Last updated: February 25, 2026
What is NDC 00009-0031?
NDC 00009-0031 corresponds to Cialis (tadalafil) in a 2.5 mg dosage form. Approved by the FDA in 2003, Cialis is used for erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension. The 2.5 mg formulation is primarily prescribed for daily use, often in lower doses to facilitate continuous treatment.
Market Overview
Current Market Position
Cialis holds approximately 20% of the ED drug market share in the U.S., competing with Viagra (sildenafil) and Levitra (vardenafil). As of 2022, annual sales revenue for Cialis approximated $2.2 billion globally, with the U.S. accounting for a substantial portion.
Competitive Landscape
| Product |
Mechanism |
Approval Year |
Major Formulations |
Market Share (2022) |
| Cialis (tadalafil) |
PDE5 inhibitor |
2003 |
2.5 mg (daily), 5 mg, 10 mg, 20 mg |
20% |
| Viagra (sildenafil) |
PDE5 inhibitor |
1998 |
25 mg, 50 mg, 100 mg |
50% |
| Levitra (vardenafil) |
PDE5 inhibitor |
2003 |
5 mg, 10 mg, 20 mg |
15% |
Key Trends
- Expansion of daily low-dose formulations, including 2.5 mg, increases demand for lower-priced, consistent dosing options.
- Patent expirations of sildenafil (2013) and vardenafil (2016) have led to increased generic competition.
- Birth of authorized generics has depressed prices but enhanced accessibility.
- Rising awareness of BPH and multiple indications keeps Cialis relevant beyond ED.
Patent and Regulatory Landscape
Patent Validity
The primary patent protecting Cialis, filed in 1992, expired in 2017 in the U.S. (patent No. 5,387,589). However, several secondary patents and exclusivity rights extend licensing control until at least 2027.
Regulatory Approvals
- 2003: FDA approval for ED
- 2009: FDA approval for BPH
- 2011: FDA approval for pulmonary arterial hypertension
Pricing Dynamics
Current Price Points
| Product |
Typical Retail Price (30 Tablets) |
Wholesale Price (per tablet) |
Average Reimbursement (U.S.) |
| Cialis 2.5 mg |
$120 |
$4 |
$10–$12 |
| Generic tadalafil (per 20 mg) |
$15 |
$0.75 |
$2–$3 |
Price Drivers
- Brand Cialis maintains higher prices due to patent protection and brand loyalty.
- Generic versions drive prices down, often to 15-20% of brand prices.
- Insurance coverage significantly influences out-of-pocket expenses.
Price Projections (Next 3-5 Years)
| Scenario |
Assumptions |
Price Range for 2.5 mg Cialis |
Key Factors Influencing Price |
| Conservative |
Patent exclusivity continues through 2027 |
$10–$15 per tablet |
No major patent challenges or generic entry |
| Moderate |
Generics enter with limited market share |
$5–$10 |
Increased generic supply, insurance coverage expands |
| Aggressive |
Widespread generic competition |
$2–$4 |
Patent challenges successful, high generic penetration |
Analytical Considerations
- Patent expiration in 2027 positions the drug for significant price erosion.
- Continued rise in off-label uses and broad indications could prolong brand importance.
- The adoption of lowest-cost generics will limit brand pricing to remaining niche markets.
Market Drivers and Risks
Drivers
- Aging population increasing ED and BPH prevalence.
- Strong physician and patient acceptance of daily low-dose formulations.
- Growing awareness and diagnosis rates.
Risks
- Accelerated generic market entry reducing brand market share.
- Regulatory or patent challenges undermining exclusivity.
- Shifts in prescribing patterns favoring newer therapies.
Key Takeaways
- NDC 00009-0031 corresponds to a 2.5 mg Cialis tablet, mainly for daily treatment.
- The drug has a significant share of the ED market but faces increasing generic competition.
- Current pricing favors brand with $120 retail for a 30-tablet package; generics can be priced below $20.
- Patent expiry in 2027 will likely decrease prices substantially.
- Market growth hinges on expanding indications and ongoing acceptance of low-dose daily regimens.
FAQs
1. When will Cialis 2.5 mg lose patent protection?
Patent protection is expected to expire in 2027, after which generic manufacturers can enter the market.
2. How does generic competition impact Cialis pricing?
Market entry of generics typically reduces prices for brand-name Cialis by 80-90%, with prices settling around $2–$4 per tablet.
3. What are the primary indications for Cialis 2.5 mg?
It is mainly prescribed for erectile dysfunction with daily low-dose use; also approved for BPH symptoms.
4. How do insurance coverage policies influence retail prices?
Insurance and pharmacy benefit managers often favor generics, leading to lower out-of-pocket costs for patients when generics are available.
5. What are the main factors influencing future price trends?
Patent status, generic market penetration, regulatory actions, and evolving treatment guidelines will shape future pricing.
References
[1] IQVIA. (2022). Pharmacovigilance Data for Erectile Dysfunction Drugs.
[2] FDA. (2021). Cialis (tadalafil) approval and review documentation.
[3] U.S. Patent and Trademark Office. (2017). Patent No. 5,387,589.
[4] Taylor, R., & Smith, L. (2022). Market Trends in Erectile Dysfunction Therapy. Pharmaceutical Economics, 40(5), 253-261.
[5] Medscape. (2022). Erectile Dysfunction Market and Price Trends.
