DUROLANE®

About DUROLANE® — Single-Injection NASHA Viscosupplementation

DUROLANE® is a stabilized hyaluronic acid medical device used in viscosupplementation for osteoarthritic joints. It contains highly purified, non-animal-derived sodium hyaluronate produced by bacterial fermentation and cross-linked with NASHA (non-animal-stabilized hyaluronic acid) technology. The US Instructions for Use describe DUROLANE® as a clear, transparent, viscous gel suspended in phosphate-buffered saline at a concentration of 20 mg/mL. Hyaluronic acid is naturally present in synovial fluid, where it contributes to joint lubrication and cushioning; in osteoarthritis, the quality and function of that fluid may decline, and viscosupplementation is used to help restore the joint’s lubricating and shock-absorbing properties. [1][4]

NASHA technology stabilizes naturally entangled hyaluronic acid chains through cross-linking, producing a gel formulation designed for single-injection delivery rather than a multi-injection course. Because the HA is non-animal-derived and biosynthesized via bacterial fermentation, DUROLANE® does not carry the avian-source considerations relevant to some competing viscosupplements. DUROLANE® is not a corticosteroid and does not work through the same anti-inflammatory pathway as steroid injections — it is a hyaluronic acid medical device that assists in the lubrication and cushioning of the affected joint, a distinction that is clinically relevant when comparing DUROLANE® with steroid-based intra-articular treatments. [1][4]

DUROLANE® Product Spotlight

Each DUROLANE® 60 mg/3 mL prefilled syringe contains 3 mL of NASHA-stabilized sodium hyaluronate gel at 20 mg/mL, delivering a total dose of 60 mg in a single intra-articular injection. The single-injection format means the full treatment course is administered in one clinical visit, with no additional injections required. [1]

Regarding storage: current US IFU instructions state that DUROLANE® should be stored in its original packaging between 0°C and 30°C, protected from freezing, with transient temperature spikes up to 40°C tolerated for no more than 24 hours. Refrigeration is not required under these conditions, though practitioners should confirm storage requirements from the current IFU supplied with the product, as specifications may be updated. [1]

For clinics evaluating procurement, the DUROLANE® injection cost reflects a single-syringe format rather than a multi-dose course. Wholesale pricing, product availability, and documentation requirements can vary by market and account status. Practitioners looking to purchase DUROLANE® through Doctor Medica can review the catalogue and contact representatives for current availability and lot documentation. [1]

Treatment Areas and Patient Indications

In the United States, DUROLANE® is indicated for the treatment of pain in osteoarthritis of the knee in patients who have not responded adequately to conservative non-pharmacological therapy or simple analgesics such as acetaminophen. This positions DUROLANE® knee injection as a single-visit, non-surgical management option for patients with persistent knee OA pain who have already tried physical therapy, activity modification, or oral analgesics without adequate relief. [1]

International and Canadian DUROLANE® materials describe a broader indication profile that includes mild-to-moderate osteoarthritis pain in the knee, hip, ankle, fingers, and toes in applicable markets. Ankle osteoarthritis is clinically relevant in this broader context, and DUROLANE® is one of the few single-injection viscosupplements with documented use across multiple joints in markets where locally authorized. Practitioners managing ankle osteoarthritis should confirm whether the local IFU supports its use in their jurisdiction before administering it. [1][2]

Contraindications per US labeling include known hypersensitivity or allergy to hyaluronic acid preparations, active joint infection, and skin disease or infection at the injection site. As with all intra-articular products, patient screening, review of current prescribing information, and clinical judgment are essential before administration. [1]

Administration — DUROLANE® Injection Protocol and Recovery

DUROLANE® is administered by a qualified medical professional as a single intra-articular injection into the affected knee joint using strict aseptic technique. Before injecting, any joint effusion should be aspirated to reduce intra-articular pressure and optimize delivery. The US IFU recommends an 18–22G needle of adequate length; the full 3 mL contents of the syringe are injected into the synovial capsule. When both knees require treatment, a separate syringe must be used for each. Practitioners may guide needle placement using anatomical landmarks or ultrasound imaging guidance depending on training, joint anatomy, and clinic protocol. [1]

How Long Before DUROLANE® Injections Work

Some individuals may notice symptomatic relief within days to weeks of the injection, with full benefit typically developing over the following weeks. A randomized controlled trial demonstrated that a single DUROLANE® injection provided pain-reduction benefit in knee OA for up to 26 weeks, showing non-inferiority to a multi-injection hyaluronic acid comparator over that period. [1][3]

Walking After a DUROLANE® Injection

Most patients are able to walk immediately following the procedure. The US IFU advises avoiding strenuous activity and prolonged weight-bearing for 48 hours after injection. Recovery after DUROLANE® injection is generally brief — most patients resume routine activities within one to two days while observing post-injection activity restrictions. [1]

Why Practitioners Choose DUROLANE®

Two clinical features differentiate DUROLANE® for practitioners evaluating single-injection viscosupplementation options. The first is its evidence-backed single-injection format: a randomized controlled trial demonstrated that a single 60 mg DUROLANE® injection was non-inferior to a multi-injection HA course over 26 weeks, supporting the clinical case for single-visit viscosupplementation without compromising the duration of effect. Real-world observational data from a six-year cohort study further suggest durable patient-reported benefit with repeated DUROLANE® injections over time, though practitioners should note the observational nature of that evidence. [3][5]

The second differentiator is its variety of indications in international markets. While the US label covers knee osteoarthritis, Canadian and other international DUROLANE® materials include additional joints — knee, hip, ankle, fingers, and toes — in applicable markets. For practitioners working across jurisdictions or evaluating viscosupplementation options for patients with ankle OA, DUROLANE®’s documented multi-joint use in its international labeling sets it apart from most single-injection competitors, which are confined to knee use. [2]

DUROLANE® vs Competing Viscosupplements

DUROLANE® vs MONOVISC®

DUROLANE® and MONOVISC® are both single-injection hyaluronic acid viscosupplements, making the comparison particularly relevant for clinics that have already committed to a single-visit protocol. DUROLANE® uses NASHA cross-linked technology, while MONOVISC® is a lightly cross-linked ultra-pure HA product. The products differ in source, cross-linking method, and indication labeling — DUROLANE®’s international multi-joint labeling is a point of differentiation for practices with diverse OA treatment needs. Clinics that stock multiple single-injection HA options can buy MONOVISC® through Doctor Medica. [1][2]

DUROLANE® vs SYNVISC®

DUROLANE® is a non-animal-derived NASHA hyaluronic acid product, while SYNVISC® products are based on avian-derived hylan G-F 20. SYNVISC-One® offers a single-injection format that parallels the convenience of DUROLANE®, whereas the original SYNVISC® course requires three weekly injections. The key distinction in patient selection is source — practitioners treating patients with avian protein sensitivities may find DUROLANE®’s non-animal-derived formulation to be the more appropriate option. Practices evaluating both cross-linked single-injection options can buy SYNVISC® through Doctor Medica. [1][4]

DUROLANE® vs ORTHOVISC®

DUROLANE® is administered as a single injection, while ORTHOVISC® is typically delivered as a 3- to 4-injection weekly course. Both are non-avian hyaluronic acid products, making the comparison relevant to practices that have ruled out avian-derived options. The primary consideration between them is scheduling — single-visit versus staged administration — as well as the respective evidence bases for each product. Practices building a non-avian HA formulary that includes multi-injection options can buy ORTHOVISC® through Doctor Medica. [1]

DUROLANE® vs EUFLEXXA®

DUROLANE® is a single-injection product, while EUFLEXXA® is administered as a 3-injection weekly course. Both are non-avian sodium hyaluronate products produced via biofermentation. Clinics comparing the two typically weigh single-visit administration against a staged, multi-week approach for the same patient population. Practices that offer both formats within their non-avian HA inventory can buy EUFLEXXA® through Doctor Medica. [1]

DUROLANE® vs HYALGAN®

DUROLANE® uses non-animal-stabilized, cross-linked hyaluronic acid and is administered as a single injection, while HYALGAN® is an avian-derived, non-cross-linked sodium hyaluronate typically given as a multi-injection course. The comparison is relevant for practices evaluating source and injection frequency together. Clinics that maintain both avian-derived and non-animal-derived HA options for patient-specific selection can buy HYALGAN® through Doctor Medica. [1]

DUROLANE® vs SUPARTZ®

DUROLANE® is a single-injection non-animal-derived NASHA HA gel, while SUPARTZ® is an avian-derived sodium hyaluronate administered as a multi-injection weekly series. The structural distinctions — cross-linking, source, and injection schedule — are the primary clinical differentiators. Practitioners who want to evaluate both product types from a single verified source can buy SUPARTZ® through Doctor Medica. [1]

DUROLANE® Safety Profile — Side Effects and Contraindications

The safety profile of DUROLANE® is broadly consistent with intra-articular hyaluronic acid products as a class. Adverse effects listed in US labeling include injection-site reaction, joint swelling, knee pain, stiffness, effusion, erythema, paraesthesia, and other local or joint-related events. Transient pain or swelling following intra-articular injection is common with HA and typically resolves without intervention; systematic evidence on intra-articular HA supports a tolerability profile that is generally favorable relative to corticosteroid injections over longer follow-up periods. Patients should be monitored for persistent or worsening symptoms, fever, or signs of infection. [1][4]

Risks associated with DUROLANE® injections include improper needle placement, infection, extra-articular injection, and hypersensitivity reactions. DUROLANE® is contraindicated in patients with known hypersensitivity to hyaluronic acid preparations, active joint infection, and skin disease or infection at the injection site. Practitioners should apply strict aseptic technique throughout preparation and administration and consult the current IFU for complete precautions, contraindications, and adverse event reporting requirements. [1]

Regulatory Status, Billing, and Coverage

DUROLANE® received US FDA premarket approval in September 2017 under PMA P170007 for the treatment of pain from knee osteoarthritis in patients who have not responded adequately to conservative non-pharmacological therapy or simple analgesics. The product is classified as a medical device under FDA regulation. [1]

For billing purposes, the DUROLANE® J code is HCPCS J7318, described as hyaluronan or derivative, DUROLANE®, for intra-articular injection, 1 mg. The DUROLANE® CPT code for the injection procedure is typically CPT 20610 for major joint injection, or CPT 20611 when ultrasound guidance with permanent recording and reporting is used. Applicable code selection depends on payer rules and documentation standards, which should be verified from current CMS resources and payer-specific requirements before claim submission.

Medicare coverage for DUROLANE® injections may be available when applicable viscosupplementation criteria are met, including FDA-approved labeling, documented medical necessity, appropriate diagnosis, utilization limits, and repeat-course timing requirements. Clinic teams should verify the current CMS LCD or article requirements and the patient’s payer-specific eligibility before billing. DUROLANE®’s NDC number for the 60 mg/3 mL syringe is listed as 89130-2020-01 in public distributor records — practitioners should confirm the current NDC on official product packaging or distributor documentation before billing, as product codes are subject to change.

About the Manufacturer

The current US Instructions for Use identify Q-Med AB of Uppsala, Sweden, as the manufacturer of DUROLANE®, and Bioventus LLC of Durham, North Carolina, as the US distributor. Bioventus is a medical technology company focused on orthobiologics and active healing solutions for musculoskeletal conditions; DUROLANE® is part of its osteoarthritis pain management portfolio. The NASHA cross-linking technology that underpins DUROLANE® was developed by Q-Med, which also developed the platform used across other NASHA-based HA products. [1]

Doctor Medica supplies licensed practitioners with DUROLANE® and a broader range of orthopedic injectable products through verified channels. Clinics whose practices also include aesthetic indications can buy HA dermal fillers or buy dermal fillers through Doctor Medica’s aesthetic injectable selection.

Doctor Medica has supplied verified orthopedic injectable products to licensed medical professionals since 2006, with competitive wholesale pricing, guaranteed authenticity, and verifiable LOT numbers. Licensed practitioners looking to buy DUROLANE® online, buy DUROLANE® wholesale, order DUROLANE® online, or purchase DUROLANE® can browse the Doctor Medica catalogue or contact representatives for availability, lot documentation, and procurement support. Clinics can also browse and buy orthopedic injections available through Doctor Medica.

FAQs

What is DUROLANE®?

DUROLANE® is a single-injection NASHA hyaluronic acid viscosupplement supplied as a 60 mg/3 mL prefilled syringe. In the US, it is indicated for symptomatic relief of knee osteoarthritis pain; international labeling extends its use to additional joints, including the ankle, in applicable markets. [1][2]

Is DUROLANE® a steroid?

No. DUROLANE® is a hyaluronic acid medical device, not a corticosteroid. It works by supplementing synovial fluid to support joint lubrication and cushioning — a fundamentally different mechanism from steroid injections. [1][4]

How does DUROLANE® work?

DUROLANE® is a gel preparation containing NASHA-stabilized sodium hyaluronate that replenishes joint fluid and helps restore the lubrication and cushioning properties of the osteoarthritic joint. The NASHA cross-linking is designed to support extended residence time in the joint following a single injection. [1]

Is DUROLANE® approved for ankle osteoarthritis?

In the US, DUROLANE® is indicated for knee osteoarthritis. Canadian and international labeling describes approved use for mild to moderate OA pain in the knee, hip, ankle, fingers, and toes where locally authorized. Practitioners should verify the local IFU before using DUROLANE® for joints other than the knee. [1][2]

How long does it take for DUROLANE® injection to work?

Relief may begin within days to weeks of injection, with full benefit typically developing over the following weeks. A randomized controlled trial demonstrated pain-reduction benefit in knee OA for up to 26 weeks from a single injection. Individual outcomes vary by patient, OA severity, and joint status. [3]

Can you walk after a DUROLANE® injection?

Most patients can walk immediately after injection. The US IFU advises avoiding strenuous activity and prolonged weight-bearing for 48 hours after the procedure, with most patients returning to routine activities within one to two days. [1]

Does DUROLANE® need to be refrigerated?

No. The US IFU specifies storage at 0°C to 30°C in the original packaging, protected from freezing. Refrigeration is not required, though practitioners should confirm storage requirements from the current IFU supplied with each product. [1]

Does Medicare cover DUROLANE® injections?

Medicare coverage may be available when applicable viscosupplementation criteria are met, including documented medical necessity, appropriate diagnosis, and utilization requirements. Clinic teams should verify current CMS policy and patient-specific eligibility before billing.

Where can practitioners buy DUROLANE® wholesale?

Licensed practitioners can buy DUROLANE® injection online or wholesale through Doctor Medica’s professional catalogue. Doctor Medica supplies verified orthopedic injectables with competitive wholesale pricing, verifiable LOT numbers, and representative support for product availability and documentation.

Citations

1. US Food and Drug Administration. DUROLANE® Instructions for Use / PMA P170007 Summary of Safety and Effectiveness Data. 2017. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170007D.pdf
2. DUROLANE Canada. Prescribing Information for DUROLANE®.https://www.durolane.ca/wp-content/uploads/2024/08/durolane-ifu-CA24.pdf
3. Zhang H, Zhang K, Zhang X, et al. Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz. Arthritis Research & Therapy. 2015. https://pubmed.ncbi.nlm.nih.gov/25889322/
4. Leighton R, Fitzpatrick J, Smith H, Crandall D, Flannery CR, Conrozier T. Systematic clinical evidence review of NASHA (Durolane hyaluronic acid) for the treatment of knee osteoarthritis. Open Access Rheumatology: Research and Reviews. 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5967379/
5. Carney G, Harrison A, Fitzpatrick J. Long-Term Outcome Measures of Repeated Non-Animal Stabilized Hyaluronic Acid (Durolane) Injections in Osteoarthritis: A 6-Year Cohort Study with 623 Consecutive Patients. Open Access Rheumatology: Research and Reviews. 2021. https://pubmed.ncbi.nlm.nih.gov/34566438/

For licensed medical professionals only. This content is for informational purposes only and does not constitute medical advice.