Last Updated: May 10, 2026

VANCOMYCIN HYDROCHLORIDE Drug Patent Profile


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When do Vancomycin Hydrochloride patents expire, and what generic alternatives are available?

Vancomycin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Eurofarma, Gland, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Plano Pharms, Sagent Pharms, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Samson Medcl, Steriscience, Zhejiang Novus Pharm, and Baxter Hlthcare. and is included in fifty-four NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Vancomycin Hydrochloride

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

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  • What is the 5 year forecast for VANCOMYCIN HYDROCHLORIDE?
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Recent Clinical Trials for VANCOMYCIN HYDROCHLORIDE

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

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentrePHASE3
The Methodist Hospital Research InstituteNA
Nantes University HospitalPHASE2

See all VANCOMYCIN HYDROCHLORIDE clinical trials

Pharmacology for VANCOMYCIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for VANCOMYCIN HYDROCHLORIDE
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
Plano Pharms VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 090250-001 Apr 27, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Mylan Labs Ltd VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride POWDER;INTRAVENOUS 209481-002 Jul 10, 2018 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 204360-002 Oct 15, 2018 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062663-005 Aug 17, 2016 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Xellia Pharms Aps VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 204125-002 Dec 28, 2015 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Vancomycin Hydrochloride

Last updated: April 24, 2026

Vancomycin hydrochloride is a mature, off-patent antibiotic active ingredient sold globally as both branded and generic products. Its market dynamics are driven by (1) hospital-centric demand for serious Gram-positive infections, (2) periodic supply and quality shocks that tighten availability, and (3) generic price pressure that compresses margins over time. Financial trajectory since the mid-2010s has been characterized by stable-to-modest revenue growth in aggregate units offset by declining price per dose, with spikes linked to procurement cycles, substitution patterns, and acute supply disruptions.

What is vancomycin hydrochloride’s demand engine in pharma?

Where the drug is used

Vancomycin is a hospital-use antibiotic for serious infections caused by susceptible Gram-positive pathogens, most notably Staphylococcus aureus (including MRSA) and coagulase-negative staphylococci, and it is used in:

  • Inpatient treatment of severe skin/soft tissue and bloodstream infections
  • Surgical prophylaxis in select high-risk settings
  • Osteomyelitis and endocarditis regimens
  • Empiric therapy pathways when resistance patterns or patient risk profiles warrant it

Why demand is sticky

Demand stays relatively stable because:

  • It is embedded in hospital treatment algorithms for MRSA and severe Gram-positive disease.
  • It is used in recurring inpatient cohorts rather than elective outpatient cycles.
  • Substitution is constrained by clinical familiarity, dosing protocols, monitoring requirements, and payer coverage for hospital formularies (when generics are available).

How does the competitive landscape shape market pricing and margins?

Generic dominance

Vancomycin hydrochloride is widely generic. Competitive pressure typically manifests as:

  • Price compression after major patent expiries and at launch of additional ANDA entrants
  • Tender-driven purchasing, with procurement price benchmarking across suppliers
  • Margin squeeze at the distributor and manufacturer level when supply normalizes

Branded-to-generic switching

Branded products persist mainly where:

  • Hospitals run brand-preference formularies
  • Product availability or packaging format makes substitution slower
  • Specific NDCs or concentrations are held in purchasing agreements

Pipeline threat profile

Vancomycin is a first-line old antibiotic. Financial trajectory depends less on “next-gen” clinical launches and more on:

  • Capacity additions at generic manufacturers
  • Compliance-driven supply availability
  • Substitution by alternative agents during shortages (and then rebound when vancomycin supply stabilizes)

What market dynamics most affect revenue in year-to-year cycles?

1) Supply availability and manufacturing quality

Vancomycin markets repeatedly face episodic tightness due to:

  • Raw material and sterile fill-finish constraints
  • Batch-release timing and quality system remediation
  • Regulatory actions that can temporarily restrict specific lots or sites

Financial effect: revenue can show step changes during shortages (higher pricing power, accelerated purchase orders) and then revert with normalization.

2) Hospital purchasing and tender structures

Hospitals increasingly buy via:

  • Group purchasing organization tenders
  • Contracted bid cycles with fixed term discounts
  • Concentration- and packaging-specific procurement requirements

Financial effect: volume can remain steady while ASP swings down and up around contract award dates.

3) Utilization changes and resistance epidemiology

Vancomycin use intensity depends on:

  • MRSA incidence trends
  • Stewardship programs altering empiric therapy patterns
  • Shifts toward or away from comparator agents with different susceptibility profiles

Financial effect: modest utilization drift can offset price declines in some periods, but in a mature generic market price usually dominates.

How has the market value and financial trajectory evolved recently?

Vancomycin hydrochloride is typically reported as part of the broader vancomycin therapeutic class and as a segment of the inpatient antibiotic spend pool. For financial trajectory analysis, the most consistent pattern across mature generics is:

  • Revenue stability or modest growth from steady unit demand and periodic tender fluctuations
  • Declining or flat price per unit (ASP) as more generic entrants compete
  • Volatility around supply events, which can lift realized price and shipment volumes temporarily

Observable drivers in the financial line

  1. Unit volume: sustained because the drug remains standard-of-care for serious Gram-positive infections in many formularies.
  2. Realized pricing: tends to trend down over multi-year horizons due to generic competition.
  3. Gross margin: typically pressured by commodity-like pricing and manufacturing compliance costs; can temporarily improve during constrained supply.
  4. Working capital and inventory: can become significant during shortage periods as providers pre-book supplies, affecting distributor and manufacturer revenue recognition timing.

What do procurement and regulatory events imply for near-term forecasting?

Short-run sensitivity

Forecasting over a 6–18 month horizon should weigh:

  • Release stability across active manufacturing sites
  • Any site-level remediation actions that can shrink effective capacity
  • Contract renewal timing that can shift volumes to lowest-bid suppliers

Medium-term sensitivity

Over 2–5 years, trajectory is mainly influenced by:

  • Continued generic price compression
  • Capacity rationalization (some low-cost suppliers exit or consolidate)
  • Continued stewardship-driven dosing optimization that can shift total mg exposure without altering prescriptions materially

How should investors and planners interpret “financial trajectory” for a mature generic?

In vancomycin hydrochloride, “financial trajectory” is best read as the interaction of:

  • Volume resilience (hospital necessity)
  • Price erosion (generic commoditization)
  • Supply-led volatility (capacity, batch release, and compliance)

This creates a profile where revenue often tracks unit demand and procurement cycles more closely than innovation-led growth. The absence of patent-based exclusivity means upside typically emerges from supply constraints rather than product differentiation.

What is the market structure by manufacturer and channel?

Channel mix

Vancomycin hydrochloride reaches hospitals through:

  • Hospital pharmacy procurement (direct contracting)
  • Wholesalers distributing multiple generic SKUs
  • Group purchasing organizations (GPOs) influencing tender outcomes

Seller economics

Generic manufacturer economics generally depend on:

  • Sterile manufacturing cost efficiency
  • Batch throughput and yield
  • Quality and regulatory readiness to avoid lot rejection
  • Ability to supply contracted quantities at tender price points

What are the key watch-items that move money in vancomycin hydrochloride?

  • Tender award timing and contract pricing resets across major hospital systems
  • Supply tightness signals from wholesalers and pharmacy procurement desks
  • Concentration and vial format shifts that can alter unit conversion even when mg demand stays similar
  • Regulatory actions affecting manufacturing sites or specific lots
  • Alternate antibiotic substitution during shortages that can create rebound demand post-stability

Market scenario read-through (base case mechanics)

In a typical mature generic cycle for vancomycin hydrochloride:

  • If supply is stable, pricing continues to drift downward and revenue growth slows.
  • If supply tightness occurs, price and shipments can rise temporarily, with short-lived margin expansion.
  • If quality issues reduce effective supply, the market can experience both short-term revenue upside for available suppliers and longer-term volume volatility as hospitals switch to alternatives.

Key Takeaways

  • Vancomycin hydrochloride has sticky hospital demand for serious Gram-positive infections, which supports unit volume resilience.
  • Its financial trajectory is dominated by generic market forces, with long-run price compression and margin pressure once supply normalizes.
  • The biggest revenue swings come from supply availability and tender-driven purchasing cycles, not from innovation-led growth.
  • Near-term forecasting should focus on manufacturing site stability, batch release continuity, and contract award timing.

FAQs

1) Is vancomycin hydrochloride primarily an inpatient market?

Yes. Demand is primarily driven by hospital settings, where treatment protocols for serious Gram-positive infections require intravenous vancomycin and where purchasing is structured through contracts, tenders, and wholesalers.

2) What typically drives revenue changes for a mature generic antibiotic?

Revenue changes usually track three factors: (1) supply availability and batch-release continuity, (2) hospital contract and tender pricing resets, and (3) utilization shifts tied to epidemiology and stewardship.

3) Does vancomycin face major patent-style exclusivity dynamics?

Vancomycin hydrochloride is largely off-patent in practice, so market performance is more exposed to generic entry and pricing competition than to exclusivity cliffs.

4) Why can financial results spike despite commoditization?

Shortages or site-level disruptions can tighten supply, increase realized pricing, and accelerate orders. Those spikes typically fade when capacity returns and competitive pricing reasserts.

5) What is the best way to model vancomycin financials?

Model as a mature generic: stable unit base plus procurement-cycle ASP drift, with volatility overlays from supply constraints and quality/regulatory events.


References

[1] FDA. “Drug Shortages.” U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
[2] WHO. “Critically important antimicrobials for human medicine.” World Health Organization. https://www.who.int/publications/i/item/9789241515528
[3] Lexicomp / Clinical pharmacology resources (vancomycin indications and administration guidance). Wolters Kluwer. https://www.wolterskluwer.com/en/solutions/lexicomp
[4] MedlinePlus. “Vancomycin.” U.S. National Library of Medicine. https://medlineplus.gov/druginfo/meds/a682063.html
[5] PubChem. “Vancomycin Hydrochloride.” U.S. National Library of Medicine. https://pubchem.ncbi.nlm.nih.gov/

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