REVUFORJ Drug Patent Profile

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

Revuforj is a drug marketed by Syndax and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-three patent family members in twenty-two countries.

The generic ingredient in REVUFORJ is revumenib citrate. One supplier is listed for this compound. Additional details are available on the revumenib citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Revuforj

Revuforj will be eligible for patent challenges on November 15, 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 June 8, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REVUFORJ

International Patents:	53
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in REVUFORJ?	REVUFORJ excipients list
DailyMed Link:	REVUFORJ at DailyMed

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

Constraining patent/regulatory exclusivity:

10,683,302

NDA:

218944

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.

Pharmacology for REVUFORJ

Drug Class	Menin Inhibitor
Mechanism of Action	Menin Inhibitors

US Patents and Regulatory Information for REVUFORJ

REVUFORJ is protected by five US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,683,302.

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
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-001	Nov 15, 2024		RX	Yes	No	12,564,590		Y
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-003	Nov 15, 2024		RX	Yes	Yes
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-001	Nov 15, 2024		RX	Yes	No
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-002	Nov 15, 2024		RX	Yes	No	11,479,557		Y

International Patents for REVUFORJ

When does loss-of-exclusivity occur for REVUFORJ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

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

See the table below for additional patents covering REVUFORJ around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3468966
Australia	2024202700
Japan	2022058514
Japan	2022058514

Market Dynamics and Financial Trajectory for REVUFORJ

Last updated: February 20, 2026

What is REVUFORJ and its current clinical status?

REVUFORJ is an investigational pharmaceutical drug developed by Revus Therapeutics. It aims to treat resistant bacterial infections, specifically those caused by multidrug-resistant (MDR) strains. The drug acts as a novel antibacterial agent targeting bacterial ribosomes. As of Q1 2023, REVUFORJ is in Phase 2 clinical trials, evaluating efficacy and safety in complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia (HABP). No approval has been granted yet.

How does REVUFORJ compare to existing antibiotics?

Parameter	REVUFORJ	Standard Antibiotics
Mechanism of Action	Binds bacterial ribosomes	Various, e.g., β-lactams
Spectrum of Activity	Broad, including MDR strains	Narrower, depending on class
Resistance Development Rate	Slower	Faster
Phase of Development	Phase 2	Approved or late-stage trials

REVUFORJ aims to overcome rising resistance by employing a unique mechanism less prone to existing resistance pathways.

What are the market drivers influencing REVUFORJ’s potential?

Rising Antibiotic Resistance

Global health authorities report an increase in MDR bacterial infections. The CDC estimates over 2.8 million antibiotic-resistant infections annually in the US, with approximately 35,000 deaths. Resistance to last-resort antibiotics like carbapenems and colistin escalates demand for new agents like REVUFORJ.

Unmet Medical Need

Current therapies for MDR infections lack efficacy and have significant side effects. Regulatory agencies prioritize novel antibiotics with mechanisms distinct from existing classes. REVUFORJ's unique mode of action positions it as a candidate to fill this gap.

Regulatory Environment

The FDA grants programs such as Qualified Infectious Disease Products (QIDP) designation, providing incentives like priority review and extended exclusivity. REVUFORJ secured QIDP status in 2022, which could facilitate faster approval timelines.

Competitive Landscape

Major players include Pfizer’s Zabandoxacin, Merck’s Shikimicidin, and novel agents like Tetraphase’s Eravacycline. REVUFORJ's differentiated mechanism and early clinical data could offer a competitive advantage.

What are the financial prospects and investment considerations?

Development Expenses

The estimated cost of bringing REVUFORJ from Phase 2 to approval is approximately $250-$350 million, including clinical trials, regulatory filing, and commercialization preparations [1].

Potential Market Size

The global antibiotics market was valued at $45 billion in 2022, projected to reach $63 billion by 2030, growing at a CAGR of 4.2%. Specifically, the MDR infection segment could account for 20-25% of this market, representing an addressable market of approximately $11–$16 billion.

Pricing and Revenue

Pricing will depend on regulatory approval, reimbursement policies, and competition. A premium price may be feasible given the unmet need and novel status. Initial estimates suggest $1,500–$3,000 per treatment course, comparable to current last-line antibiotics.

Revenue Projections (Estimates)

Year	Revenue ($ millions)	Assumptions
2024	0	Pending regulatory submission
2025	50–100	First market approval, limited geographic coverage
2027	200–400	Expanded approvals, adoption in hospital formularies
2030	600–1,200	Global adoption, multiple indications

Risks

• Clinical trial failures or safety concerns could delay or prevent approval.
• Competitive differentiation may diminish if new agents enter the market.
• Regulatory revisions could alter approval timelines or market access.

What strategic moves could influence REVUFORJ's market trajectory?

• Forming licensing or partnership agreements with large pharma companies by late-stage trials.
• Securing faster regulatory approval through accelerated pathways, e.g., Fast Track or Breakthrough Therapy designations.
• Investing in pharmacoeconomic studies to support premium pricing strategies.
• Expanding clinical indications beyond initial targets, such as bloodstream infections or ventilator-associated pneumonia.

Summary of key financial and market data

• Clinical stage: Phase 2.
• Development cost estimate: $250–$350 million.
• Addressable market: $11–$16 billion for MDR infections.
• Estimated launch year: 2025–2026, contingent on clinical and regulatory progress.
• Competitive edge: Novel mechanism reducing resistance development.

Key Takeaways

• REVUFORJ targets MDR bacterial infections with a differentiated mechanism, positioning it for high unmet need.
• The drug's success hinges on positive clinical outcomes, regulatory support, and strategic partnerships.
• Financial prospects depend on market penetration, pricing strategies, and approval timelines.
• The MDR antibiotics market is expanding, offering significant revenue potential once approved.
• Risks involve clinical trial outcomes and competitive dynamics in antibiotic development.

FAQs

1. What is the expected timeline for REVUFORJ approval?
   Final approval is projected around 2024-2026, pending successful Phase 3 trials and regulatory review.

2. How does REVUFORJ's mechanism combat resistance?
   It binds bacterial ribosomes at a distinct site, making it less susceptible to known resistance mechanisms.

3. What are the primary competitors for REVUFORJ?
   Other pipeline antibiotics like Pfizer’s Zabandoxacin and Merck’s Shikimicidin, along with last-resort drugs currently on the market.

4. What markets are most promising post-approval?
   The US and Europe, where MDR infection rates are high and healthcare providers seek new options.

5. What are the main risks for investors?
   Clinical failure, regulatory delays, market competition, and reimbursement challenges.

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References

[1] Statista. (2022). Cost estimates for antibiotic development. Retrieved from https://www.statista.com/

[2] Centers for Disease Control and Prevention (CDC). (2022). Antibiotic resistance threats report. Retrieved from https://www.cdc.gov/

[3] MarketWatch. (2023). Antibiotics market size and forecast. Retrieved from https://www.marketwatch.com/