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About DUROLANE® and Its Manufacturer
DUROLANE® is a single-injection hyaluronic acid medical device indicated for the intra-articular treatment of symptomatic osteoarthritis, with knee indications in the US and expansion to ankle or hip joints internationally [5]. It is manufactured by Q-Med AB (Uppsala, Sweden) and distributed globally by Bioventus LLC, a company specializing in clinically validated orthobiologic solutions for joint preservation and pain management. Q-Med’s expertise in NASHA technology — originally developed for aesthetic applications — has been adapted and refined specifically for orthopedic viscosupplementation.
DUROLANE® offers treatment flexibility across distinct geographic labels, managing knee osteoarthritis in the US and expanding to ankle or hip presentations internationally. It has received FDA Premarket Approval (PMA) as a medical device for the treatment of pain associated with knee osteoarthritis in the United States [4]. In Europe and other international markets, it holds regulatory approvals for both knee and ankle osteoarthritis, allowing international practitioners expanded clinical utility [4][5].
DUROLANE® Technology — NASHA and Joint Lubrication
NASHA (Non-Animal Stabilized Hyaluronic Acid) technology involves controlled cross-linking of biofermentation-derived hyaluronic acid, producing a stabilized gel with extended intra-articular residence time compared to non-cross-linked HA products [1][3]. Because DUROLANE® is manufactured from non-animal sources, it eliminates concerns associated with avian-derived proteins, supporting a favorable tolerability profile [1][3].
DUROLANE® works by replenishing the lubricating and shock-absorbing properties of synovial fluid within the affected joint. The gel preparation replenishes joint fluid and may stimulate the production of new hyaluronic acid, thereby restoring viscoelastic properties diminished in osteoarthritic joints [1][3]. This dual-action mechanism — supplementing existing synovial fluid while supporting endogenous HA synthesis — contributes to the extended symptom relief observed across clinical studies [1][3].
Practitioners are sometimes asked by patients whether DUROLANE® is a steroid. It is not. DUROLANE® is a hyaluronic acid medical device and contains no corticosteroid ingredients; its mechanism is viscosupplementation, not immunosuppression [4][5].
DUROLANE® Product Spotlight — 60 mg/3 mL Single-Injection Format
DUROLANE® 60 mg/3 mL is the single-SKU formulation available through Medica Depot [5]. Each prefilled syringe delivers a standardized 60 mg dose of NASHA hyaluronic acid in 3 mL, designed for a single intra-articular injection [5]. The product is supplied as a sterile, clear, viscoelastic gel in a glass syringe for single use only [5].
Storage and Handling
Per the current prescribing information, DUROLANE® should be stored between 0°C and 30°C (32°F–86°F) and must not be frozen [5]. Refrigeration is not required under recommended storage conditions, which supports straightforward clinic inventory management. Practitioners should always follow the most current manufacturer storage guidance from the product IFU [5].
Practitioners wishing to order DUROLANE® online can source the product through Medica Depot with verified LOT numbers and original manufacturer packaging.
Treatment Areas and Patient Indications
DUROLANE® has received FDA Premarket Approval (PMA) for symptomatic pain associated with knee osteoarthritis in the United States and is indicated for ankle osteoarthritis in applicable international markets per local regulatory labeling [4]. This regional joint coverage positions DUROLANE® as a flexible option for international and domestic practitioners managing OA caseloads.
DUROLANE® injections for knees — and for ankle OA where indicated — are suited to patients with mild to moderate osteoarthritis who have not responded adequately to conservative non-pharmacological therapy or simple analgesics. The single-injection format makes it a practical choice for patients seeking fewer clinic visits than multi-injection HA protocols [2], or for those for whom oral NSAID use is limited by gastrointestinal or renal considerations.
Contraindications
These include known hypersensitivity to hyaluronic acid or any DUROLANE® component, active infection or sepsis in the target joint, and skin disease or breakdown at the proposed injection site [5]. Practitioners should review the full contraindication and precaution information in the product IFU before administering.
Administration and Recovery
DUROLANE® is administered as a single intra-articular injection by a licensed and trained healthcare professional using proper aseptic technique [5]. If joint effusion is present, the synovial fluid should be aspirated before injection to optimize delivery and reduce intra-articular pressure. The needle should be guided by anatomical landmarks or imaging guidance — such as ultrasound or fluoroscopy — to ensure accurate entry into the joint space [5].
DUROLANE® Injection Dosage
It is a single 3 mL intra-articular administration containing 60 mg of NASHA-stabilized hyaluronic acid [5]. The full dose should be injected into the joint cavity; the syringe is for single use only [5].
Initial symptom improvement may begin within days to several weeks following treatment, though response times vary among patients [1]. Most patients can walk immediately after the procedure. Strenuous weight-bearing activity (e.g., running, jumping, and prolonged standing) is generally recommended to be avoided for 24–48 hours post-injection [5]. Recovery after DUROLANE® injection is typically brief, with most patients returning to normal activities within one to two days [5].
Why Practitioners Choose DUROLANE®
Two characteristics distinguish DUROLANE® in the single-injection viscosupplement category.
First, its extensive regulatory footprint provides clinical flexibility across multiple joints depending on the region. While it is indicated solely for the knee in the US, its international label addresses both knee and ankle presentations, providing international practitioners with a broader single-SKU solution for diverse patient groups [1].
Second, the NASHA stabilization technology extends the residence time of hyaluronic acid in the joint to approximately 1 month [1]. DUROLANE® supports sustained symptom relief following a single visit. This reduces the treatment burden associated with multi-injection protocols and supports patient compliance by requiring only one injection per treatment cycle [2][3].
Regulatory Status and Billing
DUROLANE® has received FDA Premarket Approval (PMA) as a medical device for the treatment of pain associated with knee osteoarthritis, and is approved in Europe and other international markets for knee and ankle osteoarthritis [4]. Practitioners should confirm the applicable regulatory status and approved indications for their specific market before ordering or administering.
For billing, DUROLANE® is typically billed using the applicable J code for sodium hyaluronate viscosupplement injection and the corresponding intra-articular injection CPT code. Because reimbursement codes are subject to periodic updates by CMS, practitioners should verify the current DUROLANE® J code and CPT code directly through CMS resources or their billing department before submitting claims.
DUROLANE® NDC numbers may vary by packaging configuration and distribution channel. Providers should verify the current NDC number in manufacturer documentation, on product packaging, or in official payer resources before billing.
Medicare Part B covers FDA-authorized HA viscosupplements for knee OA in many cases under applicable coverage policies, though coverage criteria, prior authorization requirements, and patient cost-sharing responsibilities vary by region and individual plan. Practitioners should verify coverage with the patient’s specific plan and obtain prior authorization where required. Private insurance coverage is similarly variable.
DUROLANE® vs. Competing Viscosupplements
DUROLANE® vs. MONOVISC®
Both DUROLANE® and MONOVISC® are single-injection hyaluronic acid viscosupplements that reduce the overall treatment burden compared to multi-injection protocols. DUROLANE® uses NASHA-stabilized HA and carries indications for both knee and ankle OA, while MONOVISC® utilizes a high-molecular-weight, lightly cross-linked HA formulation [1]. Furthermore, MONOVISC® is FDA-approved exclusively for the knee in the US, though, like DUROLANE®, it holds multi-joint clearances in markets such as Canada and Europe. Practitioners evaluating both single-injection options can buy MONOVISC® or buy orthopedic injections at Medica Depot to compare formulation approaches directly.
DUROLANE® vs. SYNVISC® (SYNVISC-ONE®)
DUROLANE® and SYNVISC-ONE® are both single-injection viscosupplements for the management of osteoarthritis. DUROLANE® uses non-animal-derived NASHA technology, whereas SYNVISC-ONE® contains avian-derived hylan G-F 20 — a distinction relevant for practitioners and patients with concerns about avian-sourced materials [1][3]. Practitioners weighing these two approaches can buy SYNVISC® through Medica Depot.
DUROLANE® vs. ORTHOVISC®
ORTHOVISC® is administered as a course of 3–4 injections over several weeks, in contrast to DUROLANE®’s single-injection format. Both provide symptomatic relief of knee OA; the difference lies primarily in the injection schedule and patient visit frequency [2]. Practitioners whose patients prefer or require a multi-injection protocol can buy ORTHOVISC® at Medica Depot.
DUROLANE® vs. EUFLEXXA®
EUFLEXXA® is a non-avian HA viscosupplement administered as a 3-injection course over 3–4 weeks. Like DUROLANE®, it is non-animal-derived, offering a comparable tolerability profile; the primary difference is the single-injection versus multi-injection treatment schedule [2]. Practitioners considering non-avian, multi-injection alternatives can buy EUFLEXXA® at Medica Depot.
DUROLANE® vs. HYALGAN®
HYALGAN® is an avian-derived, non-cross-linked sodium hyaluronate administered as a 3–5 injection series. DUROLANE® is non-animal-derived and requires only a single injection, representing a different approach in both source material and treatment schedule [2]. Practitioners evaluating both options can buy HYALGAN® through Medica Depot.
DUROLANE® vs. SUPARTZ®
SUPARTZ® is an avian-derived, non-cross-linked sodium hyaluronate administered across a 3–5 injection protocol. The key differences from DUROLANE® are source material (avian vs. non-animal), HA stabilization method (non-cross-linked vs. NASHA), and injection schedule (multi-session vs. single injection) [2][3]. Practitioners seeking avian-derived multi-injection alternatives can buy SUPARTZ® from Medica Depot.
DUROLANE® Safety Profile — Side Effects and Contraindications
Adverse events reported across clinical studies of DUROLANE® are primarily localized and transient [1][3]. The most commonly observed reactions at the injection site include temporary pain or discomfort, mild swelling or an increase in effusion, transient warmth or redness, and brief joint stiffness, all of which typically resolve within a few days without intervention [1][3]. In rare cases, more significant adverse events such as persistent joint pain, pronounced swelling accompanied by warmth and fever, or signs of joint infection have been reported; practitioners should be alert to these presentations and advise patients to seek prompt medical attention if they occur [3].
Contraindications include known hypersensitivity to hyaluronic acid or any DUROLANE® component, active infection or sepsis in the target joint, and skin disease or breakdown at the proposed injection site [5]. Caution is warranted in patients with venous or lymphatic insufficiency, bleeding disorders, or those on anticoagulant therapy [5]. Safety in pregnancy, lactation, and pediatric populations has not been established [5]. Practitioners should review the full safety and contraindication information in the current DUROLANE® IFU before prescribing or administering.
Order DUROLANE® at wholesale pricing through Medica Depot, where licensed practitioners access competitive group buy options, verified LOT numbers for full traceability, and fast shipping. Buy DUROLANE® injection online or add to cart directly — and for practices managing broader aesthetic and regenerative protocols, Medica Depot also supports those looking to buy dermal fillers or buy HA dermal fillers alongside orthopedic products. Purchase DUROLANE® or contact our team today for bulk pricing and group purchase arrangements.
Frequently Asked Questions
What is DUROLANE®?
DUROLANE® is a single-injection NASHA hyaluronic acid viscosupplement — 60 mg/3 mL — indicated for the symptomatic relief of osteoarthritis of the knee and ankle [1][4].
Is DUROLANE® approved for ankle osteoarthritis?
DUROLANE® is FDA-approved exclusively for knee osteoarthritis within the United States [4]. However, it is approved for both knee and ankle osteoarthritis in Canada, Europe, and other international markets [5]. Practitioners should verify local regulatory labeling for their specific region before administering.
How does DUROLANE® work?
DUROLANE® replenishes joint fluid and may stimulate the production of new hyaluronic acid, restoring synovial fluid viscoelasticity and supporting joint lubrication through its NASHA-stabilized formulation [1][3].
Is DUROLANE® a steroid?
No. DUROLANE® is a hyaluronic acid medical device, not a corticosteroid. It contains no steroid ingredients and works through viscosupplementation rather than immunosuppression [4][5].
Can you walk after a DUROLANE® injection?
Yes — most patients can walk immediately after the procedure, though strenuous weight-bearing activity is generally recommended to be avoided for 24–48 hours post-injection [5].
How long does it take for DUROLANE® injection to work?
Initial symptom improvement may begin within days to several weeks following injection, with progressive improvement typically developing over subsequent weeks [1].
Does DUROLANE® need to be refrigerated?
DUROLANE® does not require refrigeration. Per the current prescribing information, it should be stored at 0–30°C (32–86°F) and must not be frozen [5]. Practitioners should always follow the most current manufacturer storage instructions.
What is the DUROLANE® J code and CPT code?
DUROLANE® is typically billed using the applicable J code for hyaluronate viscosupplement injection and the corresponding intra-articular injection CPT code. Because codes are subject to CMS updates, practitioners should verify current codes with CMS resources or their billing department before submitting claims.
DUROLANE® vs MONOVISC® — what’s the difference?
Both are single-injection HA viscosupplements derived from non-animal biofermentation. DUROLANE® utilizes a specific NASHA cross-linking gel technology, whereas MONOVISC® features a highly concentrated, lightly cross-linked sodium hyaluronate. Additionally, their multi-joint indication approvals vary depending on whether you are practicing in the US or international markets [1].
Where can I order DUROLANE® at wholesale pricing?
Medica Depot offers wholesale access to DUROLANE® for licensed practitioners, with competitive group-buy pricing, verified LOT numbers, and fast shipping. Add to cart or contact our team for bulk arrangements.
Disclaimer
The contents of this page are meant for licensed medical professionals. They serve informational purposes only and are not to be taken as medical advice.
Citations
- Altman RD, Akermark C, Beaulieu AD, Schnitzer T. Durolane International Study Group. Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2004. https://pubmed.ncbi.nlm.nih.gov/15262244/
- 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 Rheumatol. 2018. https://pmc.ncbi.nlm.nih.gov/articles/PMC5967379/
- United States Food and Drug Administration, DUROLANE Premarket Approval (PMA) P170007, FDA, 2017, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170007
- United States Food and Drug Administration, DUROLANE Instructions for Use / Summary of Safety and Effectiveness Data, FDA, 2017, https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170007D.pdf
- Bioventus LLC, DUROLANE Prescribing Information, Bioventus / DUROLANE Canada, 2024, https://www.durolane.ca/en/durolane/prescribing-information/