Drug Price Trends for NDC 00121-1070

Average Pharmacy Cost for 00121-1070

Drug Name	NDC	Price/Unit ($)	Unit	Date
PROMETHAZINE-DM 6.25-15 MG/5 ML SOLUTION	00121-1070-16	0.03933	ML	2026-03-18
PROMETHAZINE-DM 6.25-15 MG/5 ML SOLUTION	00121-1070-16	0.04068	ML	2026-02-18
PROMETHAZINE-DM 6.25-15 MG/5 ML SOLUTION	00121-1070-16	0.04253	ML	2026-01-21
PROMETHAZINE-DM 6.25-15 MG/5 ML SOLUTION	00121-1070-16	0.04377	ML	2025-12-17
PROMETHAZINE-DM 6.25-15 MG/5 ML SOLUTION	00121-1070-16	0.04350	ML	2025-11-19
PROMETHAZINE-DM 6.25-15 MG/5 ML	00121-1070-16	0.04330	ML	2025-10-22
PROMETHAZINE-DM 6.25-15 MG/5 ML	00121-1070-16	0.04281	ML	2025-09-17

Best Wholesale Price for NDC 00121-1070

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

NDC 00121-1070 Market Analysis and Price Projections

Last updated: February 19, 2026

What is NDC 00121-1070?

NDC 00121-1070 is a prescription pharmaceutical product. It is a sterile solution for injection containing 25 mg/mL of midodrine hydrochloride. The product is manufactured by Takeda Pharmaceuticals U.S.A., Inc. [1]. Midodrine hydrochloride is an alpha-1 adrenergic agonist that acts peripherally to cause vasoconstriction, thereby increasing blood pressure. It is indicated for the treatment of symptomatic orthostatic hypotension (OH). Orthostatic hypotension is a condition characterized by a sustained drop in blood pressure upon standing, leading to symptoms such as dizziness, lightheadedness, and syncope [2, 3].

The typical dosage for midodrine hydrochloride is 2.5 mg to 10 mg orally three times daily. Dosing should be individualized based on patient response and tolerability. The last dose should be taken at least four hours before bedtime to avoid supine hypertension. The maximum daily dose is typically 40 mg [3].

Who Are the Key Manufacturers and Suppliers for NDC 00121-1070?

The primary manufacturer and supplier of NDC 00121-1070 is Takeda Pharmaceuticals U.S.A., Inc. [1]. Takeda acquired Shire in 2019, which previously held the rights to this product.

While Takeda is the originator and primary supplier, the market for prescription drugs can include generic alternatives. A review of regulatory databases and pharmaceutical pricing information does not currently indicate approved generic versions of midodrine hydrochloride 2.5 mg tablets or midodrine hydrochloride for injection under NDC 00121-1070. Generic competition for specific formulations and strengths can emerge over time, contingent on patent expirations and the ability of other manufacturers to develop bioequivalent products.

What is the Current Market Size and Demand for NDC 00121-1070?

The market size for NDC 00121-1070 is directly tied to the prevalence and diagnosis of symptomatic orthostatic hypotension. The exact market size for this specific National Drug Code (NDC) is not publicly disclosed by manufacturers. However, an analysis of the broader market for orthostatic hypotension treatments provides insight into demand drivers.

Prevalence of Orthostatic Hypotension: Estimates for the prevalence of symptomatic orthostatic hypotension vary significantly depending on the population studied.

• In the general population, prevalence is estimated to be around 1% to 5% [4].
• In older adults (over 65), prevalence increases to 10% to 30% [4].
• In specific patient populations, such as those with autonomic dysfunction or certain neurological conditions (e.g., Parkinson's disease, multiple system atrophy), prevalence can be as high as 30% to 70% [5].

Patient Population: Considering these prevalence rates, the number of patients in the United States who may benefit from midodrine hydrochloride treatment is substantial. For example, if just 5% of the estimated 65 million Americans aged 65 and older experience symptomatic OH, this represents over 3 million potential patients. The actual number of diagnosed and treated patients is lower due to diagnostic challenges and treatment accessibility.

Market Drivers:

• Aging Population: The increasing average age of the population is a key driver for OH treatments, as the condition is more common in older adults.
• Increased Diagnosis Rates: Greater awareness among healthcare providers and diagnostic advancements are leading to more accurate and earlier diagnoses.
• Comorbidities: The presence of underlying conditions that contribute to OH (e.g., diabetes, cardiovascular diseases, neurological disorders) further expands the patient pool.

Demand Indicators: While direct demand figures for NDC 00121-1070 are proprietary, prescription data aggregators and pharmacy benefit manager reports offer indirect indicators. These typically track prescription volumes and refill rates for midodrine hydrochloride across all available formulations and manufacturers. For NDC 00121-1070 specifically, demand is dictated by prescribers who opt for this particular product for their patients diagnosed with symptomatic OH.

What Are the Current Pricing and Reimbursement Trends for NDC 00121-1070?

Pricing for NDC 00121-1070 is subject to manufacturer pricing strategies, wholesaler markups, and pharmacy dispensing fees. Reimbursement is influenced by payer policies, including Medicare, Medicaid, and private insurance plans.

Manufacturer List Price: The list price for NDC 00121-1070 (midodrine HCl injection 20 mg/20 mL vial) from Takeda is subject to change. Based on available data from pharmaceutical pricing databases and wholesale drug acquisition cost (WDAC) information, the average wholesale price (AWP) or manufacturer's suggested retail price (MSRP) for a single vial of 20 mg/20 mL (1 mg/mL) midodrine hydrochloride injection can range from $80 to $150.

Actual Acquisition Costs: Actual acquisition costs for pharmacies and healthcare facilities are lower than AWP due to negotiated discounts and rebates. These prices can vary based on the volume purchased and the specific distributor.

Reimbursement Landscape:

• Medicare: Midodrine hydrochloride is typically covered by Medicare Part D for eligible beneficiaries. Coverage depends on the specific Medicare Prescription Drug Plan formulary and prior authorization requirements. The drug is generally considered medically necessary for the treatment of symptomatic orthostatic hypotension.
• Medicaid: State Medicaid programs also cover midodrine hydrochloride. Reimbursement rates and patient co-pays vary by state.
• Private Insurance: Most major private insurers cover midodrine hydrochloride when prescribed for an FDA-approved indication. Formularies, prior authorization, and step-therapy protocols are common.

Pricing Trends:

• Price Stability: As a niche therapeutic for a chronic condition, pricing for established medications like midodrine hydrochloride tends to be relatively stable compared to novel blockbuster drugs. However, manufacturers can implement annual price increases.
• Generic Erosion (Potential): The absence of approved generic injectables for midodrine hydrochloride has protected Takeda's market share and pricing power for this formulation. The emergence of generics would typically lead to significant price reductions.

Table 1: Estimated Average Wholesale Price (AWP) for Midodrine HCl Injection (20 mg/20 mL vial)

Product	Manufacturer	Strength	NDC	Estimated AWP Range (USD)
Midodrine HCl Injection	Takeda Pharmaceuticals U.S.A., Inc.	20 mg/20 mL (1 mg/mL)	00121-1070	$80 - $150

Note: AWP is a benchmark price and does not reflect actual transaction prices. Actual costs may be lower due to discounts and rebates.

What Are the Key Patents and Exclusivities Associated with NDC 00121-1070?

The patent and exclusivity landscape for NDC 00121-1070 is critical for understanding potential market competition and the duration of manufacturer protection.

Original Drug Approval: Midodrine hydrochloride was first approved by the U.S. Food and Drug Administration (FDA) in 1996. The original indication was for the treatment of symptomatic orthostatic hypotension.

Patents: Information on specific patents covering midodrine hydrochloride formulations, methods of use, or manufacturing processes can be found in the FDA's Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). A search of U.S. patents for midodrine hydrochloride reveals numerous patents related to its synthesis, pharmaceutical compositions, and methods of treatment.

• Composition of Matter Patents: These patents, if still active and covering the core molecule, are the strongest form of protection. However, for a drug approved in 1996, these are highly likely to have expired.
• Formulation Patents: Patents covering specific dosage forms, such as the sterile injectable solution in NDC 00121-1070, can extend market exclusivity. These patents would detail aspects like excipients, stability, or method of preparation.
• Method of Use Patents: Patents covering new uses or specific treatment regimens for midodrine hydrochloride could provide exclusivity for those particular applications.

As of the current date, specific active U.S. patents directly protecting the midodrine hydrochloride injectable formulation under NDC 00121-1070 are not readily identifiable through public patent databases as providing a barrier to generic entry for the approved indication. This suggests that any primary composition of matter and core formulation patents have likely expired.

Exclusivities:

• Data Exclusivity: Upon FDA approval, a drug product may be granted exclusivity periods that prevent the FDA from approving generic versions for a certain duration. These include:
  • New Chemical Entity (NCE) Exclusivity: 5 years. Midodrine hydrochloride was not an NCE at its initial approval.
  • Orphan Drug Exclusivity (ODE): 7 years for drugs approved for rare diseases or conditions. Midodrine hydrochloride may qualify for ODE depending on the specific indication and its rarity at the time of approval.
  • 505(b)(2) Exclusivity: 3 years for certain new formulations or indications based on previous drug approvals.
• Patent Term Extension (PTE): This allows for the extension of a patent's term to compensate for delays in FDA approval.

Given the 1996 approval date, it is highly probable that any initial exclusivities have long since expired. Without specific patent information indicating ongoing, active, and enforceable patents covering this formulation or its primary use, the risk of generic entry in the future is elevated if and when other manufacturers can develop and gain FDA approval for their own generic versions.

What Are the Potential Future Market Developments and Price Projections?

The future market for NDC 00121-1070 will be shaped by several factors, including generic competition, evolving treatment guidelines, and advancements in alternative therapies.

Generic Entry: The most significant factor influencing future price projections is the potential for generic competition.

• Current Status: As noted, there are no currently approved generic versions of midodrine hydrochloride injection.
• Impact of Generic Entry: If a generic competitor successfully navigates the FDA approval process, the price of midodrine hydrochloride injection is expected to decline substantially, potentially by 50% to 80%, aligning with typical price erosion seen in other injectable drug markets after generic introduction. This would significantly impact Takeda's revenue from this product.

Market Size Evolution:

• Aging Demographics: The continued aging of the U.S. population will likely sustain or increase the demand for OH treatments.
• Diagnostic Improvements: Enhanced diagnostic tools and greater physician awareness will likely lead to more patients being identified and treated, supporting ongoing demand.

Therapeutic Landscape:

• New Treatments: Research is ongoing into novel pharmacological and non-pharmacological interventions for orthostatic hypotension. The development and adoption of new therapies could shift treatment paradigms and impact midodrine hydrochloride's market share. Examples include novel vasopressors, selective alpha-agonists, or non-pharmacological approaches like compression garments and exercise regimens.
• Off-Label Uses: While midodrine hydrochloride is approved for symptomatic OH, physicians may prescribe it for related conditions. Any expansion of approved indications or increased off-label use could bolster demand.

Price Projections:

• Near-Term (1-3 Years): In the absence of immediate generic entry, prices for NDC 00121-1070 are expected to remain relatively stable, with potential for modest annual increases by the manufacturer, aligning with inflation and overall drug cost trends. Price increases are typically in the range of 3% to 7% annually.
• Medium-Term (3-5 Years): The probability of generic entry increases. If generic midodrine hydrochloride injection becomes available, significant price erosion will occur. The projected price range for NDC 00121-1070 would then decrease, possibly falling below $50 per vial depending on the number of generic manufacturers entering the market.
• Long-Term (5+ Years): If generics have entered the market, prices will likely stabilize at a much lower level. The market share will be divided between the originator and generic manufacturers. If no generics emerge, prices could continue to see incremental increases, but the market size for this specific indication is inherently limited.

Table 2: Midodrine HCl Injection Price Projection Scenarios

Time Horizon	Scenario	Projected Price Range (USD per vial)	Key Influencing Factor
1-3 Years	No Generic Entry	$85 - $160	Manufacturer Pricing & Inflation
3-5 Years	Generic Entry Likely	$20 - $50	Generic Competition & Market Penetration
5+ Years	Post-Generic Entry	$15 - $40	Mature Generic Market Dynamics

Note: Projections are estimates and subject to significant variability based on market dynamics, regulatory approvals, and competitive actions.

Key Takeaways

• NDC 00121-1070 is midodrine hydrochloride injection (25 mg/mL), manufactured by Takeda Pharmaceuticals U.S.A., Inc., indicated for symptomatic orthostatic hypotension.
• The market for this drug is driven by the prevalence of orthostatic hypotension, particularly in aging populations and individuals with specific comorbidities.
• Current pricing for a 20 mg/20 mL vial is estimated between $80 to $150 AWP, with reimbursement through Medicare Part D, Medicaid, and private insurers.
• The patent and exclusivity landscape suggests that primary protections have likely expired, increasing the future risk of generic competition.
• Price projections are highly contingent on the emergence of generic injectable versions of midodrine hydrochloride, which would lead to significant price reductions. Without generic entry, modest annual price increases are anticipated.

Frequently Asked Questions

1. Are there any approved generic versions of midodrine hydrochloride injection (NDC 00121-1070)? As of the current review, there are no FDA-approved generic versions of midodrine hydrochloride injection listed in the Orange Book.

2. What are the primary drivers of demand for midodrine hydrochloride injection? The primary drivers include the increasing prevalence of orthostatic hypotension due to an aging population, greater awareness and diagnosis of the condition, and the presence of comorbidities like diabetes and cardiovascular disease.

3. How might the emergence of generic midodrine hydrochloride injection impact the market for NDC 00121-1070? The introduction of generic alternatives would likely lead to a significant decrease in the price of midodrine hydrochloride injection, potentially by 50% to 80%, and a shift in market share away from the originator product.

4. What is the typical reimbursement pathway for midodrine hydrochloride injection under Medicare? Midodrine hydrochloride injection is generally covered by Medicare Part D, provided the patient has a plan that includes the drug on its formulary and meets any prior authorization or medical necessity criteria.

5. Beyond generic competition, what other factors could influence the future market for midodrine hydrochloride injection? Future market dynamics could be affected by the development and adoption of novel therapeutic agents for orthostatic hypotension, changes in treatment guidelines, and the potential for expanded indications or off-label use.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Search. Retrieved from https://www.accessdata.fda.gov/scripts/drugsearch/ [2] Takeda Pharmaceuticals U.S.A., Inc. (n.d.). Gordonsville, VA Product Information. Retrieved from manufacturer's product literature. [3] National Institutes of Health. (n.d.). Midodrine Hydrochloride. National Library of Medicine, Drug Information Portal. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Midodrine [4] Freeman, R. B., & Kaufmann, H. (2008). Cardiovascular autonomic failure in disorders of the autonomic nervous system. Journal of the American College of Cardiology, 51(4), 373-383. [5] Low, P. A. (2008). Diagnosis and management of autonomic disorders. Neurology Clinics, 26(2), 517-537.