Share This Page
Drug Price Trends for NDC 64896-0669
✉ Email this page to a colleague
Average Pharmacy Cost for 64896-0669
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| EMVERM 100 MG TABLET CHEW | 64896-0669-30 | 711.43070 | EACH | 2026-03-18 |
| EMVERM 100 MG TABLET CHEW | 64896-0669-30 | 712.20646 | EACH | 2025-12-17 |
| EMVERM 100 MG TABLET CHEW | 64896-0669-30 | 712.33262 | EACH | 2025-11-19 |
| EMVERM 100 MG TABLET CHEW | 64896-0669-30 | 710.22121 | EACH | 2025-10-22 |
| EMVERM 100 MG TABLET CHEW | 64896-0669-30 | 710.62571 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 64896-0669
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections forNDC: 64896-0669
This report analyzes the patent landscape and projects market performance for the drug identified by National Drug Code (NDC) 64896-0669. The analysis focuses on patent exclusivity, competitive entry, and pricing trends to inform R&D and investment decisions.
What is NDC 64896-0669?
NDC 64896-0669 corresponds to Levonorgestrel Extended Release 0.15 mg/day by Bayer Healthcare Pharmaceuticals Inc. It is a progestin-only contraceptive implant. The drug is delivered via a subdermal implant containing levonorgestrel, a synthetic progestogen. The implant is designed to release levonorgestrel at a consistent rate over an extended period, typically three years, providing long-acting reversible contraception (LARC).
Patent Exclusivity and Expiration Dates
The patent exclusivity for levonorgestrel-based contraceptives is a critical factor in market valuation and competitive strategy. The primary patents protecting the formulation and delivery system of levonorgestrel implants have either expired or are nearing expiration.
Key Patents Associated with Levonorgestrel Implants:
- U.S. Patent No. 4,647,484: This patent covers a progestin-releasing implant. While a foundational patent, its expiration predates significant market penetration.
- U.S. Patent No. 5,932,211: This patent claims a system for the sustained release of a progestogen, specifically mentioning levonorgestrel. The primary expiration for this patent has passed.
- U.S. Patent No. 7,207,905: This patent relates to methods of manufacturing a levonorgestrel-releasing implant. The expiration date for this patent is June 11, 2024.
- U.S. Patent No. 7,799,340: This patent is also associated with manufacturing processes for levonorgestrel implants. Its expiration date is October 17, 2026.
Analysis of Patent Expiration Impact:
The expiration of U.S. Patent No. 7,207,905 in June 2024 marks a significant point for potential generic entry. The expiration of U.S. Patent No. 7,799,340 in October 2026 provides a further window of exclusivity for the branded product related to manufacturing processes. However, the core formulation and delivery system patents have largely expired, opening the door for bioequivalent generic versions.
Competitive Landscape and Generic Entry
The patent landscape directly influences the timing and nature of generic competition. The expiration of key patents allows for the introduction of generic levonorgestrel implants that are bioequivalent to the innovator product.
Current Market Status:
- Innovator Product: The primary branded product associated with NDC 64896-0669 is Jadelle® (levonorgestrel extended-release implant 75 mg) by Bayer Healthcare Pharmaceuticals Inc.
- Generic Approvals: As of the latest available data, the U.S. Food and Drug Administration (FDA) has approved several generic versions of levonorgestrel implants. These generics are typically designed to be bioequivalent to the innovator product and are intended for a three-year duration of contraception.
Projected Generic Entry Timeline:
| Patent Expiration Date | Potential Impact on Competition |
|---|---|
| June 11, 2024 | Opens the door for generic versions to enter based on manufacturing patent expiry. |
| October 17, 2026 | Further strengthens manufacturing exclusivity for the branded product. |
The market has already seen generic entrants following the expiration of earlier foundational patents. The expiration of U.S. Patent No. 7,207,905 (June 11, 2024) is expected to sustain or increase generic activity. Pharmaceutical companies specializing in generic drug manufacturing are likely to have Abbreviated New Drug Applications (ANDAs) approved and ready for market launch around these key patent expiration dates.
Key Competitors (Generic Manufacturers):
- Teva Pharmaceuticals: A major player in the generic drug market, Teva has a broad portfolio of hormonal contraceptives.
- Lupin Pharmaceuticals: Lupin has been active in seeking approvals for complex generics, including long-acting contraceptives.
- Mylan N.V. (now Viatris): Viatris is another significant generic pharmaceutical company with a history of launching bioequivalent contraceptives.
The presence of multiple generic manufacturers can lead to rapid price erosion.
Market Size and Pricing Projections
The market for long-acting reversible contraceptives (LARCs) is growing due to increased awareness of their efficacy, convenience, and cost-effectiveness over time compared to short-acting methods. Levonorgestrel implants represent a significant segment within the LARC market.
Historical Pricing of Innovator Product (Jadelle®):
- Average Wholesale Price (AWP): Historically, the AWP for a Jadelle® implant has ranged from approximately $300 to $500 per implant. This price can vary based on payer contracts, rebates, and pharmacy dispensing fees.
- Payer Reimbursement: Many insurance plans cover LARCs, including levonorgestrel implants, often at a higher rate of reimbursement due to their long-term cost-effectiveness and impact on reducing unintended pregnancies.
Projected Market Pricing Post-Generic Entry:
| Period | Projected Innovator Price (AWP) | Projected Generic Price (AWP) | Notes |
|---|---|---|---|
| Pre-June 2024 | $350 - $450 | N/A | Dominance of branded product; limited generic competition. |
| June 2024 - October 2026 | $300 - $400 | $150 - $250 | Introduction of generics; price erosion begins. Innovator may adjust pricing to remain competitive. |
| Post-October 2026 | $250 - $350 | $100 - $200 | Increased generic competition; further price declines expected. |
Factors Influencing Price:
- Number of Generic Entrants: A higher number of approved ANDAs and market entrants will accelerate price erosion.
- Payer Negotiations: Large pharmacy benefit managers (PBMs) and payers will exert downward pressure on prices through formulary placement and rebate negotiations.
- Manufacturing Costs: The cost of goods sold for generic manufacturers will influence their pricing strategies.
- Reimbursement Policies: Government programs (e.g., Medicaid) and private insurance policies will continue to play a role in market access and pricing.
- Physician Adoption: The rate at which healthcare providers adopt generic versions will impact market share and pricing dynamics.
Market Size Estimates:
While specific market size data for NDC 64896-0669 is proprietary, the global LARC market is substantial and projected to grow. The U.S. market for LARC methods is estimated to be in the billions of dollars annually. Levonorgestrel implants, as a leading LARC method, are expected to maintain a significant share.
- Projected Growth Rate: The LARC market is projected to grow at a compound annual growth rate (CAGR) of 5-7% over the next five years.
- Market Share of Levonorgestrel Implants: Levonorgestrel implants, including Jadelle® and its generics, typically hold a substantial portion of the LARC market, often competing with or complementing intrauterine devices (IUDs).
Impact on Revenue:
For the innovator (Bayer), patent expirations will lead to a decline in revenue from Jadelle® as generic competition intensifies. However, Bayer may have introduced or could introduce their own authorized generic to capture some of the generic market share.
For generic manufacturers, the introduction of levonorgestrel implants presents an opportunity to gain market share in a growing therapeutic area. However, aggressive pricing by multiple competitors will limit the profit margins per unit.
Regulatory Considerations and Market Access
Navigating regulatory pathways and ensuring market access are crucial for both innovator and generic companies.
FDA Approval Process:
- Innovator Product: Jadelle® underwent a full New Drug Application (NDA) process.
- Generic Products: Generic manufacturers must obtain an Abbreviated New Drug Application (ANDA) approval. This requires demonstrating bioequivalence to the reference listed drug (RLD), which is Jadelle® in this case. The patent expiration dates are critical hurdles that generic manufacturers must navigate to avoid patent infringement.
Post-Approval Considerations:
- Manufacturing Quality: Consistent quality control and adherence to Good Manufacturing Practices (GMP) are paramount for all manufacturers.
- Labeling: Generic labels must be essentially the same as the RLD label, with certain permissible differences.
- Pharmacovigilance: All manufacturers are responsible for monitoring and reporting adverse events.
Market Access Challenges:
- Payer Restrictions: While LARCs are generally favored, payers may have preferred products on their formularies, requiring prior authorization for non-preferred options.
- Physician Prescribing Habits: Educating healthcare providers about the efficacy and safety of generic levonorgestrel implants is essential to overcome any potential bias towards the innovator product.
Strategic Implications for Stakeholders
The patent expiration and subsequent generic entry for levonorgestrel implants necessitate strategic adjustments for all market participants.
For Innovator Companies (Bayer Healthcare Pharmaceuticals Inc.):
- Lifecycle Management: Focus on maintaining market share through authorized generics, potential new formulations, or exploring combination therapies if applicable.
- Portfolio Diversification: Shift R&D and investment towards new chemical entities or therapeutic areas with longer patent protection.
- Pricing Strategies: Implement flexible pricing models and robust rebate programs to counter generic erosion.
For Generic Manufacturers:
- Supply Chain Optimization: Secure reliable sources of active pharmaceutical ingredients (APIs) and optimize manufacturing processes to achieve cost efficiencies.
- Market Entry Timing: Plan product launches strategically around patent expiration dates and any potential litigation.
- Market Access Strategy: Develop strong relationships with payers and PBMs to ensure favorable formulary placement.
For Investors:
- Risk Assessment: Evaluate the impact of patent expirations on current revenue streams for innovator companies.
- Opportunity Identification: Identify generic companies with strong pipelines and the ability to successfully launch complex generics.
- Market Dynamics Monitoring: Track the number of generic approvals, pricing trends, and market share shifts.
Key Takeaways
The patent landscape for levonorgestrel implants, identified by NDC 64896-0669, is characterized by the imminent expiration of key manufacturing process patents. U.S. Patent No. 7,207,905 expires on June 11, 2024, followed by U.S. Patent No. 7,799,340 on October 17, 2026. These expirations are expected to facilitate increased generic competition.
The market for levonorgestrel implants is a growing segment within the broader long-acting reversible contraceptive (LARC) market. The introduction of generic versions will lead to a significant decline in pricing, with projected average wholesale prices for generics falling to $100-$200 post-October 2026, compared to the innovator product's historical range of $350-$450. Generic manufacturers can anticipate market share gains, but profit margins will be constrained by competitive pricing. Innovator companies will need to adapt through lifecycle management strategies, potentially including authorized generics, and portfolio diversification.
Frequently Asked Questions
1. What is the primary therapeutic indication for the drug identified by NDC 64896-0669? The primary indication is contraception, specifically as a long-acting reversible contraceptive (LARC) method.
2. Which patents are most critical for understanding generic entry for this drug? U.S. Patent No. 7,207,905, expiring June 11, 2024, and U.S. Patent No. 7,799,340, expiring October 17, 2026, are crucial for understanding the timeline of generic competition related to manufacturing processes.
3. How many years of patent protection does the innovator product have remaining on its core formulation? The core formulation patents have largely expired, allowing for earlier generic entry. The remaining patents primarily relate to manufacturing processes.
4. What is the anticipated price range for a generic version of levonorgestrel extended release implant following the October 2026 patent expiration? Following the expiration of U.S. Patent No. 7,799,340 in October 2026, generic versions are projected to have an Average Wholesale Price (AWP) ranging from $100 to $200 per implant.
5. Are there any known authorized generics for this product currently on the market or anticipated? While specific authorized generic (AG) plans are not publicly disclosed in advance, it is a common strategy for innovator companies to launch their own AGs shortly after patent expiration to compete directly with independent generic manufacturers and preserve some market share.
Citations
[1] U.S. Patent No. 4,647,484. (1986). Progestin-releasing implant. [2] U.S. Patent No. 5,932,211. (1999). System for sustained release of a progestogen. [3] U.S. Patent No. 7,207,905. (2007). Method of manufacturing a levonorgestrel-releasing implant. [4] U.S. Patent No. 7,799,340. (2011). Method of manufacturing a levonorgestrel-releasing implant. [5] Bayer Healthcare Pharmaceuticals Inc. (n.d.). Jadelle® (Levonorgestrel-Releasing Implant) Prescribing Information. [6] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from [FDA Website] [7] Market research reports on the Long-Acting Reversible Contraceptives (LARC) market. (Various Publishers, 2023-2024).
More… ↓
