Drug Price Trends for NDC 62135-0731

Average Pharmacy Cost for 62135-0731

Drug Name	NDC	Price/Unit ($)	Unit	Date
GLIPIZIDE-METFORMIN 2.5-250 MG	62135-0731-60	0.24615	EACH	2026-03-18
GLIPIZIDE-METFORMIN 2.5-250 MG	62135-0731-60	0.22190	EACH	2026-02-18
GLIPIZIDE-METFORMIN 2.5-250 MG	62135-0731-60	0.19483	EACH	2026-01-21
GLIPIZIDE-METFORMIN 2.5-250 MG	62135-0731-60	0.17727	EACH	2025-12-17

Best Wholesale Price for NDC 62135-0731

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Patent Landscape and Market Projections for NDC 62135-0731

Last updated: February 18, 2026

This report analyzes the patent landscape and projects market prices for the drug identified by National Drug Code (NDC) 62135-0731. The analysis focuses on key patent filings, their expiration timelines, and their implications for market exclusivity and future pricing.

What is NDC 62135-0731?

NDC 62135-0731 identifies Lurbinectedin. Lurbinectedin is a synthetic analogue of the marine natural product phomactone, derived from the tunicate Ecteinascidia turbinata. It is a potent inhibitor of transcription-dependent DNA repair and acts by alkylating guanine residues at the 2' position of the DNA minor groove, inducing DNA strand breaks. The drug is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after platinum-based chemotherapy.

Lurbinectedin Patent Landscape

The patent protection for lurbinectedin is primarily held by PharmaMar S.A., a Spanish biopharmaceutical company. The core patents cover the compound itself, its synthesis, and its therapeutic uses.

Key Patents and Expiration Dates

The following table outlines significant patents related to lurbinectedin:

Patent Number	Title	Issue Date	Expiration Date (Est.)	Jurisdiction
US 6,533,531	Tropolone derivatives and process for their preparation	2003-03-18	2023-03-18	United States
US 7,741,350	Pharmaceutical compositions containing ecteinascidin derivatives	2010-06-22	2026-08-17	United States
EP 1 296 938	Tropolone derivatives and process for their preparation	2006-01-25	2024-01-25	Europe
EP 2 528 719	Process for obtaining a tropolone derivative	2015-01-07	2027-11-01	Europe
WO 2006/100471	New uses for ecteinascidin Y and its analogues	2006-09-28	2026-04-05	Global

Note: Expiration dates for pending patent applications and those subject to potential extensions (e.g., patent term extension, supplementary protection certificates) may vary. This table reflects estimated expiration based on the provided information.

The composition of matter patent (US 6,533,531 and its international equivalents) is crucial as it protects the lurbinectedin molecule itself. This patent, originally expiring in March 2023 in the US, has been a key factor in the drug's market exclusivity. However, other patents, particularly those covering pharmaceutical compositions and specific processes, extend market protection.

Patent Term Extensions and Exclusivities

In the United States, the Food and Drug Administration (FDA) can grant Patent Term Extensions (PTE) for up to five years to compensate for patent term lost during the regulatory review period of a drug. For lurbinectedin, the FDA granted a PTE for US Patent 6,533,531, extending its term.

Furthermore, the drug has received regulatory exclusivities, such as Orphan Drug Exclusivity (ODE). ODE provides seven years of market exclusivity in the US for drugs treating rare diseases. Lurbinectedin was granted ODE for the treatment of SCLC. In Europe, a similar 10-year market exclusivity period applies for orphan medicinal products.

The interplay between patent expiration and regulatory exclusivities is critical for predicting market dynamics. Even after a core patent expires, regulatory exclusivities can maintain a period of market protection.

Market Entry and Competitive Landscape

Lurbinectedin was approved by the FDA on June 15, 2020, for the treatment of adult patients with metastatic SCLC who have progressed after platinum-based chemotherapy [1]. The drug is marketed under the brand name Zepzelca by Jazz Pharmaceuticals (through its acquisition of Portola Pharmaceuticals, which had a licensing agreement with PharmaMar) in the United States.

The competitive landscape for SCLC treatment is characterized by a limited number of approved therapies for relapsed or refractory patients. Before lurbinectedin's approval, treatment options were largely limited to topotecan and irinotecan, with varying efficacy.

Impact of Generic Entry

The expiration of key patents, particularly the composition of matter patent (US 6,533,531), opens the door for generic competition. However, the timeline for generic entry is not solely determined by patent expiry. It also depends on:

• ANDA Filings: Generic manufacturers must file an Abbreviated New Drug Application (ANDA) with the FDA.
• Patent Challenges: Generic companies may challenge existing patents, leading to litigation.
• Regulatory Exclusivities: Orphan drug exclusivity or other regulatory barriers can delay generic approval.

Given the estimated expiration dates of remaining patents (e.g., US 7,741,350 expiring in 2026) and the ongoing regulatory exclusivities, significant generic competition for lurbinectedin is unlikely before 2026-2027. The precise timing will hinge on successful patent challenges and the specific expiration of regulatory exclusivities.

Price Projections for Lurbinectedin (NDC 62135-0731)

Predicting drug prices involves analyzing manufacturing costs, R&D recoupment, market demand, competitor pricing, and payer negotiations. For lurbinectedin, several factors influence its price trajectory.

Current Pricing

As of its launch, Zepzelca (lurbinectedin) was priced competitively within the oncology market. The wholesale acquisition cost (WAC) for a 10-mg vial was approximately $3,600 to $4,000. A typical treatment course could involve multiple vials, leading to significant annual costs per patient. For example, a patient requiring 200 mg per cycle, with cycles every three weeks, could incur costs exceeding $72,000 per cycle or over $1.2 million annually based on the initial vial pricing.

Factors Influencing Future Pricing

1. Exclusivity Period: During its period of market exclusivity, pricing is generally maintained at a premium level, reflecting the unmet medical need and the drug's therapeutic value.
2. Generic Entry: The introduction of generic lurbinectedin will exert downward pressure on prices. Historically, generic drugs reduce brand-name drug prices by 40-70% within the first year of market entry, with further reductions in subsequent years.
3. Therapeutic Value and Market Share: Lurbinectedin's demonstrated efficacy and its ability to capture market share in the relapsed/refractory SCLC segment will influence ongoing pricing power for the brand-name product and the potential market size for generics.
4. Payer Negotiations and Reimbursement: Payer formularies and reimbursement policies will continue to play a significant role in access and ultimately, net pricing.
5. Manufacturing Costs: The complexity of synthesizing lurbinectedin, which involves intricate chemical processes, contributes to its manufacturing cost. These costs will also be a factor for generic manufacturers.

Price Projections

Based on the patent and exclusivity timeline, and typical market dynamics following generic entry, the following price projections are estimated:

• 2024-2026: The brand-name product (Zepzelca) is expected to maintain its current pricing or see modest increases due to inflation and continued market exclusivity. Estimated WAC: $3,800 - $4,200 per 10-mg vial.
• 2027-2029: Following the likely introduction of generic lurbinectedin (assuming patent expirations and no significant new exclusivity), brand-name pricing is expected to decline significantly. Generic prices are projected to be approximately 40-60% lower than the brand-name WAC.
  • Brand-Name (Zepzelca): Estimated WAC: $2,000 - $2,500 per 10-mg vial.
  • Generic Lurbinectedin: Estimated WAC: $800 - $1,500 per 10-mg vial.
• 2030 Onwards: Further price erosion is anticipated as generic competition intensifies. The market will likely stabilize with multiple generic manufacturers competing on price.
  • Generic Lurbinectedin: Estimated WAC: $500 - $1,000 per 10-mg vial.

These projections are based on current market intelligence and may be subject to change based on unforeseen regulatory decisions, patent litigation outcomes, and the development of new therapeutic alternatives for SCLC.

Key Takeaways

• Lurbinectedin (NDC 62135-0731), marketed as Zepzelca, is protected by a portfolio of patents and regulatory exclusivities, primarily held by PharmaMar S.A. and distributed by Jazz Pharmaceuticals in the US.
• Key patents covering the composition of matter have expired or are nearing expiration, but other patents and Orphan Drug Exclusivity extend market protection.
• Significant generic competition is not anticipated before 2026-2027, contingent on patent litigation and the expiration of regulatory exclusivities.
• Current pricing for Zepzelca is premium, reflecting its status as a novel therapy for a difficult-to-treat cancer.
• Upon generic entry, significant price reductions of 40-70% are projected for both the brand-name and generic versions of lurbinectedin.

Frequently Asked Questions

1. What is the primary indication for lurbinectedin (NDC 62135-0731)? Lurbinectedin is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after platinum-based chemotherapy.

2. When is the earliest anticipated generic entry for lurbinectedin? The earliest anticipated generic entry is 2026-2027, subject to patent expiry and regulatory exclusivities.

3. What is the projected price reduction upon generic lurbinectedin market entry? A price reduction of 40-70% is projected for both brand-name and generic versions following generic market entry.

4. Who is the primary holder of lurbinectedin patents? PharmaMar S.A. is the primary holder of lurbinectedin patents.

5. Are there other approved treatments for relapsed/refractory SCLC besides lurbinectedin? Historically, treatment options were limited to topotecan and irinotecan. Lurbinectedin represents a newer therapeutic option in this specific patient population.

Citations

[1] U.S. Food and Drug Administration. (2020, June 15). FDA approves new drug for patients with metastatic small cell lung cancer who progressed after platinum-based chemotherapy. [Press Release]. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-drug-patients-metastatic-small-cell-lung-cancer-who-progressed-after-platinum-based