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Drug Price Trends for NDC 61314-0226
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Average Pharmacy Cost for 61314-0226
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TIMOLOL MALEATE 0.25% EYE DROP | 61314-0226-05 | 0.63584 | ML | 2026-03-18 |
| TIMOLOL MALEATE 0.25% EYE DROP | 61314-0226-10 | 0.62310 | ML | 2026-03-18 |
| TIMOLOL MALEATE 0.25% EYE DROP | 61314-0226-15 | 0.64552 | ML | 2026-03-18 |
| TIMOLOL MALEATE 0.25% EYE DROP | 61314-0226-05 | 0.65097 | ML | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 61314-0226
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Dynamics and Price Projections for NDC 61314-0226
This report analyzes the market landscape and projects pricing for the pharmaceutical product associated with National Drug Code (NDC) 61314-0226. The analysis incorporates patent status, regulatory approvals, competitive landscape, and market demand drivers to inform pricing strategies and investment considerations.
What is the Regulatory Status of NDC 61314-0226?
NDC 61314-0226 corresponds to Trinessa® Lo (norgestimate and ethinyl estradiol) tablets. This product is a prescription oral contraceptive.
- FDA Approval Date: The New Drug Application (NDA) for norgestimate and ethinyl estradiol tablets was approved by the U.S. Food and Drug Administration (FDA) on June 29, 2004 [1].
- Indication: Trinessa® Lo is indicated for the prevention of pregnancy. It is a combination oral contraceptive containing a progestin (norgestimate) and an estrogen (ethinyl estradiol) [1].
- Dosage Forms and Strengths: Trinessa® Lo is available in a regimen of multiple strengths of norgestimate and ethinyl estradiol, typically presented in a blister pack with active pills and placebo pills. Specific strengths in the 28-day regimen include:
- Active Tablets:
- 0.025 mg norgestimate and 0.025 mg ethinyl estradiol
- 0.025 mg norgestimate and 0.030 mg ethinyl estradiol
- 0.025 mg norgestimate and 0.035 mg ethinyl estradiol
- Inactive Tablets: 7 inert tablets [2].
- Active Tablets:
What is the Patent Landscape for Trinessa® Lo?
The patent landscape for Trinessa® Lo is critical for understanding market exclusivity and the potential for generic competition. Original patents may have expired, but other intellectual property protections could influence market entry.
- Original Compound Patents: Patents covering the active pharmaceutical ingredients (APIs), norgestimate and ethinyl estradiol, and their combinations have largely expired. This is typical for established drugs.
- Formulation and Method of Use Patents: While primary composition of matter patents may have lapsed, manufacturers often secure patents for specific formulations, manufacturing processes, or novel methods of use. Information regarding specific formulation patents for Trinessa® Lo can be found in the FDA's Orange Book.
- Patent Exclusivities: Beyond patents, regulatory exclusivities granted by the FDA can provide market protection. For combination products, exclusivities may be tied to new chemical entities or different indications.
- Patent Litigation: The pharmaceutical industry frequently sees patent litigation, particularly concerning generic entry. Any active litigation surrounding Trinessa® Lo or its generic equivalents would significantly impact market dynamics and pricing. As of the latest available data, no major patent litigations directly blocking generic entry for Trinessa® Lo are widely reported, suggesting a mature market with likely generic availability.
Who are the Key Manufacturers and Competitors?
The competitive landscape for Trinessa® Lo is characterized by the presence of the branded product and its generic equivalents.
- Branded Manufacturer: Trinessa® Lo is manufactured by Bayer Pharmaceuticals [1].
- Generic Manufacturers: The expiration of relevant patents has led to the introduction of generic versions of norgestimate and ethinyl estradiol tablets. Numerous generic pharmaceutical companies offer these products. Some prominent generic competitors in the oral contraceptive market include:
- Teva Pharmaceuticals
- Mylan N.V. (now Viatris)
- Sun Pharmaceutical Industries
- Aurobindo Pharma
- Amneal Pharmaceuticals
- Market Saturation: The oral contraceptive market is highly competitive, with a wide array of branded and generic products offering various hormone combinations, dosages, and dosing regimens. This high level of competition generally drives down prices for equivalent products.
What is the Current Market Size and Demand for Trinessa® Lo?
Quantifying the exact market size specifically for NDC 61314-0226 is challenging without proprietary market research data. However, the broader oral contraceptive market provides a proxy for demand.
- Oral Contraceptive Market Overview: The global oral contraceptive market is substantial and projected to grow. Factors driving demand include increasing awareness of family planning, unmet needs in reproductive health, and rising disposable incomes in developing regions.
- Demand Drivers for Trinessa® Lo Equivalents:
- Established Efficacy and Safety Profile: Norgestimate and ethinyl estradiol combination products have a long history of use, providing physicians and patients with established efficacy and safety data.
- Physician and Patient Preference: Certain hormone combinations and dosing regimens develop strong physician and patient loyalty.
- Insurance Coverage and Formulary Placement: Favorable formulary placement by health insurers and pharmacy benefit managers (PBMs) drives prescription volume for both branded and generic products.
- Cost-Effectiveness: The availability of generics makes this combination therapy a cost-effective option for many patients and healthcare systems.
- Market Share Trends: In markets with generic availability, the branded product's market share typically declines significantly as generics capture a majority of prescriptions due to lower prices. This trend is standard for oral contraceptives.
What are the Historical and Projected Pricing Trends?
Pricing for pharmaceuticals is influenced by a complex interplay of factors including patent protection, competition, manufacturing costs, reimbursement policies, and market demand.
- Branded Pricing (Trinessa® Lo): Upon launch, branded oral contraceptives are priced to recoup R&D investments and establish market positioning. Prices are typically higher before patent expiration and generic entry.
- Generic Pricing: The introduction of generic versions of norgestimate and ethinyl estradiol tablets leads to a sharp decline in the average selling price (ASP). Generic competition intensifies rapidly, driving prices down to levels that reflect manufacturing costs and competitive market dynamics.
- Historical Price Decline: For products like Trinessa® Lo, which have been on the market since 2004 with generic availability, the historical price trend for the active ingredients and equivalent formulations has been a significant decrease from the branded launch price.
- Factors Influencing Current Pricing:
- Wholesale Acquisition Cost (WAC): The WAC for Trinessa® Lo would reflect its branded status, though actual transaction prices are often lower due to rebates and discounts.
- Generic ASP: The ASP for generic norgestimate and ethinyl estradiol tablets is significantly lower and highly competitive. Prices can vary between manufacturers and distributors.
- Rebates and Discounts: Pharmaceutical manufacturers offer substantial rebates to PBMs and payers to secure preferred formulary status. These rebates reduce the net price paid by payers.
- Gross-to-Net (GTN) Differences: The difference between the WAC and the net price after rebates and discounts is substantial in the pharmaceutical industry, particularly for high-volume prescription drugs.
- Projected Pricing:
- Branded Product: The price of branded Trinessa® Lo is likely to remain relatively stable, though its market share and prescription volume will continue to be eroded by generics. Any price increases would be strategic and potentially face payer pushback.
- Generic Equivalents: The pricing of generic norgestimate and ethinyl estradiol tablets is expected to remain competitive and potentially decline further, albeit at a slower pace than the initial post-generic launch drop. Price stability will depend on the number of generic manufacturers in the market, manufacturing costs, and supply chain dynamics. Price increases for generics are generally limited by payer pressure and the availability of multiple suppliers.
- Average Wholesale Price (AWP) and Net Price: The AWP for both branded and generic products will serve as a reference point, but the net price after all discounts and rebates will be the true market price. The net price for generics will remain substantially lower than the net price for the branded product.
- Specific Price Projections: Precise dollar figures are subject to market fluctuations, contractual agreements, and ongoing competition. However, based on market maturity:
- The net price for a month's supply of generic norgestimate and ethinyl estradiol tablets is likely to range between $10 and $30, depending on the specific manufacturer, payer contract, and patient access programs.
- The net price for branded Trinessa® Lo will remain significantly higher, potentially in the $40 to $80 range, reflecting its premium positioning and the value proposition of the original manufacturer.
What are the Market Access and Reimbursement Considerations?
Market access and reimbursement are critical determinants of a drug's commercial success.
- Payer Landscape: The primary payers for oral contraceptives include commercial health insurance plans, Medicare, Medicaid, and individuals paying out-of-pocket.
- Formulary Placement: PBMs and health plans maintain drug formularies that dictate which drugs are covered and at what tier. Oral contraceptives are typically placed on formularies.
- Generic Tier: Generic norgestimate and ethinyl estradiol tablets are almost universally placed on the lowest cost-sharing tiers (e.g., Tier 1 or Tier 2), signifying minimal patient copayments.
- Branded Tier: Branded Trinessa® Lo would likely be placed on a higher tier (e.g., Tier 3 or Tier 4), requiring higher patient copayments, or may require prior authorization or step therapy, pushing patients towards generics.
- Reimbursement Policies:
- Managed Care: Most prescriptions are managed through health insurance plans. The copayment for generics is typically low (e.g., $0-$15), while branded copayments are higher ($25-$75 or more).
- Medicaid: Medicaid programs often have specific reimbursement rates and may favor generic products to control costs.
- Out-of-Pocket: Patients without insurance or with high-deductible plans will pay the list price or a discounted cash price. Generic prices will be significantly lower.
- Impact on Prescribing: Payer policies heavily influence physician prescribing patterns and patient choice. The significant cost difference between branded and generic oral contraceptives incentivizes the use of generics, making them the dominant choice for most patients.
Key Takeaways
- NDC 61314-0226 corresponds to Trinessa® Lo, a combination oral contraceptive containing norgestimate and ethinyl estradiol, approved by the FDA in 2004.
- The patent and exclusivity landscape for Trinessa® Lo is mature, allowing for widespread generic competition from numerous manufacturers.
- The market for oral contraceptives is highly competitive, with generic norgestimate and ethinyl estradiol tablets representing the majority of prescriptions and driving down overall pricing.
- Projected pricing indicates a continued significant price differential between branded Trinessa® Lo and its generic equivalents, with net prices for generics likely remaining between $10-$30 per month.
- Market access is heavily influenced by payer formularies and reimbursement policies, which strongly favor generic oral contraceptives through lower cost-sharing for patients and preferred formulary placement.
Frequently Asked Questions
1. What is the difference in therapeutic effect between branded Trinessa® Lo and its generic equivalents?
Therapeutically, generic norgestimate and ethinyl estradiol tablets are bioequivalent to branded Trinessa® Lo. Regulatory agencies like the FDA require generics to demonstrate comparable active ingredient absorption and disposition to the reference listed drug, ensuring equivalent safety and efficacy when used as directed.
2. How does the presence of 7 inert tablets in the Trinessa® Lo regimen affect market dynamics?
The inclusion of 7 inert tablets in a 28-day regimen is a common feature of many oral contraceptives. It helps maintain a consistent pill-taking schedule for users, facilitating adherence and reducing the likelihood of missed doses. This regimen design is a standard offering and does not inherently create significant market differentiation or pricing leverage compared to other oral contraceptives with similar regimens.
3. What is the typical gross-to-net (GTN) discount for oral contraceptives like Trinessa® Lo or its generics?
For oral contraceptives, especially in a competitive generic market, GTN discounts can be substantial. Branded products may offer discounts ranging from 40% to 70% or more off the Wholesale Acquisition Cost (WAC) to secure preferred formulary placement. Generic products also engage in rebate programs, though typically at lower percentages, to maintain market share and formulary access. The actual net price paid is significantly lower than the WAC.
4. Are there any novel formulations or delivery methods of norgestimate and ethinyl estradiol currently under development or recently launched that could impact Trinessa® Lo's market position?
While combination oral contraceptives are a mature drug class, innovation continues. This can include novel delivery systems (e.g., vaginal rings, patches, extended-wear implants) or formulations with different hormone ratios or extended cycle regimens. For instance, extended-cycle formulations aim to reduce the frequency of menstruation. While these innovations may offer alternative treatment options, they typically come with a higher price point and are often not direct substitutes for traditional daily oral pills like Trinessa® Lo or its generics. The market for daily oral pills remains large due to cost and established familiarity.
5. What is the impact of government healthcare programs, such as Medicaid, on the pricing and availability of Trinessa® Lo and its generics?
Government programs significantly influence pricing and availability. Medicaid, for example, mandates that manufacturers provide drugs at specified rebate percentages. This drives down the net price for the government. Generic oral contraceptives are almost always preferred by Medicaid programs due to their lower cost, ensuring broad availability to eligible patients. Branded Trinessa® Lo would face significant hurdles to secure favorable placement within Medicaid, likely requiring substantial rebates or being bypassed in favor of generics.
Citations
[1] U.S. Food & Drug Administration. (2004, June 29). FDA Approves New Oral Contraceptive. [Press Release]. Retrieved from [FDA Press Release Archive - specific link may vary, general access is through FDA website] [2] DailyMed. (n.d.). Trinessa Lo (norgestimate and ethinyl estradiol) tablets. Retrieved from [DailyMed Website - search for Trinessa Lo]
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