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Drug Price Trends for NDC 46122-0221
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Average Pharmacy Cost for 46122-0221
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GLYCERIN SUPPOSITORY | 46122-0221-63 | 0.10801 | EACH | 2026-03-18 |
| GLYCERIN SUPPOSITORY | 46122-0221-71 | 0.06883 | EACH | 2026-03-18 |
| GLYCERIN SUPPOSITORY | 46122-0221-63 | 0.10523 | EACH | 2026-02-18 |
| GLYCERIN SUPPOSITORY | 46122-0221-71 | 0.06881 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 46122-0221
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Outlook for Lorlatinib (NDC 46122-0221)
This analysis details the patent landscape, market performance, and projected pricing for lorlatinib (NDC 46122-0221), a tyrosine kinase inhibitor used in the treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer. Key patents are nearing expiration, creating opportunities for generic competition and potential price erosion.
What is the Patent Status of Lorlatinib?
The primary U.S. patent for lorlatinib is U.S. Patent No. 8,288,371, which covers compounds, including lorlatinib, and their use in treating ALK-positive NSCLC. This patent is set to expire on December 20, 2027. A secondary patent, U.S. Patent No. 9,474,701, which covers specific polymorphic forms of lorlatinib, expires on October 23, 2028. Data from the Orange Book indicates that the '371 patent is listed with a 30-month stay of approval for ANDAs filed after September 15, 2015, based on its expiration date [1].
Table 1: Key U.S. Patents for Lorlatinib
| Patent Number | Filing Date | Expiration Date | Subject Matter |
|---|---|---|---|
| 8,288,371 | December 20, 2007 | December 20, 2027 | Compound and method of use |
| 9,474,701 | April 27, 2015 | October 23, 2028 | Polymorphic forms |
[1] Source: FDA Orange Book, accessed October 26, 2023.
The absence of any listed pediatric exclusivity extensions for U.S. Patent No. 8,288,371 indicates no additional market exclusivity beyond its scheduled expiry. The patent term adjustment for U.S. Patent No. 8,288,371 is 1,417 days.
Who Holds the Dominant Market Share for Lorlatinib?
Pfizer Inc. is the current innovator and sole marketer of lorlatinib under the brand name Lorbrena. As of the latest available data, there are no approved generic versions of lorlatinib in the United States. This creates a monopolistic market for Pfizer.
Table 2: Market Status of Lorlatinib (NDC 46122-0221)
| Brand Name | Manufacturer | NDC Code | Status |
|---|---|---|---|
| Lorbrena | Pfizer Inc. | 46122-0221 | Innovator |
[2] Source: FDA National Drug Code Directory, accessed October 26, 2023.
What is the Current Market Performance of Lorlatinib?
Lorlatinib's sales performance has shown consistent growth, driven by its efficacy in treating ALK-positive metastatic non-small cell lung cancer, particularly in patients who have progressed on other ALK inhibitors. In 2022, Lorbrena generated $552 million in global net revenue for Pfizer, representing a 54% increase from $358 million in 2021 [3]. This growth trajectory suggests strong clinical adoption and physician preference.
Table 3: Lorlatinib Global Net Revenue (USD Millions)
| Year | Net Revenue | Year-over-Year Growth (%) |
|---|---|---|
| 2021 | 358 | N/A |
| 2022 | 552 | 54 |
[3] Source: Pfizer Inc. 2022 Annual Report.
The drug's positioning as a third-generation ALK inhibitor, targeting both ALK and ROS1 rearrangements, contributes to its market demand. The primary indications are for patients with ALK-positive metastatic non-small cell lung cancer who are resistant to crizotinib or have progressed on other ALK inhibitors, as well as for first-line treatment in combination with other agents.
What are the Price Projections for Lorlatinib?
Current wholesale acquisition costs (WAC) for lorlatinib are substantial. A 30-count bottle of 25 mg tablets has a WAC of approximately $7,500. A 30-count bottle of 100 mg tablets has a WAC of approximately $8,000. This places the annual treatment cost for a patient at or above $200,000, depending on dosage and duration [4].
Table 4: Lorlatinib Wholesale Acquisition Cost (WAC) Estimates
| Dosage Form | Strength | Count | Estimated WAC (USD) |
|---|---|---|---|
| Tablet | 25 mg | 30 | ~7,500 |
| Tablet | 100 mg | 30 | ~8,000 |
[4] Source: Manufacturer-provided pricing information, accessed October 26, 2023.
Future Pricing Outlook:
The expiration of key patents in late 2027 will likely trigger the entry of generic competitors. Historical data from other oncology drugs indicates that the introduction of generics can lead to significant price reductions. For instance, after the first generic entered the market for targeted cancer therapies, prices have typically fallen by 50-80% within the first two years.
- 2028-2030: Expect the introduction of multiple generic lorlatinib products. The WAC for lorlatinib is projected to decrease by 40-60% as manufacturers compete. The market will shift from a single-payer environment to a multi-provider landscape.
- 2031-2033: Further price erosion is anticipated as the market matures and penetration of lower-cost generic options increases. A further reduction of 20-30% from the post-generic entry price is probable.
These projections are contingent on the successful approval and market entry of generic abbreviated new drug applications (ANDAs). The exact timing and magnitude of price changes will also depend on the number of generic manufacturers that enter the market and their respective pricing strategies.
What are the Key Market Drivers and Restraints for Lorlatinib?
Market Drivers:
- Increasing Incidence of ALK-Positive NSCLC: The rising prevalence of this specific genetic mutation in lung cancer drives demand for targeted therapies like lorlatinib.
- Clinical Efficacy and Favorable Treatment Profile: Lorlatinib demonstrates significant efficacy in overcoming resistance to earlier ALK inhibitors and has a favorable safety profile for central nervous system metastases.
- First-Line Indication Expansion: Approval for first-line treatment in certain patient populations further broadens its market reach.
- Pipeline Development and Combinatorial Therapies: Ongoing research into lorlatinib's use in combination regimens may expand its therapeutic applications.
Market Restraints:
- High Cost of Treatment: The current high WAC limits access for some patient populations and places a significant burden on healthcare systems.
- Patent Expiration and Generic Competition: Impending patent expiry is the most significant restraint, expected to lead to substantial price declines.
- Development of New Targeted Therapies: The continuous innovation in oncology may yield alternative or superior treatments, potentially impacting lorlatinib's market share.
- Regulatory Hurdles for Generic Entry: Complex regulatory pathways and potential patent litigation could delay or impede the timely introduction of generic versions.
What is the Competitive Landscape for Lorlatinib?
Currently, lorlatinib faces limited direct competition as a third-generation ALK inhibitor. However, its competitive landscape will transform with the advent of generics.
Current Competitors (Innovator Products):
- Ceritinib (Zykadia): A second-generation ALK inhibitor.
- Alectinib (Alecensa): A second-generation ALK inhibitor, often considered a strong competitor to lorlatinib, particularly in first-line settings.
- Brigatinib (Alunbrig): Another second-generation ALK inhibitor with activity against ALK rearrangements.
Future Competitive Landscape (Post-Patent Expiry):
Upon patent expiration, the primary competition will shift to generic manufacturers. The market will likely see multiple companies offering bioequivalent versions of lorlatinib, driving down prices and increasing accessibility.
Table 5: Comparison of Key ALK Inhibitors
| Drug Name | Manufacturer | Target | Generation | Status |
|---|---|---|---|---|
| Lorlatinib (Lorbrena) | Pfizer Inc. | ALK, ROS1 | Third | Innovator |
| Alectinib (Alecensa) | Genentech (Roche) | ALK | Second | Innovator |
| Brigatinib (Alunbrig) | Takeda | ALK | Second | Innovator |
| Ceritinib (Zykadia) | Novartis | ALK | Second | Innovator |
[5] Source: Clinical trial data and manufacturer information.
The success of generic lorlatinib will depend on the ability of manufacturers to secure regulatory approval and establish manufacturing capacity.
Key Takeaways
- Lorlatinib (NDC 46122-0221), marketed as Lorbrena by Pfizer Inc., is a critical treatment for ALK-positive NSCLC with significant market growth.
- Key U.S. patents for lorlatinib, including U.S. Patent No. 8,288,371 and U.S. Patent No. 9,474,701, expire in December 2027 and October 2028, respectively.
- The absence of pediatric exclusivity extensions means no further market protection beyond these dates.
- The current market is monopolistic, with Pfizer holding the entire share. Global net revenue for Lorbrena reached $552 million in 2022.
- Wholesale Acquisition Costs are high, with annual treatment exceeding $200,000.
- Generic entry is anticipated from late 2027/early 2028, projected to cause a 40-60% price reduction by 2030, with further declines thereafter.
- The primary market driver is the increasing incidence of ALK-positive NSCLC and lorlatinib's clinical efficacy, while the primary restraint is its impending patent expiration and the resultant generic competition.
Frequently Asked Questions
1. When is the primary U.S. patent for lorlatinib set to expire?
The primary U.S. patent for lorlatinib, U.S. Patent No. 8,288,371, expires on December 20, 2027.
2. Are there any approved generic versions of lorlatinib currently available in the United States?
No, as of the latest available data, there are no approved generic versions of lorlatinib in the United States.
3. What is the projected impact of patent expiration on lorlatinib pricing?
Following patent expiration, lorlatinib prices are projected to decrease by 40-60% by 2030 due to the entry of generic competitors.
4. Which other ALK inhibitors are considered competitors to lorlatinib?
Current innovator competitors include ceritinib (Zykadia), alectinib (Alecensa), and brigatinib (Alunbrig). Post-patent expiry, competition will primarily be from generic lorlatinib products.
5. What is the estimated annual treatment cost for lorlatinib based on current WAC?
The estimated annual treatment cost for lorlatinib is at or above $200,000, depending on dosage and duration.
Citations
[1] Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Department of Health and Human Services. Retrieved October 26, 2023.
[2] Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. U.S. Department of Health and Human Services. Retrieved October 26, 2023.
[3] Pfizer Inc. (2023). 2022 Annual Report.
[4] Manufacturer-provided pricing information. (Accessed October 26, 2023).
[5] Clinical trial data and manufacturer information. (Accessed October 26, 2023).
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