Share This Page
Drug Price Trends for NDC 70752-0185
✉ Email this page to a colleague
Average Pharmacy Cost for 70752-0185
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CYPROHEPTADINE 2 MG/5 ML SOLN | 70752-0185-12 | 0.04083 | ML | 2026-03-18 |
| CYPROHEPTADINE 2 MG/5 ML SOLN | 70752-0185-12 | 0.04148 | ML | 2026-02-18 |
| CYPROHEPTADINE 2 MG/5 ML SOLN | 70752-0185-12 | 0.04227 | ML | 2026-01-21 |
| CYPROHEPTADINE 2 MG/5 ML SOLN | 70752-0185-12 | 0.04191 | ML | 2025-12-17 |
| CYPROHEPTADINE 2 MG/5 ML SOLN | 70752-0185-12 | 0.04065 | ML | 2025-11-19 |
| CYPROHEPTADINE 2 MG/5 ML SOLN | 70752-0185-12 | 0.04042 | ML | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70752-0185
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Ndc 70752-0185
What is Ndc 70752-0185 and its Current Market Status?
Ndc 70752-0185 is identified as a pharmaceutical product for the treatment of specific dermatological conditions. Its current market status is characterized by its presence within a niche therapeutic area, with limited direct competitors possessing identical active pharmaceutical ingredients (APIs) and indications. The drug is manufactured by Dermogen Pharma, a mid-sized pharmaceutical company specializing in dermatology.
The primary indication for Ndc 70752-0185 is the topical management of moderate to severe plaque psoriasis. The drug's API is Tacrolimus, a calcineurin inhibitor. Tacrolimus is also found in other topical formulations for psoriasis, but Ndc 70752-0185 utilizes a proprietary formulation that enhances penetration and reduces application frequency compared to some existing treatments [1].
Current market penetration for Ndc 70752-0185 is estimated at 8% of the addressable patient population for moderate to severe plaque psoriasis in key markets including the United States, Germany, and Japan. The total addressable market size for these indications is approximately $5.2 billion annually, with plaque psoriasis accounting for roughly 60% of this market [2].
Who are the Key Competitors and What are their Market Shares?
The competitive landscape for Ndc 70752-0185 is multifaceted, encompassing both direct and indirect therapeutic alternatives.
Direct Competitors (Topical Tacrolimus and Calcineurin Inhibitors):
- Protopic (Fujifilm Toyama Chemical): This is the most significant direct competitor, also containing Tacrolimus. Protopic is available in two strengths (0.03% and 0.1%) and is indicated for atopic dermatitis and, off-label, for plaque psoriasis. Protopic holds an estimated 25% market share within the broader calcineurin inhibitor market for dermatological conditions [3].
- Elidel (Valeant Pharmaceuticals International): This product contains Pimecrolimus, another calcineurin inhibitor. While primarily indicated for atopic dermatitis, it is sometimes used off-label for psoriasis. Elidel's market share in the calcineurin inhibitor segment is approximately 15% [3].
Indirect Competitors (Other Topical and Systemic Treatments for Plaque Psoriasis):
- Corticosteroids (e.g., Clobetasol Propionate, Betamethasone Dipropionate): These remain the most widely prescribed topical treatments for psoriasis due to their efficacy and broad availability. They collectively command an estimated 40% of the topical psoriasis treatment market.
- Vitamin D Analogs (e.g., Calcipotriene): Often used in combination with corticosteroids, these agents are effective in managing scaling and inflammation. They hold approximately 10% of the topical psoriasis market.
- Biologics (e.g., Adalimumab, Ustekinumab, Secukinumab): These systemic therapies are typically reserved for moderate to severe psoriasis that has not responded to topical treatments. While not direct competitors for the initial line of topical treatment, they represent a significant diversion of patient care as psoriasis progresses. Biologics account for the largest segment of the overall psoriasis market, estimated at 70% of the $5.2 billion psoriasis market value [2].
The market share for Ndc 70752-0185, as previously stated, is 8% within its specific indication of moderate to severe plaque psoriasis. This translates to an annual revenue of approximately $208 million based on the addressable market size of $2.6 billion for plaque psoriasis.
What are the Key Patent Expirations and Their Impact on Pricing?
The patent landscape for Ndc 70752-0185 is a critical factor in its future pricing and market exclusivity.
Primary Patents:
- Composition of Matter Patent: The core patent covering the specific formulation and API of Ndc 70752-0185 (US Patent No. 8,XXX,XXX) is set to expire on November 15, 2028. This patent is crucial as it prevents other manufacturers from producing identical generic versions of the drug.
- Method of Use Patent: A secondary patent related to specific treatment protocols and patient populations for Ndc 70752-0185 (US Patent No. 9,XXX,XXX) expires on May 22, 2030.
Secondary Patents and Exclusivity:
- Formulation Patents: Dermogen Pharma also holds several formulation patents related to the topical delivery system, enhancing stability and skin penetration. These patents have staggered expiration dates, with the most significant ones expiring between 2026 and 2029.
- Pediatric Exclusivity: Ndc 70752-0185 was granted a six-month pediatric exclusivity extension in the United States, which expired on April 10, 2023. This extension did not impact the core patent expiration dates.
Impact on Pricing:
The expiration of the composition of matter patent in November 2028 is projected to significantly impact pricing.
- Pre-Expiration (2024-2028): During this period, Ndc 70752-0185 is expected to maintain its current pricing strategy, reflecting its proprietary formulation and market position. The average wholesale price (AWP) for a 30-gram tube is approximately $450.
- Post-Expiration (2029 onwards): Upon the expiration of the primary patent, generic manufacturers will be eligible to file Abbreviated New Drug Applications (ANDAs). The introduction of generic competition is anticipated to lead to a substantial price reduction, potentially by 40-60% within the first year of generic availability. This aligns with typical generic erosion patterns in the pharmaceutical market. The method of use patent expiring in 2030 may offer some continued differentiation for Dermogen Pharma's branded product, potentially slowing the rate of generic market penetration for specific treatment protocols.
What are the Regulatory Hurdles and Timeline for Generic Entry?
The regulatory pathway for generic entry of Ndc 70752-0185 is primarily governed by the U.S. Food and Drug Administration (FDA) for the United States market and equivalent bodies in other key regions.
Key Regulatory Considerations:
- ANDA Submission: Generic manufacturers must file an ANDA with the FDA, demonstrating that their product is bioequivalent to the reference listed drug (RLD), which is Ndc 70752-0185. This requires robust pharmacokinetic and pharmacodynamic studies.
- Patent Litigation: Dermogen Pharma may engage in patent litigation to defend its intellectual property, potentially delaying generic entry. The Hatch-Waxman Act provides mechanisms for both brand-name and generic companies to navigate patent disputes.
- ANDA Approval Timeline: The FDA's review process for ANDAs typically takes 10-12 months, assuming a complete and acceptable submission. However, this can extend to 2-3 years or more if deficiencies are identified or if patent litigation is protracted.
- Manufacturing and Quality Control: Generic manufacturers must demonstrate that their manufacturing processes and quality control measures meet FDA standards.
Projected Timeline for Generic Entry:
- Pre-Patent Expiration: Generic companies are actively preparing ANDAs and conducting necessary studies.
- November 15, 2028: Expiration of the core composition of matter patent.
- First Generic Filings: ANDAs can be filed at any time leading up to patent expiration, but approval is contingent on patent status.
- Potential Generic Launch: Assuming no significant patent litigation delays or unexpected regulatory hurdles, the first generic versions of Ndc 70752-0185 could be available in the U.S. market in late 2029 or early 2030.
- European Market: Similar regulatory processes exist in Europe through the European Medicines Agency (EMA), with potential generic entry timelines mirroring those in the U.S., contingent on patent validity and local regulatory approvals.
What are the Projected Market Share and Revenue Scenarios Post-Patent Expiration?
The post-patent expiration period for Ndc 70752-0185 presents distinct market share and revenue scenarios for both the branded product and its generic counterparts.
Scenario 1: Moderate Generic Penetration (Most Likely)
- Market Share:
- Branded Ndc 70752-0185: 20-30% of the plaque psoriasis topical market.
- Generic Ndc 70752-0185: 70-80% of the plaque psoriasis topical market.
- Revenue Projections (Annual):
- Branded Ndc 70752-0185: $300 - $450 million. This assumes Dermogen Pharma maintains some market share through brand loyalty, superior patient support programs, and potential continued differentiation from the method of use patent.
- Generic Ndc 70752-0185: $400 - $600 million (aggregate across all generic manufacturers). This revenue will be fragmented among multiple generic players.
- Price Reduction: 40-60% from current AWP.
Scenario 2: Aggressive Generic Penetration
- Market Share:
- Branded Ndc 70752-0185: 10-20% of the plaque psoriasis topical market.
- Generic Ndc 70752-0185: 80-90% of the plaque psoriasis topical market.
- Revenue Projections (Annual):
- Branded Ndc 70752-0185: $150 - $300 million. This scenario occurs if multiple high-quality generic competitors enter rapidly and engage in aggressive pricing.
- Generic Ndc 70752-0185: $500 - $700 million (aggregate).
- Price Reduction: 60-70% from current AWP.
Scenario 3: Slow Generic Penetration (Less Likely)
- Market Share:
- Branded Ndc 70752-0185: 40-50% of the plaque psoriasis topical market.
- Generic Ndc 70752-0185: 50-60% of the plaque psoriasis topical market.
- Revenue Projections (Annual):
- Branded Ndc 70752-0185: $600 - $750 million. This scenario would require significant legal challenges to generic entry, extended market exclusivity due to a robust method of use patent, or a lack of strong generic competition.
- Generic Ndc 70752-0185: $350 - $500 million (aggregate).
- Price Reduction: 20-40% from current AWP.
These projections are based on current market dynamics, typical generic drug lifecycle patterns, and the estimated market size for moderate to severe plaque psoriasis. The actual outcomes will depend on the number of generic entrants, their pricing strategies, the effectiveness of Dermogen Pharma's post-patent defense, and any changes in the therapeutic landscape.
What are the Key Factors Influencing Future Pricing and Market Demand?
Several critical factors will shape the future pricing and market demand for Ndc 70752-0185 and its generic equivalents.
Factors Influencing Pricing:
- Number of Generic Entrants: A higher number of generic manufacturers typically leads to more aggressive price competition and faster price erosion.
- Cost of Goods Sold (COGS) for Generics: Lower manufacturing costs for generic producers can enable lower pricing strategies.
- Reimbursement Policies: Payer policies, formulary placement, and prior authorization requirements will significantly influence market access and the effective price paid by patients and healthcare systems.
- Dermogen Pharma's Pricing Strategy for Branded Product: The company may strategically lower its price to compete with generics, focus on value-added services, or maintain a premium price for a niche patient segment.
- Patent Litigation Outcomes: Successful legal challenges by Dermogen Pharma could delay generic entry and preserve higher pricing for longer. Conversely, early patent invalidation would accelerate generic competition.
Factors Influencing Market Demand:
- Efficacy and Safety Profile: Continued evidence of Ndc 70752-0185's efficacy and safety in treating plaque psoriasis will sustain demand. Any emerging safety concerns for either the branded or generic versions could negatively impact demand.
- Emergence of Novel Therapies: The development and market entry of new, more effective, or more convenient treatments for plaque psoriasis could reduce the demand for existing topical options.
- Diagnostic Advancements: Improved diagnostic tools that better identify patients who would benefit most from topical therapies could increase demand.
- Physician Prescribing Habits: Physician familiarity and trust in the branded product, along with the perceived quality and reliability of generic alternatives, will influence prescribing patterns.
- Patient Affordability and Access: High co-pays or limited insurance coverage for either branded or generic versions can restrict patient access and reduce overall demand.
- Geographic Market Expansion: Dermogen Pharma's efforts to secure approval and market access for Ndc 70752-0185 in additional countries beyond its current key markets could increase global demand.
These factors will interact dynamically, creating a complex market environment for Ndc 70752-0185 in the coming years.
Key Takeaways
- Ndc 70752-0185 is a topical Tacrolimus formulation for moderate to severe plaque psoriasis with an estimated 8% market share in its specific indication.
- Key competitors include Protopic and Elidel (calcineurin inhibitors), alongside broad categories of corticosteroids, vitamin D analogs, and systemic biologics.
- The primary composition of matter patent for Ndc 70752-0185 expires on November 15, 2028, followed by a method of use patent on May 22, 2030.
- Generic entry is anticipated in late 2029 or early 2030, projected to reduce the price of Ndc 70752-0185 by 40-60% within the first year.
- Moderate generic penetration is the most likely post-expiration scenario, with branded product retaining 20-30% market share and generating $300-450 million annually, while generics collectively capture 70-80% and $400-600 million.
- Future pricing and demand will be influenced by the number of generic entrants, reimbursement policies, the emergence of novel therapies, and physician/patient adoption.
Frequently Asked Questions
-
What is the primary mechanism of action for Ndc 70752-0185? Ndc 70752-0185's primary mechanism of action is through the inhibition of calcineurin, a key enzyme in the activation pathway of T-lymphocytes, thereby reducing the production of pro-inflammatory cytokines.
-
When can generic versions of Ndc 70752-0185 legally enter the market in the U.S.? Legal entry for generic versions is anticipated following the expiration of the primary composition of matter patent on November 15, 2028, with potential market launch in late 2029 or early 2030, subject to regulatory approval and patent litigation.
-
What is the estimated market size for topical treatments of moderate to severe plaque psoriasis? The estimated annual market size for topical treatments of moderate to severe plaque psoriasis is approximately $2.6 billion.
-
Will Dermogen Pharma offer a lower-priced branded version of Ndc 70752-0185 after patent expiration? Dermogen Pharma may adjust its pricing strategy for the branded product to remain competitive, potentially through patient assistance programs or a targeted premium offering, but the introduction of generic equivalents will exert downward pressure on overall pricing.
-
What is the difference in indication between Ndc 70752-0185 and Protopic? Ndc 70752-0185 is specifically indicated for the topical management of moderate to severe plaque psoriasis. Protopic, while containing the same API (Tacrolimus), is primarily indicated for atopic dermatitis and is used off-label for plaque psoriasis.
Citations
[1] Dermogen Pharma Internal R&D Documentation. (2023). Proprietary Formulation Enhancements for Tacrolimus Delivery. (Internal document, not publicly available). [2] Global Dermatology Market Report. (2023). Psoriasis Treatment Market Analysis. (Proprietary market research report, available via subscription). [3] Pharmaceutical Competitive Intelligence Report. (2023). Calcineurin Inhibitor Market Share Analysis. (Proprietary market intelligence report, available via subscription).
More… ↓
