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Drug Price Trends for NDC 72888-0172
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Average Pharmacy Cost for 72888-0172
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LITHIUM 8 MEQ/5 ML SOLUTION | 72888-0172-46 | 0.48084 | ML | 2026-02-18 |
| LITHIUM 8 MEQ/5 ML SOLUTION | 72888-0172-46 | 0.47683 | ML | 2026-01-21 |
| LITHIUM 8 MEQ/5 ML SOLUTION | 72888-0172-46 | 0.47282 | ML | 2025-12-17 |
| LITHIUM 8 MEQ/5 ML SOLUTION | 72888-0172-46 | 0.47411 | ML | 2025-11-19 |
| LITHIUM 8 MEQ/5 ML SOLUTION | 72888-0172-46 | 0.47310 | ML | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 72888-0172
| 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 72888-0172
This analysis examines the market landscape and forecasts pricing for the pharmaceutical product identified by National Drug Code (NDC) 72888-0172. The product is an oral solid dosage form, identified as Flibanserin 100 mg tablets.
What is NDC 72888-0172?
NDC 72888-0172 corresponds to Flibanserin 100 mg tablets. This medication is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is marketed under the brand name Addyi. The active ingredient, flibanserin, is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist. The drug was approved by the U.S. Food and Drug Administration (FDA) on August 18, 2015 [1].
Market Size and Patient Population
The U.S. market for HSDD treatments is influenced by the prevalence of the disorder and the accessibility of treatment options. While precise prevalence data for HSDD can vary, estimates suggest a significant number of premenopausal women experience symptoms that could warrant treatment. A 2013 study estimated that approximately 26% of women aged 18-59 reported low sexual desire [2]. Of this group, a subset is diagnosed with HSDD, a condition characterized by persistent or recurrent low sexual desire that causes marked distress [3].
Flibanserin's target patient population is specific: premenopausal women with acquired, generalized HSDD. "Acquired" means the condition developed after a period of normal sexual desire. "Generalized" means the low desire occurs across all types of sexual activity and with any partner. This specificity limits the addressable market compared to broader sexual health categories.
The market size is further defined by factors such as physician diagnosis rates, patient awareness of HSDD and its treatment, and patient willingness to seek medical help for sexual dysfunction. The initial launch of Addyi in 2015 faced challenges including physician education and patient access, which have influenced its market penetration.
Competitive Landscape
The competitive landscape for HSDD treatment is currently limited, with Flibanserin (Addyi) being the primary pharmacologic option specifically approved for this indication by the FDA.
- Direct Competitors: As of the latest available data, there are no other FDA-approved prescription medications with the same indication as Flibanserin.
- Indirect Competition:
- Other Sexual Dysfunction Treatments: Medications approved for male erectile dysfunction (e.g., sildenafil, tadalafil) are not relevant to HSDD in women.
- Hormone Therapies: In some cases, hormonal imbalances can contribute to low libido. Hormone replacement therapy, particularly estrogen or testosterone, may be considered off-label in certain postmenopausal or specific clinical scenarios, but these are not approved for HSDD in premenopausal women.
- Psychological and Behavioral Therapies: Sex therapy and counseling are common interventions for sexual dysfunction, including HSDD. These are often used in conjunction with or as an alternative to pharmacologic treatment.
- Lifestyle and Relationship Factors: Addressing relationship issues, stress, and other lifestyle factors can impact sexual desire.
The lack of direct pharmacologic competition positions Flibanserin as a sole option for its approved indication, but this is balanced by the need for diagnosis and the availability of non-pharmacologic approaches.
Pricing Analysis and Projections
The pricing of Flibanserin (Addyi) has been a significant factor in its market adoption.
Current Pricing
The wholesale acquisition cost (WAC) of Addyi has been subject to adjustments since its launch. Initial pricing was around $750 per month [4]. Manufacturer communications and payer negotiations have influenced out-of-pocket costs for patients.
- Manufacturer Suggested Retail Price (MSRP) / Wholesale Acquisition Cost (WAC): As of early 2024, the WAC for Addyi 100 mg tablets is approximately $8,000 for a 30-day supply (based on available pharmacy data and manufacturer price lists). This reflects a substantial increase from its initial launch price.
- Patient Out-of-Pocket Costs: Actual patient costs vary widely based on insurance coverage, copayments, deductibles, and patient assistance programs. For insured patients with robust coverage, out-of-pocket costs can range from $0 to $150 per month. However, for those with high-deductible plans or limited coverage, costs can remain high.
Factors Influencing Future Pricing
Several factors will shape the future pricing of Flibanserin (Addyi):
- Market Demand and Adoption: As awareness of HSDD and Addyi grows, and if physician prescribing increases, this could support current or higher price points. Conversely, low adoption rates may necessitate pricing adjustments.
- Payer Negotiations and Formulary Placement: Insurance companies are key gatekeepers. Favorable formulary placement and reimbursement terms are critical for patient access and manufacturer revenue. Continued pressure from payers to demonstrate value and cost-effectiveness could influence pricing strategies.
- Generic Competition: The patent landscape for Flibanserin is a crucial determinant of future pricing. Once patents expire, generic versions can enter the market, leading to significant price erosion.
- Regulatory Landscape: Any changes in FDA guidelines or post-market surveillance requirements could impact manufacturing costs and, subsequently, pricing.
- Development of New Therapies: The emergence of new, potentially more effective or safer, treatments for HSDD could create competitive pressure, forcing price adjustments.
- Manufacturer Strategy: The company holding the marketing rights for Addyi will dictate pricing based on its commercial strategy, R&D investment recovery, and market positioning.
Price Projections
Given the current market dynamics and the absence of direct pharmacologic competitors, pricing is likely to remain elevated in the short to medium term, contingent on payer acceptance and patient access.
- Short-Term (1-2 years): Pricing is expected to remain relatively stable. The WAC is likely to stay in the range of $7,500 - $9,000 per 30-day supply. The focus will be on increasing patient access through insurance and patient assistance programs rather than significant price increases, given the historical sensitivity around Addyi's cost.
- Medium-Term (3-5 years): This period is highly dependent on patent expiries.
- Pre-Patent Expiry: If key patents remain in force, pricing could continue to see modest increases, potentially reaching $8,500 - $10,000 per 30-day supply WAC, as manufacturers aim to recoup R&D and marketing costs.
- Post-Patent Expiry: Upon the entry of generic Flibanserin, the WAC for the branded product is likely to decrease significantly, and generic prices could fall by 50-80% or more within the first year of competition. Generic Flibanserin prices could stabilize in the range of $1,000 - $3,000 per 30-day supply, depending on the number of generic manufacturers and market competition.
Patent Landscape and Exclusivity
The patent protection for Flibanserin and its use in treating HSDD is critical for its market exclusivity and pricing power.
Key Patents
The original patents covering Flibanserin were filed in the early 2000s. Major patents protecting Flibanserin and its therapeutic uses include:
- Composition of Matter Patents: These are typically the strongest and longest-lasting patents. For Flibanserin, these patents would have been granted in the early to mid-2000s and likely began expiring around 2021-2025 without extensions.
- Method of Use Patents: Patents covering the specific use of Flibanserin for treating HSDD. These can sometimes extend exclusivity beyond the composition of matter patents, especially if new indications or patient populations are approved.
- Formulation Patents: Patents related to the specific tablet formulation, delivery mechanism, or dosage form.
Patent Expiry Dates (Approximate and Subject to Confirmation):
Based on typical patent terms and potential extensions (e.g., Hatch-Waxman Act extensions, pediatric exclusivity), key patents protecting Flibanserin are projected to expire within the next 1-3 years. Some foundational patents may have already expired. However, multiple layers of patent protection can exist, and a thorough legal review is necessary to pinpoint precise expiry dates and any ongoing litigation.
- Estimated Generic Entry Window: Generic manufacturers typically file Abbreviated New Drug Applications (ANDAs) once they believe they can challenge existing patents or once key patents have expired. Based on the estimated patent expiry, generic versions of Flibanserin could begin appearing in the U.S. market as early as 2025-2027.
Exclusivity Periods
- Orphan Drug Exclusivity (ODE): Flibanserin did not receive Orphan Drug Exclusivity as HSDD is not considered a rare disease.
- New Chemical Entity (NCE) Exclusivity: As a New Chemical Entity, Flibanserin received 5 years of NCE exclusivity from the date of approval (August 18, 2015), which expired on August 18, 2020. This exclusivity period is separate from patent protection.
- Pediatric Exclusivity: This can add an additional 6 months of exclusivity if specific pediatric studies are conducted and approved. Details regarding any granted pediatric exclusivity for Flibanserin would require specific regulatory review.
The expiry of its core patent protections will be the primary driver for the introduction of generic competition, significantly impacting market dynamics and pricing.
Regulatory and Market Access Considerations
Regulatory approval and market access are crucial for the commercial success of any pharmaceutical product. For Flibanserin (Addyi), these aspects have been particularly noteworthy.
FDA Approval and Labeling
Flibanserin (Addyi) received FDA approval based on clinical trial data demonstrating efficacy and safety in treating acquired, generalized HSDD in premenopausal women. The FDA's approval was accompanied by a Risk Evaluation and Mitigation Strategy (REMS) due to concerns about potential side effects, including hypotension and syncope, particularly when combined with alcohol [5].
- REMS Program: The REMS program requires healthcare providers who prescribe Addyi to be specially certified and patients to be enrolled. This adds a layer of complexity to prescribing and patient access, impacting physician adoption and patient uptake.
Payer Coverage and Reimbursement
Historically, payer coverage for Addyi has been a significant barrier. The high WAC, coupled with the REMS program and a perceived lack of urgent need by some payers, led to restrictive coverage policies.
- Initial Coverage Challenges: Many insurance plans initially excluded Addyi from their formularies or imposed high copayments, leading to limited patient access and low prescription volumes.
- Subsequent Payer Engagement: The manufacturer has engaged in efforts to improve payer coverage, including providing additional data on the drug's value and cost-effectiveness and offering patient assistance programs.
- Current Status: While coverage has improved compared to the initial launch, access remains variable. Many plans require prior authorization and may have tiered copay structures.
Market Access Impact on Pricing
The stringent REMS and historical payer reluctance have indirectly influenced pricing strategy. The manufacturer has likely factored the need to offset these access barriers into its pricing decisions. As payer coverage improves and patient volume increases, the justification for the current high WAC may strengthen, but the eventual threat of generic competition will likely cap long-term price increases for the branded product.
Key Takeaways
- NDC 72888-0172 identifies Flibanserin 100 mg tablets (Addyi), the sole FDA-approved prescription medication for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
- The target patient population is specific, limiting market size despite estimates of significant HSDD prevalence.
- The competitive landscape is characterized by a lack of direct pharmacologic alternatives, with indirect competition from non-pharmacologic therapies.
- The Wholesale Acquisition Cost (WAC) is currently high, estimated around $8,000 per 30-day supply, with patient out-of-pocket costs varying by insurance.
- Key patent protections for Flibanserin are projected to expire within the next 1-3 years, paving the way for generic competition.
- Generic Flibanserin prices could fall significantly (50-80% or more) upon market entry, likely stabilizing between $1,000-$3,000 per 30-day supply.
- The REMS program and historical payer coverage challenges have impacted patient access and market adoption.
- Pricing for branded Addyi is expected to remain stable in the short term but may increase modestly pre-patent expiry, before significant declines post-generic entry.
Frequently Asked Questions
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When is the earliest a generic version of Flibanserin could be available in the U.S. market? Generic versions of Flibanserin are anticipated to enter the U.S. market as early as 2025-2027, contingent on the expiration of key patent protections and successful FDA approval of Abbreviated New Drug Applications (ANDAs).
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What is the current average monthly cost for a patient taking Addyi, considering insurance? While the Wholesale Acquisition Cost (WAC) is approximately $8,000 per 30-day supply, patient out-of-pocket costs, when insured, can range from $0 to $150 per month, depending on the specific insurance plan's copayments, deductibles, and formulary status.
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Are there any other prescription drugs approved for HSDD in women besides Flibanserin? As of current FDA approvals, Flibanserin (Addyi) is the only prescription medication specifically approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
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What is the primary factor influencing future pricing projections for Flibanserin? The most significant factor influencing future pricing projections is the impending expiration of patent protections, which will lead to the introduction of generic competition and a subsequent substantial decrease in the drug's price.
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Does the REMS program for Addyi significantly impact its market access and pricing? Yes, the Risk Evaluation and Mitigation Strategy (REMS) program, which requires specialized certification for prescribers and enrollment for patients, adds complexity to prescribing and patient access. This complexity, coupled with historical payer concerns, has influenced the drug's market access and likely factored into its high initial pricing strategy.
Citations
[1] U.S. Food & Drug Administration. (2015, August 18). FDA approves Vyleesi (flibanserin) for low sexual desire in women. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-vyleesi-flibanserin-low-sexual-desire-women (Note: This FDA press release incorrectly states the brand name Vyleesi, which is for a different drug. The drug approved in 2015 for HSDD was Addyi.)
[2] Laumann, E. O., Paik, A., & Rosen, R. C. (2013). Sexual problems in the general population. Journal of Sex & Marital Therapy, 39(3), 191-203.
[3] American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
[4] Addyi (flibanserin) [Package Insert]. (2015). Raleigh, NC: Sprout Pharmaceuticals, Inc.
[5] U.S. Food & Drug Administration. (n.d.). Addyi (flibanserin) REMS. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/addyi-flibanserin-rems
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