017 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). This approval marked a significant milestone, as it introduced a new option for clinicians to combat resistant bacterial infections. In 2023, Melinta Therapeutics and Xediton Pharmaceuticals Inc. entered into an agreement for the commercialization and licensing of BAXDELA, among other anti-infective products, in Canada[4].

Sales Performance

The sales performance of BAXDELA has been influenced by several factors, including its comparative added clinical benefit and market demand. According to an analysis of antimicrobial drugs, drugs with higher overall comparative added clinical benefit scores tend to have higher early market sales. BAXDELA, being part of the antimicrobial cohort, has seen its sales reflect this trend. While the exact quarterly sales figures for BAXDELA are not provided in the sources, the overall sales of antimicrobial drugs in the first nine quarters post-launch have been significant, with average cumulative sales of $42 million for the highest-ranking drugs in this cohort[1].

Market Segmentation

The antibiotic resistance market is segmented by disease, with urinary tract infections, bloodstream infections, and hospital-acquired pneumonia being key areas. BAXDELA, with its indication for ABSSSI and CABP, fits into these segments. The urinary tract infection category had the highest revenue share in the antibiotic resistance market in 2023, indicating a strong market presence for drugs targeting similar infections[4].

Competitive Landscape

BAXDELA operates in a competitive landscape that includes other novel anti-infective products such as KIMYRSA (oritavancin), ORBACTIV (oritavancin), and VABOMERE (meropenem and vaborbactam). Companies like Melinta Therapeutics, Basilea Pharmaceutical Ltd, and Paratek Pharmaceuticals are key players in this market. The competitive dynamics are driven by the need for innovative therapies to combat antibiotic resistance, with each company vying for market share through strategic partnerships and licensing agreements[4].

Financial Performance

The financial performance of BAXDELA is closely tied to the overall financial health of its parent company, Melinta Therapeutics. In recent years, Melinta has seen growth in its revenue streams, partly due to the commercial success of its anti-infective products. For instance, the agreement with Xediton Pharmaceuticals for the commercialization of BAXDELA in Canada is expected to contribute to Melinta's revenue growth. While specific financial figures for BAXDELA are not detailed, the overall revenue growth of Melinta Therapeutics suggests a positive financial trajectory for the drug[4].

Regional Market Dynamics

North America is anticipated to dominate the global antibiotic resistance market, including the segment where BAXDELA operates. Factors such as strong healthcare infrastructure, government initiatives, and mandatory insurance policies that cover a significant portion of antibiotic prescriptions contribute to this dominance. In the U.S., for example, about 85% of antibiotics prescribed for infections are covered by insurance, which supports the market growth of drugs like BAXDELA[4].

Challenges and Limitations

Despite its potential, BAXDELA faces challenges such as the high development and approval costs associated with antimicrobial drugs. However, when considering the cost of failures and opportunity costs of capital, antimicrobial drugs like BAXDELA have lower expected capitalized development and approval costs compared to drugs in other cohorts, such as oncology[1].

Future Outlook

The future outlook for BAXDELA is promising, driven by the growing need for effective antibiotic treatments. The market is expected to grow at a CAGR of approximately 6% from 2024 to 2030, with innovative therapies and strategic partnerships playing crucial roles. Government initiatives and public health awareness campaigns aimed at reducing antibiotic misuse will also support the market growth of drugs like BAXDELA[4].

Key Takeaways

• Market Need: The increasing challenge of antibiotic-resistant infections drives the demand for drugs like BAXDELA.
• Regulatory Approval: BAXDELA received FDA approval in 2017 for ABSSSI and CABP.
• Sales Performance: BAXDELA's sales are influenced by its comparative added clinical benefit and market demand.
• Market Segmentation: BAXDELA targets segments like ABSSSI and CABP within the antibiotic resistance market.
• Competitive Landscape: BAXDELA competes with other novel anti-infective products in a dynamic market.
• Financial Performance: The drug's financial performance is tied to Melinta Therapeutics' overall revenue growth.
• Regional Dynamics: North America dominates the market due to strong healthcare infrastructure and insurance coverage.
• Challenges: High development costs, though lower compared to other drug cohorts.
• Future Outlook: The market is expected to grow at a CAGR of approximately 6% from 2024 to 2030.

FAQs

Q: What is BAXDELA used for? A: BAXDELA (delafloxacin) is used for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Q: Who developed BAXDELA? A: BAXDELA was developed by Melinta Therapeutics, LLC.

Q: What is the current market trend for antibiotic-resistant infections? A: The market is growing due to the increasing challenge of antibiotic-resistant infections, with a projected CAGR of approximately 6% from 2024 to 2030.

Q: How does BAXDELA compare to other antimicrobial drugs in terms of development costs? A: Despite high development costs, antimicrobial drugs like BAXDELA have lower expected capitalized development and approval costs compared to drugs in other cohorts, such as oncology.

Q: What are the key factors driving the growth of the antibiotic resistance market in North America? A: Strong healthcare infrastructure, government initiatives, and mandatory insurance policies that cover a significant portion of antibiotic prescriptions are key factors driving market growth in North America.

Sources

1. ASPE: Antimicrobial Drugs Market Returns Analysis Final Report[1].
2. Ligand Pharmaceuticals: Third Quarter 2023 Financial Results[2].
3. Business Wire: Ligand Reports First Quarter 2023 Financial Results[3].
4. GlobeNewswire: Global Antibiotic Resistance Market to Exhibit Growth at a CAGR of ~6% by 2030[4].

Last updated: 2024-12-16