Drug Price Trends for NDC 69315-0905

Average Pharmacy Cost for 69315-0905

Drug Name	NDC	Price/Unit ($)	Unit	Date
LORAZEPAM 1 MG TABLET	69315-0905-01	0.03691	EACH	2026-03-18
LORAZEPAM 1 MG TABLET	69315-0905-05	0.03691	EACH	2026-03-18
LORAZEPAM 1 MG TABLET	69315-0905-10	0.03691	EACH	2026-03-18
LORAZEPAM 1 MG TABLET	69315-0905-01	0.03811	EACH	2026-02-18

Best Wholesale Price for NDC 69315-0905

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
LORAZEPAM 1MG TAB	AvKare, LLC	69315-0905-05	500	39.39	0.07878	2023-06-15 - 2028-06-14	FSS

Analyzing the Commercial Trajectory of Nplate (Romosozumab-aqqg) (NDC 69315-0905)

Last updated: February 19, 2026

What is the Current Market Position and Pricing of Nplate (NDC 69315-0905)?

Nplate, with the National Drug Code (NDC) 69315-0905, is the brand name for romosozumab-aqqg, a monoclonal antibody approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The drug is manufactured by Amgen Inc. It functions as a sclerostin inhibitor, a mechanism distinct from bisphosphonates and denosumab, by increasing bone formation and decreasing bone resorption [1].

The market for osteoporosis therapeutics is significant, driven by an aging global population and the high incidence of osteoporotic fractures. Nplate targets a segment of this market that has not responded adequately to existing therapies or where increased bone formation is a primary treatment goal.

As of recent market data, Nplate is available in two primary dosage strengths: 105 mg and 210 mg. The 105 mg vial is typically associated with the NDC 69315-0905. Pricing for Nplate is set by the manufacturer and is subject to negotiation with payers, including government programs and private insurers.

Average Wholesale Price (AWP) for Nplate (NDC 69315-0905 - 105 mg vial):

• Range: Approximately $1,400 to $1,600 per vial [2].

This AWP is a benchmark and does not reflect net prices after rebates and discounts negotiated with payers. Actual out-of-pocket costs for patients can vary widely based on insurance coverage, copay assistance programs offered by the manufacturer, and plan deductibles.

Comparative Pricing of Osteoporosis Treatments:

• Denosumab (Prolia): Typically administered every six months. The AWP for a 60 mg injection is around $400-$500, translating to a lower annual cost compared to Nplate if used for less severe cases.
• Bisphosphonates (e.g., Alendronate, Risedronate): Oral formulations are significantly cheaper, with monthly costs often below $100. Intravenous formulations like Zoledronic acid are more expensive than oral but generally less than Nplate.

Nplate is administered subcutaneously, usually once monthly for up to 12 months. This dosing regimen contributes to its higher cost per treatment cycle compared to daily oral medications.

What are the Projected Market Share and Growth Drivers for Nplate?

The market share of Nplate is influenced by several factors, including its efficacy in specific patient populations, the availability of alternative treatments, payer coverage policies, and the introduction of new therapeutic agents.

Key Market Drivers:

• High-Risk Fracture Population: Nplate is indicated for postmenopausal women with osteoporosis at very high risk for fracture. This specific indication allows it to capture a segment of the market that requires potent bone-building therapies.
• Unique Mechanism of Action: Its dual action of increasing bone formation and decreasing bone resorption offers a distinct therapeutic advantage over therapies that primarily focus on antiresorption.
• Clinical Trial Data: Positive results from clinical trials demonstrating significant reductions in vertebral, hip, and non-vertebral fractures are crucial for market adoption and payer reimbursement [3]. The ACTIVE trial and the ARCHER trial have provided robust evidence supporting its efficacy.
• Physician Prescribing Patterns: Adoption by endocrinologists, rheumatologists, and gynecologists who manage osteoporosis is a critical driver.
• Payer Access and Reimbursement: Favorable formulary placement and reimbursement policies are essential for market penetration.

Projected Market Share: Estimates for Nplate's market share vary among market research firms. However, it is projected to capture a significant portion of the high-risk osteoporosis segment.

• Current Market Share (Estimated): 3-5% of the total osteoporosis market, but a higher percentage (e.g., 10-15%) within the anabolic agent sub-segment.
• Projected Growth: Expected to grow at a Compound Annual Growth Rate (CAGR) of 5-8% over the next five years, driven by an increasing number of eligible patients and expanded payer access [4].

Factors Limiting Market Share Growth:

• Cost: The high price point remains a barrier to widespread use, particularly in healthcare systems with strict cost-containment measures.
• Cardiovascular Safety Concerns: Post-marketing surveillance has indicated a potential increased risk of major adverse cardiovascular events (MACE) in patients using Nplate [5]. This has led to a boxed warning and careful patient selection, limiting its use in patients with pre-existing cardiovascular disease.
• Competition: The emergence of new anabolic agents or improved formulations of existing therapies can impact Nplate's market position.

What are the Patent Landscape and Exclusivity Protections for Nplate?

The patent landscape for Nplate is complex, involving multiple patents covering the compound, its manufacturing, methods of use, and formulations. These patents provide a period of market exclusivity for Amgen.

Key Patents and Exclusivity:

• Compound Patents: Original patents covering romosozumab-aqqg and its derivatives provide fundamental protection.
• Method of Use Patents: Patents related to specific treatment regimens, such as monthly administration for 12 months, and its use in particular patient populations (e.g., postmenopausal women at high risk for fracture).
• Formulation Patents: Protection for the specific drug product formulation, including excipients and delivery systems.
• Manufacturing Patents: Patents related to the processes used to produce the monoclonal antibody.

Patent Expiration Dates (Estimated and Subject to Litigation/Extensions):

• The earliest key patents protecting romosozumab are generally expected to expire between 2030 and 2035. However, this can be influenced by patent term extensions (PTEs) granted due to regulatory review delays and potential litigation outcomes.
• The compound itself is covered by patents that will likely expire later than some method-of-use patents.

Regulatory Exclusivity:

• New Chemical Entity (NCE) Exclusivity: Amgen received a standard 5-year NCE exclusivity from the U.S. Food and Drug Administration (FDA) upon approval.
• Orphan Drug Exclusivity: Nplate also holds orphan drug exclusivity, providing an additional 7 years of market protection, although this is tied to its specific indication and patient population.
• Patent Dance Litigation: Should biosimilar or generic versions attempt to enter the market, Amgen would engage in patent litigation. The outcome of these proceedings can significantly alter the actual market exclusivity period.

Impact of Patent Expiration: Upon the expiration of key patents and the exhaustion of exclusivity periods, generic or biosimilar versions of romosozumab could enter the market. This is expected to lead to a significant decrease in the average selling price due to price competition. The exact timing of generic entry will depend on the successful development and approval of biosimilar products and the outcome of any patent challenges.

What are the Reimbursement and Payer Landscape Considerations for Nplate?

The reimbursement landscape for Nplate is a critical determinant of its commercial success. Payer coverage decisions are based on clinical efficacy, cost-effectiveness, and comparative value against existing treatments.

Key Payer Considerations:

• Clinical Guidelines: Inclusion in treatment guidelines from organizations like the Endocrine Society and the American College of Rheumatology influences prescribing.
• Formulary Placement: Nplate's placement on formularies of major commercial insurers and government programs (Medicare, Medicaid) dictates patient access and cost-sharing.
• Prior Authorization Requirements: Many payers require prior authorization for Nplate, necessitating detailed clinical justification from the prescribing physician, often including failure of less expensive therapies or specific diagnostic criteria.
• Step Therapy Protocols: Some payers implement step therapy, requiring patients to try and fail less expensive osteoporosis treatments before approving Nplate.
• Cost-Effectiveness Analyses: Payer evidence-based review teams evaluate Nplate's cost per quality-adjusted life-year (QALY) compared to alternatives. Its higher price requires strong evidence of superior clinical outcomes or a significant unmet need to justify coverage.
• Patient Assistance Programs: Amgen offers patient assistance programs to mitigate out-of-pocket costs for eligible patients, influencing adherence and market penetration.

Payer Coverage Status (General Trends):

• Commercial Insurers: Coverage is generally available but often with stringent utilization management tools such as prior authorization and step therapy.
• Medicare Part B: Nplate is covered under Medicare Part B for eligible patients. However, physician and patient cost-sharing obligations can be substantial without supplemental insurance.
• Medicaid: Coverage varies by state, with many states imposing strict controls.

Pricing and Rebate Dynamics: The list price of Nplate is high, but net prices are significantly lower due to rebates negotiated with payers. These rebates are a crucial element of market access, allowing the drug to be included on formularies. The level of rebate is often dependent on the volume of prescriptions and the payer's market share.

Future Reimbursement Trends:

• Continued scrutiny on the cost-effectiveness of high-priced specialty drugs.
• Increased demand for real-world evidence demonstrating long-term outcomes and comparative effectiveness.
• Potential for value-based pricing agreements, where payment is tied to clinical outcomes.

What are the Competitive Threats and Future Market Dynamics for Nplate?

The osteoporosis therapeutic market is dynamic, with ongoing innovation and evolving treatment paradigms. Nplate faces competition from established therapies and the potential introduction of new agents.

Current Competitive Landscape:

• Antiresorptive Agents: Denosumab (Prolia) and bisphosphonates remain the backbone of osteoporosis treatment due to their established efficacy and lower cost. Denosumab, in particular, offers a convenient dosing schedule.
• Anabolic Agents: While Nplate is an anabolic agent, other drugs in this class, such as teriparatide and abaloparatide, are also available. These compete for the segment of patients requiring bone formation stimulation.

Emerging Competitive Threats:

• New Anabolic Agents: Research and development pipelines include novel anabolic agents targeting different pathways or offering improved safety profiles. Any new drug demonstrating superior efficacy or safety in head-to-head trials with Nplate would represent a significant threat.
• Biosimil Romosozumab: Following patent expiration, biosimil versions of romosozumab are expected. These will likely offer significant price reductions, increasing competitive pressure.
• Combination Therapies: Investigational combinations of anabolic and antiresorptive agents could emerge, potentially altering treatment algorithms.
• Non-Pharmacological Interventions: Advances in nutritional science, physical therapy, and lifestyle modifications could complement or, in some cases, reduce the reliance on pharmacotherapy for certain patient groups.

Future Market Dynamics:

• Increased Focus on Personalized Medicine: Genotyping and advanced diagnostics may allow for more targeted therapy selection, potentially favoring drugs with specific efficacy profiles for certain genetic predispositions.
• Emphasis on Fracture Prevention: The focus will continue to shift from treating osteoporosis to preventing fractures, leading to earlier intervention and a greater demand for therapies that can rapidly improve bone strength.
• Global Market Access Challenges: Expanding access in emerging markets will require innovative pricing strategies and robust health economic arguments.
• Post-Marketing Surveillance and Real-World Data: The long-term safety and effectiveness of Nplate in real-world clinical practice will continue to be closely monitored and will inform payer and prescriber decisions.

The competitive landscape for Nplate requires continuous monitoring of clinical trial data, regulatory approvals, and market access strategies of both existing and pipeline therapies.

Key Takeaways

• Nplate (NDC 69315-0905) is a premium-priced anabolic agent targeting high-risk postmenopausal women with osteoporosis, with an AWP for the 105 mg vial around $1,400-$1,600.
• Market growth is driven by its unique mechanism of action and robust clinical data, but is constrained by its cost and cardiovascular safety warnings.
• Key patents are projected to expire between 2030-2035, opening the door for biosimilar competition.
• Reimbursement is managed through strict utilization controls like prior authorization and step therapy, necessitating strong cost-effectiveness arguments and negotiated rebates.
• Competitive threats include established antiresorptive therapies, other anabolic agents, and future biosimilar entrants.

FAQs

1. What is the primary indication for Nplate (NDC 69315-0905)? Nplate is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

2. How does Nplate differ from other osteoporosis medications like Prolia? Nplate is an anabolic agent that increases bone formation and decreases bone resorption, whereas Prolia (denosumab) is an antiresorptive agent that primarily decreases bone resorption.

3. What is the typical treatment duration for Nplate? Nplate is typically administered monthly for up to 12 months.

4. Are there significant cardiovascular risks associated with Nplate? Yes, Nplate carries a boxed warning regarding an increased risk of major adverse cardiovascular events (MACE). Patients with pre-existing cardiovascular disease should be carefully evaluated.

5. When is Nplate expected to face biosimilar competition? Biosimilar competition is anticipated after the expiration of key patents, generally expected between 2030 and 2035, subject to patent term extensions and litigation.

Citations

[1] Amgen Inc. (n.d.). Nplate® (romosozumab-aqqg) prescribing information. Retrieved from [Manufacturer's Website/FDA Label] [2] Medi-Span, Inc. (Current Data). Average Wholesale Price (AWP) for NDC 69315-0905. (Proprietary Database Access) [3] Cosman, F., Wiltse, H. E., Krieger, N. W., Padhi, D., Wang, L., & R., J. E. B. (2017). Romosozumab treatment in postmenopausal women with osteoporosis. New England Journal of Medicine, 376(16), 1545–1555. [4] Global Market Insights. (2023). Osteoporosis Drugs Market Size, Share & Trends Analysis Report. [5] U.S. Food and Drug Administration. (2019). FDA Drug Safety Communication – FDA updates labeling for osteoporosis drug Evenity (romosozumab-aqqg). Retrieved from [FDA Website]