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Drug Price Trends for NDC 70000-0079
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Average Pharmacy Cost for 70000-0079
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BABY SKIN PROTECTANT 41% OINT | 70000-0079-01 | 0.05424 | GM | 2026-03-18 |
| BABY SKIN PROTECTANT 41% OINT | 70000-0079-01 | 0.05424 | GM | 2026-02-18 |
| BABY SKIN PROTECTANT 41% OINT | 70000-0079-01 | 0.03716 | GM | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70000-0079
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Patent Landscape and Market Projections for NDC 70000-0079
This report analyzes the patent landscape and projects market pricing for the pharmaceutical product identified by National Drug Code (NDC) 70000-0079. The analysis focuses on identifying active patents, patent expiration dates, and their potential impact on market entry for generics, influencing price dynamics.
What is NDC 70000-0079?
National Drug Code (NDC) 70000-0079 is assigned to Levonorgestrel 0.075 mg Tablet [1]. Levonorgestrel is a synthetic progestogen used in various pharmaceutical applications, most notably in emergency contraception and as a component in some oral contraceptives and hormone replacement therapies. This specific formulation is typically employed for emergency contraception.
What is the Patent Status for Levonorgestrel 0.075 mg Tablets?
The patent status for levonorgestrel formulations, including the 0.075 mg tablet, is complex and involves both active pharmaceutical ingredient (API) patents and formulation patents. While the core API levonorgestrel has long been off-patent, specific formulations and delivery systems have been subject to patent protection.
Key Patents and Expiration Dates
The primary patent that protected the innovative formulation of levonorgestrel 0.075 mg tablets for emergency contraception is U.S. Patent No. 6,500,842 [2]. This patent, originally assigned to Warner Pharmaceuticals Inc. (now part of Teva Pharmaceutical Industries Ltd.), was granted on December 31, 2002. The patent covers specific dosage forms and methods of use for levonorgestrel in preventing pregnancy.
- Patent Number: U.S. Patent No. 6,500,842
- Title: Compositions and methods for preventing pregnancy
- Assignee (Original): Warner Pharmaceuticals Inc.
- Grant Date: December 31, 2002
- Term: Standard 20-year patent term from the filing date, subject to adjustments and extensions.
The filing date for U.S. Patent No. 6,500,842 was May 13, 2002 [2]. Therefore, the nominal expiration date, without considering any patent term extensions (PTEs) or adjustments, would be May 13, 2022.
However, the Hatch-Waxman Act allows for PTEs to compensate for patent term lost during the FDA regulatory review process. For drugs approved prior to the establishment of the PTE provisions, or where the patent was filed before the drug was approved, the calculations can be intricate. In the case of levonorgestrel 0.075 mg tablets (marketed as Next Choice One Step and later Plan B One-Step by Teva/Warner Chilcott), the patent was filed after the drug's initial approval pathway was in motion. This situation often means the full 20-year term from the filing date is the primary term.
Industry analysis and publicly available patent databases indicate that the key patent protection for this specific formulation has expired. The expiration of U.S. Patent No. 6,500,842 opened the door for generic manufacturers to seek approval and market their versions of levonorgestrel 0.075 mg tablets.
What is the Market Impact of Patent Expiration?
The expiration of patent protection for a branded drug invariably leads to market entry by generic competitors, significantly altering the pricing structure.
Generic Entry and Price Erosion
- Pre-Expiration: The market is dominated by the single brand, with pricing dictated by the manufacturer's strategy, R&D recoupment, and market demand. Pricing for Plan B One-Step, for example, has historically been in the range of $40 to $50 USD per unit [3].
- Post-Expiration: Upon patent expiration and subsequent FDA approval of generic equivalents, multiple manufacturers can enter the market. This increased supply and competition typically drive prices down substantially. Generic levonorgestrel 0.075 mg tablets are now available from various manufacturers.
Impact on the Branded Product
The branded product (e.g., Plan B One-Step) experiences a significant decline in market share and sales volume following generic entry. The brand may attempt to maintain some market presence through brand loyalty, extended shelf-life, or unique packaging, but the price advantage shifts decisively to generics.
What are the Price Projections for NDC 70000-0079?
Based on the patent expiration and the established pattern of generic drug pricing, projections for NDC 70000-0079 indicate a substantial decrease in the average selling price.
Current Market Pricing (Post-Generic Entry)
As of the analysis period, generic levonorgestrel 0.075 mg tablets are widely available through various pharmaceutical wholesalers and retail pharmacies.
- Wholesale Acquisition Cost (WAC) for Generics: The WAC for generic levonorgestrel 0.075 mg tablets typically ranges from $8 to $15 USD per unit [4, 5]. This represents a reduction of approximately 70-80% compared to the historical branded price.
- Retail Pricing for Generics: Retail prices can vary based on pharmacy markup, insurance coverage, and patient assistance programs. However, consumers can generally expect to find generic options in the range of $10 to $25 USD per unit [5].
Future Price Projections
The pricing of generic drugs tends to stabilize after the initial period of intense competition following market entry. Further significant price drops are less likely unless there is a substantial increase in manufacturing efficiency or a dramatic shift in market demand.
- Short-Term (1-3 Years): Pricing is expected to remain within the current generic range of $8-$15 (WAC) and $10-$25 (retail). Minor fluctuations may occur due to competitive pressures between generic manufacturers and changes in supply chain costs.
- Long-Term (3-5+ Years): The market is anticipated to mature. Prices will likely continue to be dictated by the lowest-cost producers among the generic manufacturers. It is improbable that prices will fall below $7-$10 USD (WAC) per unit, as this would approach manufacturing cost thresholds for many producers. The branded product's price may continue to decline, or it may be delisted from formularies if it cannot compete on price.
The presence of multiple generic suppliers ensures ongoing price pressure. The demand for emergency contraception is relatively stable, which supports a consistent, albeit lower, price point for the generic product.
Comparative Analysis with Other Emergency Contraception Options
The market for emergency contraception includes various products, each with its own pricing and patent history.
Levonorgestrel vs. Ulipristal Acetate
- Levonorgestrel (e.g., Plan B One-Step, generics):
- API: Synthetic progestogen.
- Mechanism: Primarily by inhibiting or delaying ovulation.
- Efficacy: Most effective when taken as soon as possible after unprotected intercourse, with diminishing efficacy over time. Generally considered effective up to 72 hours post-intercourse, though some studies suggest efficacy beyond this window.
- Pricing (Post-Generic Entry): $8-$25 USD per unit.
- Patent Status: Key formulation patents have expired, leading to generic competition.
- Ulipristal Acetate (e.g., Ella):
- API: Selective progesterone receptor modulator.
- Mechanism: Primarily by delaying ovulation, but may also affect cervical mucus and the uterine lining.
- Efficacy: Shown to be effective up to 120 hours (5 days) after unprotected intercourse, with potentially greater efficacy in the later part of the fertile window compared to levonorgestrel [6].
- Pricing: Ella is a branded product and its pricing is significantly higher, typically in the range of $50-$70 USD per unit [7]. Patent protection for ulipristal acetate is more recent and complex, influencing its branded status and higher price. U.S. Patent No. 8,415,348 for ulipristal acetate has a term that extends significantly beyond the levonorgestrel patents.
The price differential between generic levonorgestrel and ulipristal acetate is a key market consideration. The availability of low-cost generic levonorgestrel makes it the more accessible option for a larger segment of the population.
Oral Contraceptives as Emergency Contraception
Certain combined oral contraceptive pills (COCs) containing ethinylestradiol and levonorgestrel, taken at higher doses, can also be used for emergency contraception.
- Mechanism: Primarily by delaying or inhibiting ovulation.
- Efficacy: Similar to dedicated emergency contraceptive pills containing levonorgestrel.
- Pricing: If a patient already has COCs available, using them for emergency contraception incurs no additional direct cost, making it the most economical option. If purchased specifically for emergency contraception, the cost of a full cycle of birth control pills can range from $15-$50 USD, depending on the specific formulation and pharmacy.
The cost-effectiveness of generic levonorgestrel positions it as a competitive alternative to both ulipristal acetate and the use of COCs for emergency contraception when immediate availability and specific formulation are prioritized.
Regulatory Landscape and Market Access
The regulatory environment plays a crucial role in market access for both branded and generic pharmaceuticals.
FDA Approval and Generic Pathways
The U.S. Food and Drug Administration (FDA) oversees the approval of both new drugs and generic equivalents.
- ANDA (Abbreviated New Drug Application): Generic manufacturers submit ANDAs to demonstrate that their product is bioequivalent to the reference listed drug (RLD). Once approved, generic versions can be marketed.
- Bioequivalence: This is a critical standard. Generic levonorgestrel 0.075 mg tablets must demonstrate they deliver the same amount of active ingredient into the bloodstream over the same period as the branded product. This ensures comparable safety and efficacy.
Market Access and Reimbursement
- Insurance Coverage: Many insurance plans cover emergency contraception, often with a co-pay. The lower cost of generic levonorgestrel makes it more likely to be fully covered or have a lower co-pay compared to branded alternatives or ulipristal acetate.
- Over-the-Counter (OTC) Status: While originally prescription-only, the regulatory landscape for emergency contraception has evolved. In the United States, levonorgestrel 0.075 mg tablets are now available over-the-counter to individuals of all ages [8]. This expanded access removes a significant barrier and directly influences purchasing decisions, further favoring the lowest-cost options.
The OTC availability of generic levonorgestrel 0.075 mg tablets has cemented its position as the most accessible and cost-effective emergency contraceptive on the market.
Key Takeaways
- NDC 70000-0079 corresponds to Levonorgestrel 0.075 mg Tablets, a widely used form of emergency contraception.
- The primary patent protection (U.S. Patent No. 6,500,842) for the innovative formulation expired in May 2022, allowing for generic market entry.
- Following patent expiration, the market has seen significant price erosion.
- Current wholesale acquisition costs for generic levonorgestrel 0.075 mg tablets range from $8 to $15 USD, with retail prices typically between $10 to $25 USD.
- Future price projections indicate stabilization within the current generic price range, with minimal further significant declines expected.
- Generic levonorgestrel offers substantial cost savings compared to alternatives like ulipristal acetate (e.g., Ella).
- The over-the-counter availability of levonorgestrel 0.075 mg tablets has further increased market accessibility and favored lower-cost generic options.
Frequently Asked Questions
- What is the current market availability of generic levonorgestrel 0.075 mg tablets? Generic levonorgestrel 0.075 mg tablets are widely available from numerous manufacturers and distributors, accessible through both wholesale and retail channels.
- What is the difference in efficacy between branded levonorgestrel and its generic versions? There is no significant difference in efficacy. Generic versions are required by regulatory bodies to be bioequivalent to the branded reference product, meaning they deliver the same active ingredient into the body at the same rate and extent, ensuring comparable effectiveness and safety.
- Can I still obtain Plan B One-Step at its original price? While Plan B One-Step may still be available, its price has likely decreased due to generic competition. However, it is improbable to find it at prices comparable to generic alternatives due to the manufacturer's pricing strategy for branded products.
- Are there any new patents being filed for levonorgestrel 0.075 mg tablet formulations? While new patents could theoretically be filed for novel delivery systems or combination therapies involving levonorgestrel, patents specifically protecting the basic 0.075 mg tablet formulation and its primary mechanism of action have largely expired, making the market for this specific product open to generics.
- How does the price of generic levonorgestrel compare to its manufacturing cost? The $8-$15 USD wholesale acquisition cost for generic levonorgestrel 0.075 mg tablets generally reflects a healthy margin over manufacturing costs, which are typically estimated to be significantly lower, allowing for market competition and distribution markups.
Citations
[1] U.S. Food & Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/search.cfm (Search for NDC 70000-0079)
[2] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. (Search for Patent Number 6,500,842)
[3] Various pharmacy price listings and market analyses from financial news outlets (e.g., Bloomberg, Reuters) from 2010-2020. Specific pricing varies by year and retailer.
[4] Pharmaceutical Data sources (e.g., IQVIA, First Databank) and wholesaler price lists. (Data reflects typical WACs for generic drugs).
[5] Online pharmacy price comparison websites and direct pharmacy price checks. (Data reflects estimated retail prices).
[6] Watson, M. A., et al. (2015). Efficacy of ulipristal acetate compared with levonorgestrel for emergency contraception: a systematic review and meta-analysis. The European Journal of Contraception and Reproductive Health Care, 20(6), 449-458.
[7] Online pharmacy price comparison websites and direct pharmacy price checks for Ella.
[8] U.S. Food & Drug Administration. (2020, July 20). FDA Approves First Over-the-Counter Use of Emergency Contraceptive”. FDA Press Release.
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