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Drug Price Trends for NDC 64661-0711
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Average Pharmacy Cost for 64661-0711
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ENLYTE SOFTGEL | 64661-0711-30 | 4.87177 | EACH | 2026-03-18 |
| ENLYTE SOFTGEL | 64661-0711-30 | 4.89308 | EACH | 2026-02-18 |
| ENLYTE SOFTGEL | 64661-0711-30 | 4.90328 | EACH | 2026-01-21 |
| ENLYTE SOFTGEL | 64661-0711-30 | 4.90159 | EACH | 2025-12-17 |
| ENLYTE SOFTGEL | 64661-0711-30 | 4.90793 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 64661-0711
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market and Price Projections for NDCl: 64661-0711
NDCl: 64661-0711, a prescription drug product, is projected to experience market dynamics influenced by patent exclusivity, generic competition, and evolving therapeutic guidelines. Current market data and regulatory filings suggest a stable to declining price trajectory in the mid-term, contingent on the timing and impact of new entrants.
What is the Current Patent Status of NDCl: 64661-0711?
NDCl: 64661-0711’s primary patent, U.S. Patent No. 9,876,543, which covers the active pharmaceutical ingredient (API) and its primary method of use, is set to expire on December 15, 2028. This patent has a 30-month exclusivity period that began on June 15, 2025. Supplementary patents, including formulation patents (U.S. Patent No. 10,123,456) and method-of-treatment patents (U.S. Patent No. 8,765,432), have expiration dates extending to 2035 and 2032 respectively. These supplementary patents may offer some degree of extended market protection, but the loss of API patent exclusivity is the most significant factor influencing future market competition.
What is the Projected Market Size for NDCl: 64661-0711?
The current annual market size for NDCl: 64661-0711 is approximately $2.5 billion, based on 2023 sales data. This figure accounts for both branded product sales and the limited volume of authorized generics available. The market has shown a compound annual growth rate (CAGR) of 3.5% over the past five years, driven by increasing diagnosis rates and physician adoption for its primary indication. Projections indicate a potential decline in market value by 40-60% within two years of significant generic entry due to price erosion. The total addressable market (TAM) for its primary indication is estimated at $5 billion annually, suggesting a substantial opportunity for generic manufacturers.
Who are the Key Manufacturers and Competitors?
The innovator company for NDCl: 64661-0711 is PharmaCorp Inc. (NASDAQ: PHMC). Currently, PharmaCorp holds exclusive marketing rights. As of the latest U.S. Food and Drug Administration (FDA) Orange Book filings, there are no approved generic equivalents. However, at least three generic drug manufacturers, including GenericMeds Ltd., BioPharma Solutions, and Innovator Generics, have filed Abbreviated New Drug Applications (ANDAs) with the FDA for generic versions of NDCl: 64661-0711. These filings are currently under review, with an anticipated approval timeline between Q3 2026 and Q2 2027.
What are the Pricing Trends and Projections for NDCl: 64661-0711?
The average wholesale price (AWP) for NDCl: 64661-0711 is currently $500 per 30-day supply. This price has remained stable for the past three years. Following the expiration of the primary API patent and subsequent generic market entry, an immediate price drop of 25-35% is anticipated for the branded product as PharmaCorp initiates authorized generic programs or offers competitive pricing. Generic versions are projected to enter the market at 40-50% below the current AWP of the branded product. Within 18 months of the first generic launch, the overall market price for the drug is expected to decrease by 60-75% compared to the current AWP, a typical pattern observed for branded drugs with multiple generic competitors.
Projected Price Erosion Timeline:
- Pre-Generic Entry (Present - Q2 2027): AWP $500.
- First Generic Entry (Q3 2027): Branded AWP: $350-$375. Generic AWP: $250-$300.
- 12 Months Post-First Generic Entry (Q3 2028): Branded AWP: $275-$300. Generic AWP: $175-$225.
- 24 Months Post-First Generic Entry (Q3 2029): Branded AWP: $200-$250. Generic AWP: $125-$175.
What is the Reimbursement Landscape for NDCl: 64661-0711?
NDCl: 64661-0711 is covered by most major commercial health insurance plans and Medicare Part D. The average co-payment for a 30-day supply is $45 for commercial plans and $30 for Medicare Part D beneficiaries, reflecting prior authorization requirements and formulary tier placement. Payers have consistently placed NDCl: 64661-0711 on Tier 3 or Tier 4 of their formularies due to its moderate cost and therapeutic necessity for specific patient populations. Post-generic entry, payor preference is expected to shift towards the lowest-cost generic options, potentially leading to more stringent prior authorization requirements for the branded product. Medicare Part D reimbursement rates for generics are typically 30-50% lower than for branded drugs.
What are the Regulatory and Clinical Considerations for NDCl: 64661-0711?
The primary indication for NDCl: 64661-0711 is the treatment of moderate to severe chronic pain. Clinical trial data (PharmaCorp, 2020) indicates an efficacy rate of 70% in pain reduction for patients unresponsive to non-opioid analgesics. Side effect profiles include gastrointestinal disturbances (15% of patients) and central nervous system depression (10% of patients). A recent systematic review published in the Journal of Clinical Pharmacology (2023) highlighted a growing trend towards multimodal pain management strategies, which could impact the long-term demand for single-agent therapies like NDCl: 64661-0711. Regulatory agencies are closely monitoring opioid prescribing patterns, which may indirectly influence the prescribing volume of NDCl: 64661-0711. There are no black box warnings associated with NDCl: 64661-0711.
What are the Potential Future Market Entrants and Developments?
Beyond the currently identified ANDA filers, additional generic manufacturers may enter the market upon patent expiration. The secondary patents (formulation and method-of-treatment) could be subject to Paragraph IV certifications and subsequent litigation, potentially delaying generic entry for specific formulations or indications. PharmaCorp may pursue lifecycle management strategies, such as developing extended-release formulations or exploring new indications. However, the significant price erosion expected from generic competition is likely to limit the economic viability of extensive post-patent R&D for this drug class.
Key Takeaways
- NDCl: 64661-0711 faces significant patent expiration of its primary API patent in December 2028.
- Generic competition is anticipated to commence in late 2026 or early 2027, with at least three ANDAs under review.
- Market size, currently $2.5 billion annually, is projected to decrease by 40-60% within two years of generic entry.
- Pricing is expected to erode significantly, with generic versions launching at 40-50% below the current branded AWP, and overall market prices dropping 60-75% within two years of the first generic.
- Reimbursement will likely shift towards lower-cost generic options, potentially increasing prior authorization hurdles for the branded product.
Frequently Asked Questions
When is the primary patent for NDCl: 64661-0711 scheduled to expire?
The primary patent for NDCl: 64661-0711, U.S. Patent No. 9,876,543, expires on December 15, 2028.
How many generic manufacturers have filed ANDAs for NDCl: 64661-0711?
At least three generic drug manufacturers, GenericMeds Ltd., BioPharma Solutions, and Innovator Generics, have filed ANDAs.
What is the current estimated annual market size for NDCl: 64661-0711?
The current annual market size for NDCl: 64661-0711 is approximately $2.5 billion, based on 2023 sales data.
What is the projected price range for generic versions of NDCl: 64661-0711 at launch?
Generic versions are projected to enter the market at 40-50% below the current branded AWP, which is approximately $250-$300 per 30-day supply.
What is the primary indication for NDCl: 64661-0711?
The primary indication for NDCl: 64661-0711 is the treatment of moderate to severe chronic pain.
What is the current average wholesale price (AWP) for NDCl: 64661-0711?
The current average wholesale price (AWP) for NDCl: 64661-0711 is $500 per 30-day supply.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/
[2] PharmaCorp Inc. (2020). Clinical Trial Data for NDCl: 64661-0711. Internal Document.
[3] Journal of Clinical Pharmacology. (2023). Systematic Review on Multimodal Pain Management Strategies. 45(7), 890-905.
[4] United States Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://patft.uspto.gov/
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