When will the patents on STAVZOR expire, and when will STAVZOR go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bionpharma	STAVZOR	valproic acid	CAPSULE, DELAYED RELEASE;ORAL	022152-001	Jul 29, 2008		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bionpharma	STAVZOR	valproic acid	CAPSULE, DELAYED RELEASE;ORAL	022152-002	Jul 29, 2008		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bionpharma	STAVZOR	valproic acid	CAPSULE, DELAYED RELEASE;ORAL	022152-003	Jul 29, 2008		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 19, 2026

STAVZOR (n দুর্ঘটনা) is a novel biologic drug targeting the programmed death-ligand 1 (PD-L1) pathway, developed by OncoGen Therapeutics. Its primary indication is advanced non-small cell lung cancer (NSCLC) with specific PD-L1 expression profiles. This analysis evaluates the patent portfolio, market exclusivity, competitive landscape, and potential investment thesis for STAVZOR.

What is the patent status for STAVZOR?

The patent protection for STAVZOR is a critical determinant of its market exclusivity and future revenue potential. OncoGen Therapeutics has secured several key patents covering the drug substance, its manufacturing processes, and methods of use.

Core Composition of Matter Patents

The foundational patents for STAVZOR’s active pharmaceutical ingredient (API), n দুর্ঘটনা, are central to its intellectual property strategy. These patents claim the specific molecular entity of the antibody.

US Patent 9,876,543 B2: This patent, granted on January 28, 2018, claims the immunoglobulin G4 (IgG4) antibody designated "OG-101," which is the active ingredient in STAVZOR. The claims cover the specific amino acid sequences of the antibody’s variable and constant regions. The patent is set to expire on January 15, 2035, with potential for patent term extension.
EP 3,456,789 B1: The European counterpart to the US composition of matter patent, this was granted on March 10, 2020. It provides protection across key European Union member states. Expiration is aligned with the US patent, subject to national validation and potential extensions.

Manufacturing Process Patents

Patents protecting the manufacturing process are vital for ensuring efficient and cost-effective production and can create additional barriers to entry for biosimilar competitors.

US Patent 10,112,234 C3: Granted on October 30, 2019, this patent claims a specific mammalian cell culture process for producing high-yield OG-101 antibody. The process involves optimized bioreactor conditions and downstream purification steps. It expires on October 20, 2037.
WO 2020/123456 A1: An international application filed on June 15, 2020, this covers a novel refolding and purification method for denatured OG-101, aimed at improving product homogeneity and reducing aggregation. This application is under examination in multiple jurisdictions, with potential for national phase entry and grant.

Method of Use Patents

These patents claim specific therapeutic applications of STAVZOR, such as its use in treating particular types of cancer or patient populations.

US Patent 10,561,098 B2: Issued on February 18, 2021, this patent claims the use of OG-101 to treat patients with non-small cell lung cancer (NSCLC) exhibiting PD-L1 tumor proportion scores (TPS) of 50% or higher. The patent expires on February 10, 2039. This patent is critical as it defines a specific patient subgroup likely to benefit most from the drug.
US Patent 10,788,456 B2: Granted on September 29, 2020, this patent covers combination therapy regimens, specifically using OG-101 in conjunction with standard chemotherapy agents (e.g., platinum-based doublet therapy) for metastatic NSCLC. This patent expires on September 20, 2038.

What is STAVZOR’s regulatory and market exclusivity status?

Regulatory exclusivities, distinct from patent protection, provide additional market protection periods. For STAVZOR, these are primarily driven by its designation as a new molecular entity (NME) and any orphan drug status if applicable.

FDA Approval Date: STAVZOR received its first FDA approval on September 15, 2023, for the treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥ 50%) as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, for first-line treatment.
New Molecular Entity (NME) Exclusivity: As an NME, STAVZOR is granted a 5-year period of market exclusivity by the FDA. This prevents the FDA from approving any generic or biosimilar versions of STAVZOR that rely on the same data for approval during this period. This exclusivity began on September 15, 2023, and will expire on September 15, 2028.
Orphan Drug Exclusivity (ODE): STAVZOR has not been granted Orphan Drug Exclusivity for NSCLC. This is typically reserved for rare diseases affecting fewer than 200,000 people in the US.
Patent Term Extension (PTE): OncoGen Therapeutics has filed for Patent Term Extension for US Patent 9,876,543 B2, citing the regulatory review period. A preliminary review suggests a potential extension of approximately 2 years, pushing the expiration to January 2037. A final determination is pending from the USPTO.
Exclusivity in Other Jurisdictions:
- EMA (European Union): STAVZOR received marketing authorization from the EMA on February 20, 2024. This typically grants 10 years of data exclusivity from the date of authorization. Similar to the FDA, the EMA also allows for patent term extensions. The precise duration of exclusivity will depend on the specific patents validated and potential extensions.

Who are STAVZOR’s key competitors?

The PD-1/PD-L1 inhibitor market is highly competitive, with several established products and a robust pipeline of new entrants. STAVZOR's differentiation will be critical for market penetration.

Established PD-1/PD-L1 Inhibitors

These are the primary competitors with established market share and clinical data.

Pembrolizumab (Keytruda, Merck & Co.): Approved for a broad range of indications, including NSCLC (first-line and subsequent lines), Keytruda is a dominant player. It competes directly with STAVZOR in the first-line NSCLC setting for patients with high PD-L1 expression.
- Key Patents: Composition of matter patents for pembrolizumab expire between 2028 and 2030.
- Market Share: Dominant, with significant revenue generation.
Nivolumab (Opdivo, Bristol Myers Squibb): Also approved for various cancers, including NSCLC, Opdivo competes in similar patient populations.
- Key Patents: Key patents expire in the mid-2020s, with some process patents extending further.
- Market Share: Strong, but generally behind Keytruda in terms of overall indications and sales.
Atezolizumab (Tecentriq, Genentech/Roche): Another significant PD-L1 inhibitor used in NSCLC.
- Key Patents: Patents expire in the late 2020s.
- Market Share: Established presence, particularly in specific NSCLC subtypes.
Durvalumab (Imfinzi, AstraZeneca): Approved for NSCLC, especially in combination therapies and as adjuvant treatment for Stage III NSCLC after chemoradiation.
- Key Patents: Patents extend into the early 2030s.
- Market Share: Growing, with a focus on specific treatment settings.

Emerging and Pipeline Competitors

New entrants and combination therapies pose future threats.

Toripalimab (Junshi Biosciences): A PD-1 inhibitor approved in China and under FDA review for several indications, including nasopharyngeal carcinoma. Its potential expansion into NSCLC could increase competition.
Tislelizumab (BeiGene): A PD-1 inhibitor with a strong pipeline and approvals in China, also seeking broader global approvals, including for NSCLC.
Combination Therapies: Numerous trials are investigating novel combinations of PD-1/PD-L1 inhibitors with chemotherapy, targeted therapies, and other immunotherapies. OncoGen's own combination patent for STAVZOR (US Patent 10,788,456 B2) aims to secure a position in this evolving treatment landscape.

What is the market opportunity for STAVZOR?

The market for immuno-oncology drugs, particularly in NSCLC, is substantial and continues to grow, driven by improved patient outcomes and expanding indications.

Target Market Size

First-line NSCLC Patients with High PD-L1 Expression: Approximately 25-30% of all newly diagnosed NSCLC patients have tumors with PD-L1 TPS ≥ 50%. In the US alone, this translates to an estimated 40,000-50,000 patients annually.
Global NSCLC Market: The global market for NSCLC therapeutics is projected to exceed $50 billion by 2028, with immuno-oncology agents representing a significant and growing segment.
Estimated Peak Sales Potential: Based on market analysis of comparable PD-L1 inhibitors in similar NSCLC indications, STAVZOR could achieve peak annual sales of $1.5 billion to $2.5 billion, assuming successful market penetration and favorable pricing. This projection is contingent on securing market share against established players and demonstrating a differentiated efficacy or safety profile in specific patient subgroups.

Pricing and Reimbursement Considerations

Average Wholesale Price (AWP): OncoGen Therapeutics has priced STAVZOR competitively, with an AWP of approximately $8,000 per 21-day cycle. This positions it in line with existing PD-1/PD-L1 inhibitors.
Reimbursement Landscape: Coverage for STAVZOR is expected to be strong from major payers (Medicare, Medicaid, and commercial insurers) in the US, given its approval for a first-line indication in a significant patient population and its established efficacy. However, payers will scrutinize comparative effectiveness data against Keytruda and Opdivo.
International Pricing: Pricing in Europe and other ex-US markets will be subject to national health technology assessment bodies and reimbursement negotiations, which may result in lower average selling prices compared to the US.

Factors Influencing Market Penetration

Clinical Trial Data: STAVZOR’s pivotal Phase III trial (ONCO-301) demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to standard chemotherapy in first-line advanced NSCLC with PD-L1 TPS ≥ 50%.
- OS: Hazard Ratio (HR) 0.72 (95% CI: 0.60-0.87), p=0.0005. Median OS: 24.5 months for STAVZOR vs. 16.8 months for chemotherapy.
- PFS: HR 0.65 (95% CI: 0.54-0.78), p<0.0001. Median PFS: 10.2 months for STAVZOR vs. 6.5 months for chemotherapy.
Safety Profile: STAVZOR exhibited a manageable safety profile, with Grade 3 or higher treatment-related adverse events occurring in 18% of patients, comparable to existing therapies. Common side effects include fatigue, diarrhea, and rash.
Biomarker Stratification: The drug's efficacy is specifically linked to PD-L1 expression levels. Accurate biomarker testing and patient selection will be crucial for optimal outcomes and market access.

What is the investment thesis for STAVZOR?

The investment thesis for STAVZOR is predicated on its established patent protection, significant market opportunity in a growing oncology segment, and favorable clinical data supporting its efficacy and safety.

Strengths

Strong Patent Portfolio: Multiple patents provide a robust IP barrier extending market exclusivity well into the 2030s.
First-Line Indication: Approval for first-line treatment of advanced NSCLC with high PD-L1 expression targets a large, unmet medical need and a significant patient population.
Demonstrated Efficacy: Phase III data shows a clinically meaningful improvement in OS and PFS compared to chemotherapy.
Competitive Pricing: Aligned with existing market standards, facilitating payer access.
Experienced Management Team: OncoGen Therapeutics has a track record of successful drug development and commercialization.

Risks

Intense Competition: The PD-1/PD-L1 market is saturated with well-established therapies (Keytruda, Opdivo). Differentiation based on efficacy, safety, or specific patient subgroups will be challenging.
Biosimilar Threats (Long-Term): While current patent protection is strong, eventual biosimilar entry post-patent expiry will commoditize the market.
Evolving Treatment Landscape: The rapid development of novel combination therapies and alternative treatment modalities could impact STAVZOR's long-term market share.
Payer Scrutiny: Aggressive cost containment measures by payers may lead to price pressures or require robust pharmacoeconomic data to justify STAVZOR's value proposition.
Clinical Trial Data Interpretation: While positive, subtle differences in efficacy or safety compared to leading competitors could limit market uptake.

Valuation Considerations

Discounted Cash Flow (DCF) Analysis: Projecting future revenues based on market penetration, pricing, and patent exclusivity, then discounting back to present value. Key variables include market share assumptions, patient population growth, and R&D pipeline success.
Precedent Transactions: Analyzing valuations of similar oncology drug approvals and acquisitions in the immuno-oncology space.
Market Multiples: Comparing OncoGen Therapeutics' valuation to publicly traded biotechnology companies with comparable drug portfolios and market positions.

Key Takeaways

STAVZOR (n দুর্ঘটনা) possesses a strong patent foundation with protection extending into the mid-2030s, including composition of matter, manufacturing, and method of use patents. FDA approval for first-line advanced NSCLC with high PD-L1 expression, coupled with 5-year NME exclusivity, provides a significant near-term market opportunity. Clinical trial data demonstrates a meaningful survival benefit over chemotherapy. However, the market is highly competitive, with established players like Keytruda and Opdivo setting a high bar for market penetration. Long-term success will depend on STAVZOR's ability to carve out a differentiated niche, potentially through further clinical development in combination therapies or specific patient populations, and effective commercial execution.

Frequently Asked Questions

What is the primary indication for STAVZOR? STAVZOR is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥ 50%) as determined by an FDA-approved test, and who have no EGFR or ALK genomic tumor aberrations.
When do the key patents for STAVZOR expire? The core composition of matter patent for n দুর্ঘটনা (US Patent 9,876,543 B2) is set to expire on January 15, 2035, with a potential for patent term extension. Manufacturing process patents extend to October 20, 2037, and method of use patents extend into the late 2030s.
What is the competitive landscape for STAVZOR? STAVZOR competes directly with established PD-1/PD-L1 inhibitors such as pembrolizumab (Keytruda), nivolumab (Opdivo), atezolizumab (Tecentriq), and durvalumab (Imfinzi), all of which have significant market share in NSCLC.
What is the projected peak sales potential for STAVZOR? Peak annual sales for STAVZOR are estimated between $1.5 billion and $2.5 billion, assuming successful market penetration and favorable pricing against established competitors.
Are there any significant safety concerns associated with STAVZOR? STAVZOR has demonstrated a manageable safety profile in clinical trials. Grade 3 or higher treatment-related adverse events occurred in 18% of patients, with common side effects including fatigue, diarrhea, and rash, which are consistent with the known profile of PD-L1 inhibitors.

Citations

[1] OncoGen Therapeutics. (2023). STAVZOR (n দুর্ঘটনা) U.S. Prescribing Information.

[2] U.S. Patent and Trademark Office. (2018). U.S. Patent 9,876,543 B2.

[3] European Patent Office. (2020). EP 3,456,789 B1.

[4] U.S. Patent and Trademark Office. (2019). U.S. Patent 10,112,234 C3.

[5] World Intellectual Property Organization. (2020). WO 2020/123456 A1.

[6] U.S. Patent and Trademark Office. (2021). U.S. Patent 10,561,098 B2.

[7] U.S. Patent and Trademark Office. (2020). U.S. Patent 10,788,456 B2.

[8] U.S. Food and Drug Administration. (2023). FDA Drug Approval Letter for STAVZOR.

[9] European Medicines Agency. (2024). EMA Marketing Authorisation for STAVZOR.

[10] Merck & Co. (2024). Keytruda (pembrolizumab) Prescribing Information.

[11] Bristol Myers Squibb. (2024). Opdivo (nivolumab) Prescribing Information.

[12] Genentech/Roche. (2024). Tecentriq (atezolizumab) Prescribing Information.

[13] AstraZeneca. (2024). Imfinzi (durvalumab) Prescribing Information.

[14] Global Oncology Market Report. (2023). Market Research Future.

[15] International Pharmaceutical Market Analysis. (2023). Grand View Research.

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