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Suppliers and packagers for generic pharmaceutical drug: TECHNETIUM TC-99M PENTETATE KIT
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TECHNETIUM TC-99M PENTETATE KIT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
---|---|---|---|---|---|---|---|---|---|
Curium | TECHNETIUM TC-99M PENTETATE KIT | technetium tc-99m pentetate kit | INJECTABLE;INJECTION | 215146 | ANDA | Curium US LLC | 69945-314-05 | 5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01) | 2025-04-08 |
Curium | TECHNETIUM TC-99M PENTETATE KIT | technetium tc-99m pentetate kit | INJECTABLE;INJECTION | 215146 | ANDA | Curium US LLC | 69945-314-30 | 30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01) | 2025-04-08 |
Jubilant | DRAXIMAGE DTPA | technetium tc-99m pentetate kit | INJECTABLE;INJECTION | 018511 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-288-30 | 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30) | 1989-12-29 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Technetium Tc 99m Pentetate Kit: A Comprehensive Analysis
Technetium Tc 99m Pentetate Kit, commonly referred to as DTPA (diethylenetriaminepentaacetic acid), is a radioactive diagnostic agent integral to nuclear medicine. Primarily used for lung ventilation imaging in ventilation/perfusion (V/Q) scans, renal visualization, and brain imaging, this kit has become a cornerstone in diagnosing conditions such as pulmonary embolism and assessing glomerular filtration rates. Recent developments, including the FDA approval of Curium’s generic DTPA in April 2025, have reshaped the market landscape, offering healthcare providers enhanced supply chain reliability and expanded product options[1][3]. This report delves into the chemical composition, manufacturing, clinical applications, regulatory dynamics, and future prospects of this critical radiopharmaceutical.
Chemical Composition and Formulation
Core Components and Structural Properties
Technetium Tc 99m Pentetate Injection is synthesized from a lyophilized kit containing sterile, non-pyrogenic ingredients. Each 10 mL reaction vial includes 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and a stannous chloride dihydrate component ranging from 0.25 mg to 0.385 mg[4][6]. The formulation is sealed under nitrogen to prevent oxidation, ensuring stability during storage. Upon reconstitution with sodium pertechnetate Tc 99m, the kit forms a complex with the chemical structure ( \text{Technetate (1-)^{99m}Tc, [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium} ), which exhibits high radiochemical purity (≥90%) for optimal imaging[4][8].
Reconstitution and Stability
The labeling efficiency of Technetium Tc 99m Pentetate depends on maintaining stannous ions in a reduced state. Sodium pertechnetate solutions older than two hours or containing oxidants are unsuitable, as they compromise labeling efficacy[6]. Post-reconstitution, the solution remains stable for 12 hours at 15–30°C (59–86°F), stored in lead shielding to minimize radiation exposure[1][4].
Manufacturing and Supplier Landscape
Key Manufacturers and Regulatory Compliance
The global production of Technetium Tc 99m Pentetate Kits involves prominent pharmaceutical entities such as Curium, Jubilant Radiopharma, Biophore India Pharmaceuticals, and Bayer AG[2][7]. Manufacturing facilities adhere to Good Manufacturing Practices (GMP), with regulatory filings including USDMF (U.S. Drug Master Files) and JDMF (Japanese Drug Master Files) to meet regional standards[2][7]. Curium’s recent FDA approval for its generic DTPA in 2025 underscores its commitment to GMP compliance, offering identical indications and packaging options (5-vial clamshells or 30-vial cartons) as the reference product, DRAXIMAGE® DTPA[1][3].
Pricing and Supply Chain Dynamics
The API price for pentetic acid fluctuates based on market demand, regulatory changes, and negotiated contracts. For instance, Curium’s entry as a second supplier has introduced competitive pricing, with reimbursement facilitated under HCPCS Code A9539[1][3]. PharmaCompass highlights the role of distributors and traders in bridging gaps between manufacturers and end-users, particularly in regions with stringent import regulations[2][7].
Clinical Applications and Diagnostic Utility
Pulmonary Embolism and V/Q Scans
Technetium Tc 99m Pentetate is indispensable in V/Q scans for diagnosing pulmonary embolism. When nebulized and inhaled, the radio-aerosol distributes uniformly in ventilated lung regions, while concomitant perfusion imaging with Pulmotech™ MAA (technetium Tc 99m albumin aggregated) identifies blood flow mismatches[1][4]. This dual approach achieves a sensitivity of 85–90% and specificity of 95% for acute emboli, per clinical studies[6][8].
Renal and Neurological Imaging
Beyond pulmonary applications, the agent is used for renal perfusion visualization and glomerular filtration rate (GFR) estimation in pediatric and adult patients. In brain imaging, it aids in detecting cerebrospinal fluid leaks and ventriculoperitoneal shunt patency, leveraging its rapid renal excretion (half-life: 6 hours) to minimize radiation exposure[4][8].
Safety Profile and Contraindications
Radiation Safety and Handling
As with all radiopharmaceuticals, Technetium Tc 99m Pentetate mandates stringent radiation safety protocols. Clinical personnel must use lead shields (≥3 mm thickness) and waterproof gloves during preparation, while patients are advised to hydrate post-administration to accelerate renal excretion[4][6]. Curium’s prescribing information emphasizes dose optimization to align with the ALARA (As Low As Reasonably Achievable) principle[1].
Hypersensitivity and Pulmonary Risks
Pulmotech™ MAA, often used alongside DTPA in V/Q scans, is contraindicated in patients with severe pulmonary hypertension or albumin hypersensitivity, due to risks of anaphylaxis[1][4]. Similarly, Xenon Xe 133 Gas—another component of Curium’s V/Q suite—requires careful handling to avoid leakage and ensure adequate ventilation[1].
Regulatory Approvals and Market Dynamics
FDA Approvals and Generic Competition
The FDA’s approval of Curium’s generic DTPA in 2025 marked a pivotal shift, ending Jubilant Radiopharma’s monopoly under the DRAXIMAGE® brand[3]. Curium’s product, bioequivalent and sharing the same NDC codes (69945-314-05 and 69945-314-30), has expanded access to cost-effective diagnostic solutions[1][3]. This approval aligns with the FDA’s push to mitigate drug shortages, as seen in the 2020 temporary importation of Technetium Tc99m Succimer during supply crises[9].
Global Regulatory Filings
Manufacturers navigate diverse regulatory frameworks, including the European Pharmacopoeia and WHO GMP guidelines, to market DTPA internationally. Certificates of Analysis (CoA) and Drug Master Files (DMF) ensure batch-level quality control, with PharmaCompass serving as a critical platform for supplier verification[2][7].
Patent Status and Future Directions
Patent Expirations and Generic Entry
Jubilant Radiopharma’s patent for DRAXIMAGE® DTPA expired in 2023, enabling Curium and other generics to enter the market[3][11]. DrugPatentWatch data reveal that technetium-based agents like Mertiatide and Medronate face similar generic competition, driven by patent cliffs and FDA incentives[5][11].
Innovations in Radiopharmaceuticals
Emerging trends include theranostic pairings (e.g., combining DTPA with lutetium-177 therapies) and dry-kit formulations to extend shelf life beyond 24 months[1][3]. Curium’s investment in a “one-stop-shop” model for V/Q scans exemplifies industry efforts to consolidate supply chains and enhance clinical convenience[3].
Key Takeaways
- Technetium Tc 99m Pentetate Kit is vital for lung, renal, and brain imaging, with recent generic approvals improving supply chain resilience.
- Curium’s 2025 FDA approval introduced bioequivalent DTPA, challenging Jubilant Radiopharma’s market dominance.
- Safety protocols, including radiation shielding and contraindication management, are critical to minimizing adverse events.
- Global manufacturing relies on GMP compliance and regulatory filings such as USDMF and JDMF to ensure quality.
- Future innovations may focus on theranostic applications and enhanced formulation stability.
Frequently Asked Questions
How does Technetium Tc 99m Pentetate compare to other renal imaging agents?
Unlike DMSA (dimercaptosuccinic acid), which binds to renal tubules, DTPA is filtered by glomeruli, making it preferable for GFR estimation[8][9].
What are the storage requirements for unreconstituted DTPA kits?
Unreconstituted vials must be stored at 15–30°C (59–86°F), protected from light and moisture, to maintain stability until reconstitution[1][4].
Can DTPA be used in pediatric patients?
Yes, DTPA is approved for renal imaging in pediatric populations, with dosage adjustments based on body weight[4][6].
What distinguishes Curium’s DTPA from DRAXIMAGE®?
Curium’s product shares identical indications, packaging, and HCPCS codes but offers competitive pricing and broader distribution networks[1][3].
How does radiation exposure from DTPA compare to CT scans?
Effective radiation doses from DTPA (~0.7 mSv) are significantly lower than CT pulmonary angiography (~4 mSv), making it a safer option for repeated studies[6][8].
"Our generic version of DTPA allows Curium to offer a more comprehensive list of products used in V/Q scans, which helps customers simplify and manage their supply chain." — Mike Patterson, CEO of Curium North America[3].
References
- https://www.curiumpharma.com/product/dtpa/
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/technetium-tc-99m-pentetate-kit
- https://www.biospace.com/press-releases/curium-announces-approval-of-generic-dtpa-kit-for-the-preparation-of-technetium-tc-99m-pentetate-injection-in-the-u-s
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf
- https://jnm.snmjournals.org/content/jnumed/21/5/local/advertising.pdf
- https://pdf.hres.ca/dpd_pm/00012174.PDF
- https://www.pharmacompass.com/active-pharmaceutical-ingredients/technetium-tc-99m-pentetate-kit
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=becdab53-f7a7-7280-6930-21f3a61b99e7
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa643e8a-a8d2-4868-92ad-98dd17e92172
- https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=DTPA
- https://www.drugpatentwatch.com/p/generic-api/technetium+tc-99m+mertiatide+kit
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