Last updated: March 1, 2026
What is NDC 72603-0121?
NDC 72603-0121 is the National Drug Code identifying a specific pharmaceutical product. The code corresponds to Xulane (Ethinyl Estradiol and Noregestimate transdermal system), a hormonal contraceptive patch manufactured by Janssen Pharmaceuticals. It is indicated for pregnancy prevention and is administered weekly.
Market Overview
Market Size
The global contraceptive market was valued at approximately $20 billion in 2022. Transdermal contraceptives account for roughly 10% of this market, with Xulane representing a significant portion in the US market.
Key Competitors
- Ortho Evra (approved but discontinued)
- Twirla (Lnicera) — a patch similar to Xulane
- Oral contraceptives (e.g., Yaz, Yasmin)
- Intrauterine devices (IUDs)
Market Penetration
Xulane holds around 10-15% of the hormonal contraception market in the US, with steady growth driven by patient preference for non-oral delivery and convenience.
Revenue Trends
- In 2022, estimated US sales of Xulane totaled approximately $150 million.
- The product experienced a compound annual growth rate (CAGR) of approximately 3-5% over the past five years.
- Prescription volumes have increased 2-4% annually, with shifts favoring patches over pills due to compliance factors.
Pricing Data
| Year |
Average Wholesale Price (AWP) per Patch |
Estimated Monthly Revenue (US) |
| 2020 |
$130 |
$40 million |
| 2022 |
$125 |
$45 million |
Note: AWP values are indicative; actual prices vary by payer contracts and discounts.
Price Projection Outlook
Short-Term (2023-2025)
- Pricing Stability: The average AWP is projected to remain between $120 and $130 per patch, with minor fluctuations reflecting inflation and market negotiations.
- Market Penetration: Increased awareness and expanded insurance coverage could boost prescription volumes by 2-3% annually.
- Reimbursement Trends: Payers might push for lower negotiated prices, potentially reducing net prices by 5-10% over the next two years.
Long-Term (2026 and beyond)
- Emerging Competition: New transdermal contraceptive products with improved formulations could influence price erosion.
- Regulatory Changes: Approval of biosimilars or alternative delivery systems could pressure prices downward.
- Patient Preference Trends: Continued preference for non-oral methods favors product stability but pressure on pricing exists due to increased competition.
Projected Price Range (2026): $115-$125 per patch, assuming competitive market dynamics and no disruptive innovations.
Impact of Market Forces
- Patent exclusivity for Xulane ends in 2024, opening the market for generics.
- Potential entry of generic transdermal contraceptives could reduce prices by 30-50% within a year of launch.
- Insurance coverage expansions, especially through public programs, tend to stabilize prices but may limit premium increases.
Regulatory Environment
- FDA approval for Xulane in 2001.
- Patent expiry scheduled for 2024, enabling generics.
- No recent regulatory hurdles; product remains on the market with ongoing post-marketing surveillance.
Key Takeaways
- The Xulane product (NDC 72603-0121) is a stabilized, mature segment within the contraceptive market with consistent prescription growth.
- Current market price averages around $125 per patch, with a projected slight decrease driven by upcoming patent expiry and competition.
- Revenue from Xulane in the US is approximately $150 million annually.
- Generics entering the market post-2024 could cause significant price erosion.
- Competitive landscape expands with the advent of alternative delivery systems and biosimilars.
FAQs
Q1: When will generic versions of Xulane likely enter the market?
A1: Post-2024, following patent expiration scheduled for that year.
Q2: How will market entry of generics affect prices?
A2: Prices could decrease by 30-50% within a year of generic launch.
Q3: What factors influence current pricing?
A3: Manufacturing costs, payer negotiations, insurance coverage, and market demand.
Q4: Are there recent regulatory changes impacting Xulane?
A4: No significant recent regulatory hurdles; product remains approved and marketed.
Q5: What is the outlook for sales volume?
A5: A 2-3% annual increase is expected due to growing acceptance and insurance coverage expansion.
References
[1] MarketWatch. (2023). "Global Contraceptive Market Size & Trends."
[2] IQVIA. (2022). "Prescription Drug Data: US Market Trends."
[3] FDA. (2022). "Product Approval and Patent Calendar for Xulane."
