Vancomycin hydrochloride - Generic Drug Details

What are the generic sources for vancomycin hydrochloride and what is the scope of freedom to operate?

Vancomycin hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Azurity, Lederle, Alkem Labs Ltd, Amneal, Steriscience Speclts, Hikma, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Pharmacia And Upjohn, Samson Medcl, Zhejiang Novus Pharm, and Baxter Hlthcare, and is included in sixty-three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vancomycin hydrochloride has fifty-six patent family members in twenty-nine countries.

There are twenty drug master file entries for vancomycin hydrochloride. Thirty suppliers are listed for this compound.

Summary for vancomycin hydrochloride

International Patents:	56
US Patents:	12
Tradenames:	6
Applicants:	34
NDAs:	63
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	429
Patent Applications:	1,997
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vancomycin hydrochloride
What excipients (inactive ingredients) are in vancomycin hydrochloride?	vancomycin hydrochloride excipients list
DailyMed Link:	vancomycin hydrochloride at DailyMed

Recent Clinical Trials for vancomycin hydrochloride

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

Sponsor	Phase
Chang Gung Memorial Hospital	N/A
Hospital Universitario Evangelico de Curitiba	Phase 3
University of Duhok	N/A

See all vancomycin hydrochloride clinical trials

Pharmacology for vancomycin hydrochloride

Drug Class

Glycopeptide Antibacterial

Medical Subject Heading (MeSH) Categories for vancomycin hydrochloride

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for vancomycin hydrochloride

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for VANCOMYCIN HYDROCHLORIDE

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 vancomycin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	206243-001	Dec 23, 2015		DISCN	No	No
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-001	Feb 15, 2019		RX	Yes	Yes	10,039,804		Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes	10,959,947		Y
Mylan Labs Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	POWDER;INTRAVENOUS	209481-001	Jul 10, 2018		DISCN	Yes	No
Meitheal	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	215197-001	Jul 28, 2022	AP	RX	No	No
Hospira	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	062912-002	Jan 7, 2009	AP	RX	No	No
Gland Pharma Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	205694-002	Jan 21, 2016	AP	RX	No	No

International Patents for vancomycin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	035368	КОМПОЗИЦИИ ГЛИКОПЕПТИДОВ (GLYCOPEPTIDE COMPOSITIONS)
China	106573037	用于万古霉素口服液的组合物和方法 (Composition and method for vancomycin oral liquid)
European Patent Office	4000628
Denmark	3542812
Denmark	3215173
Poland	3215173
Croatia	P20200101

Vancomycin hydrochloride Market Analysis and Financial Projection Experimental

Vancomycin Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

Vancomycin hydrochloride, a glycopeptide antibiotic, is crucial in treating infections caused by methicillin-resistant Staphylococcus aureus (MRSA), including skin infections, sepsis, endocarditis, bone and joint infections, and meningitis. Here’s a detailed look at the market dynamics and financial trajectory of vancomycin hydrochloride.

Global Market Size and Growth

The global vancomycin market is projected to grow significantly over the forecast period. As of 2020, the market was valued at US$ 313.7 million, and it is expected to reach US$ 465.1 million by 2027, expanding at a Compound Annual Growth Rate (CAGR) of 5.8% from 2021 to 2027[1][4].

Regional Market Insights

North America

North America is anticipated to hold a significant share of the global vancomycin market. The region's growth is driven by the rising incidence of vancomycin-resistant Staphylococcus aureus (VRSA) infections, increased R&D initiatives, and a well-developed healthcare sector. The U.S. vancomycin market, in particular, was valued at US$ 84.5 million in 2020 and is expected to rise at the highest CAGR over the forecast period due to early adoption of innovative treatments and robust healthcare infrastructure[1][4].

China

China is another key market, projected to reach a valuation of US$ 102.3 million by 2027, growing at a CAGR of 9.4% from 2021 to 2027. This growth is attributed to a rising population, increased healthcare awareness, and government initiatives for infection control[1][4].

Europe

In Europe, countries like Germany and Canada are also expected to contribute to the market growth. Germany's vancomycin market is projected to rise at a CAGR of 4%, while Canada's market is expected to record a CAGR of 4.6% over the forecast period[4].

Type and Application Insights

Type

The linezolid segment is expected to occupy a significant share of the global vancomycin market. Linezolid, an oxazolidinone antibiotic, is used to treat infections such as pneumonia and skin diseases, and its broad spectrum of activity against gram-positive bacteria drives its demand[1].

Application

Vancomycin is used to treat a variety of infections, including sepsis, lung infections, skin and soft tissue infections, colitis and intestinal inflammation, and other infections. The increasing incidence of these infections and the need for effective treatments are key drivers of the market[4].

Cost and Pricing Analysis

The cost of vancomycin can vary based on several factors, including the treatment plan, insurance coverage, and the pharmacy used. For instance, the cost of vancomycin IV infusion, which is approved to treat serious MRSA infections, depends on these variables. Patients with insurance may pay differently compared to those without insurance, with factors such as prior authorization and specific plan benefits influencing the cost[2].

Competitive Landscape

The vancomycin market is competitive, with several key players investing in research and development to secure regulatory approvals for new products. These companies are also focusing on expanding their market position across different geographies. For example, research initiatives like those at Rutgers University, which identified genes making illnesses resistant to therapy, highlight the ongoing efforts to improve treatment options[4].

Government Initiatives and Awareness

Government and non-government initiatives play a crucial role in driving the vancomycin market. Awareness campaigns about the importance of infection control and the development of novel drugs and treatments are supporting market growth. Additionally, government support for pharmaceutical manufacturers in countries like China is fostering market expansion[1][4].

Challenges and Opportunities

Challenges

Despite the growth prospects, the vancomycin market faces challenges such as the development of antibiotic resistance and the high costs associated with drug development. The study by ASPE highlights that antimicrobial drugs, including vancomycin, have average to high development and approval costs, although they are lower compared to oncology drugs[3].

Opportunities

The increasing prevalence of infectious diseases and the need for effective treatments present significant opportunities for the vancomycin market. The market is also driven by the rising demand for antibiotics and the growing awareness about various treatments for infectious illnesses. Innovations in diagnostic techniques and research on combination medicines further enhance market demand[1][4].

Adverse Reactions and Safety Concerns

Vancomycin, like any other medication, comes with potential adverse reactions. These include reversible neutropenia, which has been reported in patients receiving prolonged therapy or high dosages. Other safety concerns, such as hemorrhagic occlusive retinal vasculitis associated with intracameral or intravitreal administration, highlight the need for careful monitoring and administration of the drug[5].

Key Takeaways

• Global Market Growth: The global vancomycin market is expected to reach US$ 465.1 million by 2027, growing at a CAGR of 5.8%.
• Regional Dominance: North America, particularly the U.S., and China are expected to be key markets.
• Type and Application: Linezolid and various infection treatments drive market demand.
• Cost and Pricing: Costs vary based on treatment plans, insurance, and pharmacies.
• Competitive Landscape: Key players are investing in R&D and regulatory approvals.
• Government Initiatives: Awareness campaigns and government support are crucial for market growth.

FAQs

1. What is the projected global market size for vancomycin by 2027?

The global vancomycin market is expected to reach US$ 465.1 million by 2027[1][4].

2. Which region is expected to dominate the vancomycin market?

North America, particularly the U.S., is expected to dominate the market due to rising VRSA infections and advanced healthcare infrastructure[1][4].

3. What factors affect the cost of vancomycin?

The cost of vancomycin is influenced by the treatment plan, insurance coverage, pharmacy used, and specific plan benefits[2].

4. What are the common applications of vancomycin?

Vancomycin is used to treat sepsis, lung infections, skin and soft tissue infections, colitis and intestinal inflammation, and other infections[4].

5. Are there any safety concerns associated with vancomycin?

Yes, vancomycin can cause reversible neutropenia and other adverse reactions such as hemorrhagic occlusive retinal vasculitis in certain administration routes[5].

Cited Sources

1. Fact.MR: Vancomycin Market Size, Share Global Trajectory - 2027[1]
2. MedicalNewsToday: Vancomycin cost 2024: Coupons and more[2]
3. ASPE: Antimicrobial Drugs Market Returns Analysis[3]
4. BioSpace: Vancomycin Market to Expand around 1.5X by 2027: Fact.MR Research[4]
5. Baxter PI: Vancomycin Injection[5]