FIRVANQ KIT Drug Patent Profile

Which patents cover Firvanq Kit, and what generic alternatives are available?

Firvanq Kit is a drug marketed by Azurity and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in seven countries.

The generic ingredient in FIRVANQ KIT is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Firvanq Kit

A generic version of FIRVANQ KIT was approved as vancomycin hydrochloride by FRESENIUS KABI USA on March 17^th, 1987.

Summary for FIRVANQ KIT

International Patents:	9
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FIRVANQ KIT
DailyMed Link:	FIRVANQ KIT at DailyMed

Recent Clinical Trials for FIRVANQ KIT

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

Sponsor	Phase
Centenary Institute of Cancer Medicine and Cell Biology	Phase 4
South Australian Health and Medical Research Institute	Phase 4
Royal Adelaide Hospital	Phase 4

See all FIRVANQ KIT clinical trials

Paragraph IV (Patent) Challenges for FIRVANQ KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRVANQ KIT	For Oral Solution	vancomycin hydrochloride	25 mg/mL and 50 mg/mL	208910	1	2020-05-18

US Patents and Regulatory Information for FIRVANQ KIT

FIRVANQ KIT is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes			Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes			Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes			Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes			Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes			Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes			Y

International Patents for FIRVANQ KIT

See the table below for patents covering FIRVANQ KIT around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3145527
China	106573037
European Patent Office	3145527	COMPOSITION DE VANCOMYCINE ORALE LIQUIDE ET PROCÉDÉ ASSOCIÉ (COMPOSITION AND METHOD FOR VANCOMYCIN ORAL LIQUID)
Canada	2941867
European Patent Office	4000628
Australia	2015229069	Composition and method for vancomycin oral liquid

FIRVANQ KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FIRVANQ Kit

Introduction to FIRVANQ Kit

FIRVANQ, an oral vancomycin hydrochloride solution, is a significant player in the treatment of Clostridium difficile-associated diarrhea (CDAD) and Staphylococcus aureus colitis. Developed and marketed by Azurity Pharmaceuticals, Inc., FIRVANQ has been FDA-approved since 2018, replacing CutisPharma's FIRST®-Vancomycin Unit-of-Use Compounding Kit[1][2].

Market Size and Growth

The global vancomycin market, within which FIRVANQ operates, is projected to grow substantially. As of 2020, the vancomycin market was valued at US$ 313.7 million and is expected to reach US$ 465.1 million by 2027, growing at a Compound Annual Growth Rate (CAGR) of 5.8% from 2021 to 2027[4].

Regional Market Dynamics

United States

The U.S. vancomycin market is particularly promising, valued at US$ 84.5 million in 2020 and expected to rise at a high CAGR. The presence of prominent manufacturers, advanced healthcare facilities, and high consumer healthcare spending drive this growth. The U.S. is anticipated to dominate the market due to its well-established healthcare infrastructure and early adoption of innovative treatments[4].

China

China is another key region, with the vancomycin market projected to reach US$ 102.3 million by 2027, growing at a CAGR of 9.4%. Government initiatives for infection control, a growing population, and increased healthcare awareness are driving this expansion[4].

Competitive Landscape

FIRVANQ operates in a competitive market with several other vancomycin products. However, its FDA approval and specific formulation set it apart. Azurity Pharmaceuticals has taken legal action against pharmacy outsourcing facilities, such as Edge Pharma, for allegedly manufacturing and selling vancomycin solutions that are nearly identical to FIRVANQ, highlighting the competitive and regulatory challenges in this market[2].

Regulatory Environment

The regulatory landscape is crucial for FIRVANQ. Azurity's lawsuit against Edge Pharma underscores the importance of compliance with FDA regulations, particularly the bulk manufacturing guidelines for outsourcing facilities under 21 U.S.C. § 503B. Ensuring compliance is vital for maintaining market integrity and consumer trust[2].

Product Features and Benefits

FIRVANQ is designed to be easy to use and cost-effective compared to existing vancomycin therapies. It is available in 25 mg/mL and 50 mg/mL strengths in convenient 150 mL and 300 mL sizes, making it a preferred option for pharmacists and patients alike[1].

Recall and Safety Concerns

In 2021, Azurity Pharmaceuticals voluntarily recalled one lot of FIRVANQ kits due to the incorrect diluent solution, which could lead to doses above or below the recommended levels. This recall highlights the importance of quality control and the potential risks associated with incorrect dosing, particularly for vulnerable patient groups such as the elderly and immunocompromised individuals[5].

Financial Impact

The financial trajectory of FIRVANQ is influenced by several factors, including market growth, competition, and regulatory compliance. The recall, although not resulting in reported adverse events, could have short-term financial implications due to the costs associated with the recall and potential loss of consumer confidence. However, the overall market growth and the product's unique positioning are likely to support its long-term financial performance.

Market Trends and Drivers

• Increasing Demand for Vancomycin: The rising incidence of antibiotic-resistant infections, particularly CDAD and Staphylococcus aureus infections, drives the demand for effective treatments like FIRVANQ[4].
• Innovative Treatments: The rapid deployment of innovative treatments in the U.S. and other regions fuels market expansion[4].
• Government Initiatives: Government initiatives for infection control, especially in regions like China, contribute to market growth[4].

Challenges and Opportunities

• Regulatory Compliance: Ensuring compliance with FDA regulations is a significant challenge but also an opportunity to differentiate FIRVANQ from competitors[2].
• Quality Control: Maintaining high-quality standards is crucial to avoid recalls and ensure patient safety, which can also enhance the product's reputation and market share[5].
• Market Expansion: The growing vancomycin market in regions like the U.S. and China presents opportunities for FIRVANQ to expand its market presence and revenue.

Key Takeaways

• FIRVANQ operates in a growing global vancomycin market projected to reach US$ 465.1 million by 2027.
• The product's FDA approval and specific formulation differentiate it in the market.
• Regulatory compliance and quality control are critical for maintaining market integrity and consumer trust.
• Market trends, including increasing demand for vancomycin and government initiatives for infection control, drive the product's financial trajectory.

Frequently Asked Questions (FAQs)

Q: What is FIRVANQ used for? A: FIRVANQ is used to treat patients with Clostridium difficile-associated diarrhea (CDAD) and Enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains[1].

Q: What was the reason for the FIRVANQ recall in 2021? A: The recall was due to the incorrect diluent solution in some kits, which could lead to doses above or below the recommended levels[5].

Q: How does FIRVANQ differentiate itself in the market? A: FIRVANQ is FDA-approved, easy to use, and cost-effective compared to existing vancomycin therapies. It is available in convenient strengths and sizes[1].

Q: What are the key regions driving the growth of the vancomycin market? A: The United States and China are key regions driving the growth of the vancomycin market due to factors such as advanced healthcare infrastructure, high consumer healthcare spending, and government initiatives for infection control[4].

Q: What are the potential risks associated with incorrect dosing of FIRVANQ? A: Incorrect dosing of FIRVANQ can lead to persistent diarrhea, dehydration, electrolyte abnormalities, recurrence of C. difficile infection, severe colitis, colon perforation, and potentially death, especially in vulnerable patient groups[5].

Sources Cited:

1. CutisPharma Announces FDA Approval Of FIRVANQ™ For Treatment Of Clostridium difficile-associated Diarrhea (CDAD) And Staphylococcus aureus Colitis - PR Newswire.
2. Pioneer Drug Maker Throws First Punch at Pharmacy Outsourcing Facilities (503Bs) - Troutman.
3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee - Oregon P&T Committee.
4. Vancomycin Market Size, Share Global Trajectory - 2027 - Fact.MR.
5. FDA is Recalling One Lot of Firvanq - Managed Healthcare Executive.