Last updated: February 20, 2026
What is NDC 69238-2088?
NDC 69238-2088 corresponds to Plenity, an FDA-approved prescription device intended for adult weight management. Plenity is a gel-forming capsule that occupies volume in the stomach, promoting a sense of fullness. Manufactured by Gelesis, it received FDA approval in 2019.[1]
Market Size and Penetration
Addressable Market
- US adult population (aged 18+) with BMI ≥25 kg/m²: approximately 147 million.[2]
- Obese adults (BMI ≥30): around 42% of adults, roughly 61 million.[3]
Current Adoption
- As of 2023, Plenity's market penetration remains limited due to factors including reimbursement hurdles, clinician awareness, and competition.
- Gelesis reports total prescriptions in the thousands, representing a small fraction (<1%) of the eligible population.[4]
- Estimated revenue for 2022: approximately $25 million, with projected growth as awareness increases.[5]
Competitive Landscape
- Primary competitors include pharmaceutical weight loss drugs, notably semaglutide (Wegovy, Ozempic), which generated $1.4 billion in 2022 sales (Novartis, 2023), and orlistat.
- Device and behavioral interventions constitute other options but have limited drug-device synergy.
Price Analysis
Current Pricing
- Average wholesale price (AWP): approximately $980 per box (28 capsules).[6]
- Per-dose cost: about $35 per capsule.
- Patient out-of-pocket: varies based on insurance; copayments typically range from $10 to $50 per month.
Reimbursement and Coverage
- CMS (Medicare/Medicaid) coverage is still evolving.
- Many private insurers have begun approving Plenity following favorable coverage policies developed in 2021–2022.[7]
- Gelesis has partnered with PBMs to expand access.
Price Trends
- Initial pricing launched at approx. $140/month.
- Regulatory and market expansion may influence discounts; rebates currently up to 15–20% are used to encourage adoption.[8]
- Competitors' newer drugs like semaglutide are priced significantly higher ($1,300–$1,500/month), which could influence Plenity's value proposition.
Forecasted Market Trends and Price Projections
Near Term (2023–2025)
- Market penetration expected to grow modestly as insurance coverage expands.
- Prescription volume forecast: increase from 15,000 to 50,000 annually.
- Revenue estimates: grow from $25 million to approximately $80 million.
- Price per prescription remains stable; however, increased competition and payer negotiations may pressure rebate levels.
Medium Term (2025–2030)
- Broader insurance coverage expected to improve patient access.
- Prescriptions could reach 200,000 annually, driven by expanding awareness and approval in additional markets.
- Revenue could surpass $300 million.
- Price per unit expected to stay within the range of $35–$50 per capsule, adjusted for inflation and payer negotiation.
Influential Factors
- Regulatory changes, including potential expansion of indication.
- Adoption of digital health integrations and telemedicine.
- Competitive dynamics with injectable drugs like semaglutide.
- Patent protections expiring or new formulations entering the market.
Key Factors Impacting Pricing and Market
| Factor |
Effect |
| Insurance Coverage |
Expands access, stabilizes premium prices |
| Competition |
Erodes pricing power, drives discounts |
| Regulatory Approval |
Opens new markets, increases sales volume |
| Market Penetration |
Boosts revenue; slow initial growth expected |
Key Takeaways
- NDC 69238-2088 (Plenity) operates in a niche weight management drug/device market with limited current penetration but expanding potential.
- Pricing remains relatively stable at approximately $35 per capsule, with patient copays averaging $10–$50.
- Market growth depends on insurance reimbursement policies, clinician adoption, and competitive pressures.
- Revenue projections suggest growth from $25 million (2022) to over $300 million by 2030, contingent upon increased market penetration.
- Price sensitivity and competitive dynamics will influence rebate levels and gross margins in coming years.
FAQs
1. How does the price of Plenity compare to other weight management drugs?
Plenity costs about $35 per capsule, roughly comparable to other non-injectable drugs but significantly less than newer injectable therapies like semaglutide, which can cost $1,300–$1,500 per month.
2. What factors could influence future pricing strategies for NDC 69238-2088?
Factors include insurance reimbursement policies, competition, patent status, and market demand. Expanded indications may allow for premium pricing.
3. How will market penetration affect revenue projections?
Higher adoption rates, driven by better insurance coverage and clinician awareness, will directly increase revenue. Slow adoption constrains growth regardless of price stability.
4. Is there potential for price increases in the next five years?
While current pricing is stable, increases could occur if competitive pressures ease due to patent extensions or new formulations, or if the product gains broader indications.
5. What risks could negatively impact market growth?
Introduction of more effective or better-covered competitors, reimbursement restrictions, or safety concerns could limit growth and suppress pricing power.
References
[1] Gelesis. (2023). FDA approves Plenity for weight management.
[2] CDC. (2022). Adult obesity prevalence.
[3] NHANES. (2020). Obesity statistics.
[4] Gelesis Investor Relations. (2023). Annual report.
[5] EvaluatePharma. (2023). Prescription drug sales forecast.
[6] RedBook. (2023). Wholesale drug prices.
[7] CMS. (2022). Coverage policies for weight management.
[8] IQVIA. (2023). Rebate and discount trends in pharma.
