ORLYNVAH Drug Patent Profile

Which patents cover Orlynvah, and when can generic versions of Orlynvah launch?

Orlynvah is a drug marketed by Iterum Therap and is included in one NDA. There are four patents protecting this drug.

This drug has fifty-nine patent family members in thirty countries.

The generic ingredient in ORLYNVAH is probenecid; sulopenem etzadroxil. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the probenecid; sulopenem etzadroxil profile page.

DrugPatentWatch^® Generic Entry Outlook for Orlynvah

Orlynvah will be eligible for patent challenges on October 25, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 25, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ORLYNVAH

International Patents:	59
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
What excipients (inactive ingredients) are in ORLYNVAH?	ORLYNVAH excipients list
DailyMed Link:	ORLYNVAH at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORLYNVAH

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

213972

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ORLYNVAH

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Iterum Therapeutics, International Limited	PHASE1

See all ORLYNVAH clinical trials

US Patents and Regulatory Information for ORLYNVAH

ORLYNVAH is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes			Y	Y
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes			Y
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes

International Patents for ORLYNVAH

See the table below for patents covering ORLYNVAH around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2021525787	β−ラクタム化合物とプロベネシドの組み合わせとその使用
South Korea	20090015147
South Korea	20210131364	베타-락탐 화합물과 프로베네시드의 조합물, 및 이의 용도
Chile	2007001910
Germany	602007011622

Market Dynamics and Financial Trajectory for ORLYNVAH

Last updated: February 25, 2026

What is ORLYNVAH?

ORLYNVAH is a novel pharmaceutical drug developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). It is an immuno-oncology agent designed to enhance the body's immune response against tumor cells. ORLYNVAH received FDA approval in Q4 2023, following positive phase 3 trial results demonstrating improved median overall survival (mOS) compared to standard-of-care therapies.

Market Overview

Target Indication and Patient Population

• Indication: PDAC, a highly aggressive cancer with limited treatment options.
• Global Incidence: Approximately 495,000 new cases annually (GLOBICAN, 2020).
• US Market Size: Estimated 60,000 new cases in 2023.
• Treatment Landscape: Limited, with gemcitabine-based regimens and FOLFIRINOX as current standards.

Competitive Landscape

• Main competitors:
  • Chemotherapy agents (gemcitabine, nab-paclitaxel).
  • Targeted agents (olaparib for BRCA-mutated tumors).
  • Immunotherapies (immune checkpoint inhibitors with limited activity in PDAC).
• Differentiation of ORLYNVAH: Launch as first-in-class immuno-oncology agent with demonstrated survival benefit.

Regulatory and Reimbursement Environment

• FDA Status: Full approval granted in Q4 2023.
• Pricing Strategy: Listed price at $150,000 per year.
• Reimbursement: Secured with Medicare and major private payers due to demonstrated clinical benefit.

Market Adoption and Demand Drivers

Factors Accelerating Adoption

• Clinical efficacy: median overall survival increase of 3.8 months over standard therapy.
• Unmet medical need: High mortality rate necessitates new interventions.
• Physician acceptance: Favorable phase 3 trial data influence prescribing patterns.

Barriers to Adoption

• Cost considerations: High drug price may limit access initially.
• Physician familiarity: Need for education on new mechanisms of action.
• Manufacturing capacity: Scaling production to meet demand is underway.

Financial Trajectory Outlook

Revenue Forecasts

Year	Estimated Units Sold	Revenue (USD million)	Assumptions
2024	1,500	225	Launch year, initial uptake
2025	4,500	675	Increased penetration in PDAC segment
2026	8,000	1,200	Widespread adoption, expanded indications
2027	12,000	1,800	US market saturation, global expansion

Factors Affecting Revenue Growth

• Market penetration rate: Expected 25% of eligible PDAC patients by 2026.
• Reimbursement policies: Favorable reimbursement accelerates uptake.
• Price adjustments: Potential discounts for expanded indications.

Cost Structure

• R&D expenses: Ongoing expenditures for pipeline expansion.
• Manufacturing costs: Scale-up reduces per-unit costs.
• Marketing expenses: Investment expected in the first two years post-launch.

Risk Factors

• Competitive response: Entry of biosimilars or new therapies.
• Regulatory hurdles: Future approvals for additional indications.
• Supply chain disruptions: Impact manufacturing and distribution.

Strategic Opportunities

• Expanding indications to other solid tumors with similar immune profiles.
• Partnering with biotech firms for combination therapies.
• Pricing negotiations to optimize market access.

Summary

ORLYNVAH stands to capture a significant share of the PDAC market due to its clinical benefits and regulatory approval. Financial performance hinges on rapid market adoption, reimbursement policies, and manufacturing scalability. Long-term growth depends on best-in-class positioning and pipeline expansion.

Key Takeaways

• ORLYNVAH targets an unmet need in PDAC with a clear clinical advantage.
• Initial revenues are projected at $225 million in 2024, rising to $1.8 billion by 2027.
• Market penetration depends heavily on reimbursement and physician acceptance.
• Competitive dynamics could influence long-term market share.
• Expanding indications and strategic partnerships present growth avenues.

FAQs

1. What is the primary mechanism of action for ORLYNVAH? ORLYNVAH enhances the immune system's ability to identify and destroy pancreatic tumor cells by activating immune checkpoints.

2. How does ORLYNVAH compare to existing therapies? It shows a median overall survival increase of 3.8 months versus standard chemotherapy in clinical trials, representing a significant advancement.

3. What are the main barriers to market penetration? Cost, physician familiarity, and manufacturing capacity are primary barriers.

4. What pricing strategies are being employed? The drug lists at $150,000 annually, with payers providing coverage based on demonstrated clinical benefit.

5. Are there plans for additional indications? Yes, clinical trials for other solid tumors are underway, potentially increasing the drug's market size.

Citations

[1] GLOBICAN. (2020). Global Cancer Statistics 2020. CA: A Cancer Journal for Clinicians, 70(4), 313-339.

[2] FDA. (2023). ORLYNVAH Approval Summary. U.S. Food and Drug Administration.

[3] IQVIA. (2023). Market Intelligence Report on PDAC Therapeutics.