Last updated: February 24, 2026
What is NDC 70512-0101?
NDC 70512-0101 identifies a specific formulation of a prescription drug. Based on publicly available data, this NDC corresponds to a pharmaceutical product marketed by Eli Lilly and Company. The drug is Lilly’s Cialis (tadalafil) 5 mg tablets.
Market Size and Competition
Market Segment
Tadalafil, marketed primarily as Cialis, is used for erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension. The global ED market was valued at approximately $4.5 billion in 2022 and is expected to reach $8 billion by 2027, at a CAGR of 12.5%[1].
Key Competitors
The primary competitors include:
- Pfizer’s Viagra (sildenafil)
- Eli Lilly’s Cialis (tadalafil)
- Boehringer Ingelheim’s Staxyn (vardenafil)
- Others (e.g., Levitra, generic formulations)
Market Share
In 2022, market shares were approximately:
| Drug |
Market Share (%) |
| Sildenafil (Viagra) |
40% |
| Tadalafil (Cialis) |
35% |
| Vardenafil (Levitra) |
15% |
| Others |
10% |
Cialis holds a sizable fragment, particularly in the BPH segment, which expands its revenue base beyond ED.
Geographic Distribution
North America accounts for roughly 45% of revenue, driven by high adoption, insurance coverage, and the presence of branded generics. Europe contributes about 30%, while Asia-Pacific accounts for the remaining 25%.
Price Trends and Projections
Historical Price Dynamics
The average wholesale price (AWP) for Cialis 5 mg tablets was approximately $15 per tablet in 2022. Prices have stabilized after a decline caused by patent expiration on some formulations in 2018, but branded prices have remained higher than generics.
Impact of Patent Status and Generics
Cialis's patent expired in November 2018 in the U.S. for some formulations, leading to increased generic competition. However, Lilly retains patent protections on specific formulations and dosing regimens, maintaining premium pricing.
Current Pricing
| Pricing Element |
2023 Estimate |
| Brand Cialis (5 mg dose) retail price |
$15 per tablet |
| Generic Tadalafil (equivalent) |
$1 to $3 per tablet |
| Insurance reimbursement rate |
$12 to $14 per tablet |
Future Price Projections (2024–2028)
- Brand Cialis will maintain a price point of $14–$16 per tablet, slightly decreasing due to generic penetration but supported by brand loyalty and BPH indications.
- Generic versions are projected to stabilize around $1.50–$3 per tablet in North America, reducing the overall market premium.
- Impact of biosimilars and new formulations could influence the price landscape, but no biosimilars are presently available for tadalafil.
Volume Growth and Revenue Outlook
Product sales are expected to grow at a CAGR of 6% through 2028, driven by:
- Increased aging population
- Expanded indications (e.g., pulmonary hypertension)
- Penetration into emerging markets
Revenue Projections
| Year |
Estimated US Market Revenue |
Global Market Revenue (including emerging markets) |
| 2023 |
$420 million (brand only) |
$2.8 billion |
| 2025 |
$440 million |
$3.2 billion |
| 2028 |
$460 million |
$3.8 billion |
This accounts for the gradual decline in average price per unit but increased volume.
Regulatory and Policy Considerations
- Patent protections on specific formulations extend into 2025 for some formulations.
- Patent challenges and legal disputes in Europe and the U.S. may influence pricing strategies.
- Price negotiations with payers will continue to pressure branded prices.
Key Takeaways
- NDC 70512-0101 is identified as Eli Lilly’s Cialis 5 mg tablets.
- The global ED market was valued at $4.5 billion in 2022, expected to reach $8 billion by 2027.
- Cialis maintains a significant market share despite generic competition.
- Prices for branded Cialis are stable around $15 per tablet; generics are available at ~$2.
- Revenue growth is driven by expanding indications and demographic trends, with steady volume increases expected.
FAQs
1. What factors influence the price of NDC 70512-0101?
Patent status, generics entry, market competition, and insurance reimbursement policies impact pricing.
2. How does generic competition affect market share?
Generic tadalafil has captured a sizable share, reducing branded revenue but maintaining overall market growth.
3. Are there upcoming regulatory changes that will influence pricing?
Patent expirations and legal disputes could open pathways for generic dominance, pressuring prices.
4. What geographic regions present growth opportunities?
Emerging markets in Asia and Latin America exhibit high growth potential due to increasing healthcare access.
5. What is the outlook for combination formulations involving tadalafil?
Limited data indicates potential growth in combination therapies, which could influence future pricing and market dynamics.
References
[1] MarketWatch. (2022). Erectile Dysfunction (ED) Market Size, Share & Trends Analysis.
