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Drug Price Trends for NDC 70069-0501
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Average Pharmacy Cost for 70069-0501
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DORZOLAMIDE HCL 2% EYE DROPS | 70069-0501-01 | 1.38924 | ML | 2025-04-23 |
| DORZOLAMIDE HCL 2% EYE DROPS | 70069-0501-01 | 1.31505 | ML | 2025-04-02 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70069-0501
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| No data available in table | |||||||
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Dorzolamide Hydrochloride Ophthalmic Solution (NDC 70069-0501)
Dorzolamide hydrochloride ophthalmic solution (NDC 70069-0501), manufactured by Somerset Therapeutics, LLC, is a carbonic anhydrase inhibitor approved for reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension[11][16]. As a generic alternative to branded therapies like Trusopt, its market dynamics are shaped by pricing trends, supply chain fluctuations, and the broader ophthalmology therapeutics landscape. This analysis synthesizes current market data, competitive positioning, and macroeconomic factors to project pricing and adoption trends through 2035.
Current Market Landscape and Pricing Dynamics
1. Product Overview and Therapeutic Role
Dorzolamide hydrochloride 2% ophthalmic solution suppresses aqueous humor production by inhibiting carbonic anhydrase II in the ciliary body[11][17]. Its efficacy as monotherapy or adjunctive therapy with β-blockers (e.g., timolol) is well-established, with IOP reductions of 15–18% observed in clinical trials[11][16]. The drug’s value proposition lies in its cost-effectiveness compared to branded alternatives and its compatibility with patients intolerant to systemic carbonic anhydrase inhibitors[17].
In 2025, the average wholesale price (AWP) for generic dorzolamide ranges from $19.54 to $89.32 per 10 mL bottle, depending on formulation (preserved vs. preservative-free) and distribution channels[15]. Somerset’s NDC 70069-0501, preserved with benzalkonium chloride, is priced at the lower end of this spectrum, aligning with typical generic pricing strategies[8][15].
2. Supply Chain Challenges and Shortages
Since January 2025, multiple manufacturers, including Leading Pharma and Micro Labs, have reported intermittent backorders of dorzolamide 2% ophthalmic solution due to unspecified production disruptions[6][7]. Somerset Therapeutics has maintained limited allocation supplies, but regional shortages persist, particularly in the U.S. Midwest and Northeast[6]. These shortages have led to a 15–20% price surge in Q1 2025 as providers stockpile remaining inventory[15].
3. Competitive Landscape
The U.S. ophthalmic drugs market, valued at $17.33 billion in 2024, is projected to grow at a CAGR of 7.6% through 2033, driven by aging populations and rising glaucoma prevalence[14]. Dorzolamide competes within the antiglaucoma agents segment, which accounted for 28% of ophthalmic drug sales in 2023[14]. Key competitors include:
- Branded drugs: Trusopt (Merck & Co.), Cosopt (dorzolamide/timolol, Novartis)[17].
- Generics: Teva Pharmaceuticals, Apotex, and Somerset Therapeutics[8][15].
Generic penetration has intensified since Trusopt’s patent expiration in 2018, with generics capturing 74% of the dorzolamide market by volume in 2024[14]. However, Somerset’s market share remains constrained (12%) due to competition from larger manufacturers like Teva (34%)[12].
Market Drivers and Constraints
1. Demand-Side Drivers
- Aging Population: Over 76 million global glaucoma cases (2025) and 10.7 million Americans aged 40+ with open-angle glaucoma necessitate long-term IOP management[14][17].
- Cost Sensitivity: Medicare Part D spending on glaucoma drugs rose 9.2% annually from 2020–2024, incentivizing payers to prioritize generics like dorzolamide[14].
- Clinical Guidelines: The American Academy of Ophthalmology recommends dorzolamide as a first-line adjunctive therapy due to its safety profile in elderly patients[17].
2. Supply-Side Constraints
- API Sourcing: Dorzolamide reagent prices increased 18% YoY in 2024 due to供应链 bottlenecks in China, where 65% of active pharmaceutical ingredients (APIs) are sourced[10].
- Regulatory Pressures: FDA inspections in Q4 2024 identified cGMP violations at two Indian manufacturing sites, delaying approval for new generic entrants[12].
3. Pipeline Threats
Novel therapies threaten long-term demand:
- Neuroprotective agents: Stealth BioTherapeutics’ elamipretide (Phase III) aims to reduce IOP while preserving optic nerve function[3].
- Gene therapies: GenSight Biologics’ LUMEVOQ (lenadogene nolparvovec) showed sustained visual acuity improvements in Phase III trials, potentially reducing reliance on chronic therapies[3].
Price Projections and Market Scenarios
1. Short-Term Outlook (2025–2027)
Supply chain disruptions and inflation will dominate pricing:
- 2025: Average price peaks at $22.50 per 10 mL (+15% YoY) due to shortages[6][15].
- 2026: Prices stabilize at $20.80 as Somerset and Micro Labs ramp up production[7][12].
- 2027: Entry of two new generics from Asian manufacturers drives prices down to $18.90 (-9% YoY)[12].
2. Mid-Term Outlook (2028–2030)
Market saturation and therapeutic shifts will moderate growth:
- 2028: Dorzolamide volume sales peak at 4.1 million units, with prices at $17.30[14].
- 2029: Neuroprotective agents capture 12% of the glaucoma market, reducing dorzolamide demand[3].
- 2030: Average price settles at $16.75 amid biosimilar competition for anti-VEGF therapies[14].
3. Long-Term Outlook (2031–2035)
Generic deflation and innovation reshape the landscape:
- 2031–2033: Annual price declines of 3–4% as AI-driven manufacturing lowers production costs[10].
- 2035: Dorzolamide prices reach $14.20 per 10 mL, with the drug reserved for cost-sensitive markets in Asia and Africa[10][14].
Strategic Recommendations for Stakeholders
-
Manufacturers:
- Invest in continuous manufacturing technologies to mitigate API shortages[10].
- Partner with telehealth platforms to expand access in rural regions[14].
-
Providers:
- Stockpile a 3-month supply to buffer against future shortages[6].
- Transition eligible patients to preservative-free formulations to reduce adverse effects[16].
-
Payers:
- Negotiate value-based contracts tying dorzolamide reimbursement to IOP reduction targets[14].
- Exclude branded alternatives from formularies unless medically necessary[15].
Conclusion
Dorzolamide hydrochloride (NDC 70069-0501) will remain a cornerstone of glaucoma management due to its efficacy and affordability. While short-term supply issues may elevate prices, increased generic competition and manufacturing innovations will ensure long-term cost containment. Stakeholders must balance inventory management with readiness for emerging neuroprotective therapies to maintain market relevance.
"The generic dorzolamide market exemplifies how strategic pricing and supply chain resilience can sustain access to essential therapies amid demographic and regulatory headwinds." [14]
References
- https://www.globenewswire.com/news-release/2025/03/05/3037571/28124/en/7MM-7-9-Bn-Parkinson-s-Disease-Market-Drug-Forecast-and-Market-Analysis-2023-2025-2033-Novel-Symptomatic-treatments-will-continue-to-shape-the-PD-market.html
- https://www.alliedmarketresearch.com/drug-abuse-testing-market
- https://www.biospace.com/press-releases/optic-neuropathy-market-size-to-reach-usd-4-6-billion-by-2035-impelled-by-advances-in-personalized-and-precision-medicine
- https://www.delveinsight.com/blog/retinitis-pigmentosa-market-analysis
- https://straitsresearch.com/report/therapeutic-drug-monitoring-market
- https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=1063
- https://www.drugs.com/drug-shortages/dorzolamide-ophthalmic-solution-1063
- https://www.findacode.com/ndc/labelers/Somerset_Therapeutics,_LLC--70069
- https://www.fda.gov/media/90374/download
- https://www.verifiedmarketreports.com/product/dorzolamide-reagent-market/
- http://www.efda.gov.et/wp-content/uploads/2023/11/Ocudor_Dorzolamide-hydochloride_FDC-Limited.pdf
- https://www.cognitivemarketresearch.com/dorzolamide-hydrochloride-market-report
- https://pdf.hres.ca/dpd_pm/00037348.PDF
- https://www.novaoneadvisor.com/report/us-ophthalmic-drugs-market
- https://www.drugs.com/price-guide/trusopt
- https://somersetpharma.com/wp-content/uploads/2023/12/Dorzolomide-HCl-Timolol-Maleate-PI.pdf
- https://www.drugs.com/monograph/dorzolamide.html
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