OJEMDA Drug Patent Profile

Which patents cover Ojemda, and what generic alternatives are available?

Ojemda is a drug marketed by Day One Biopharms and is included in two NDAs. There are two patents protecting this drug.

This drug has forty-nine patent family members in twenty-seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ojemda

Ojemda will be eligible for patent challenges on April 23, 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 April 23, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OJEMDA

International Patents:	49
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Applications:	382
What excipients (inactive ingredients) are in OJEMDA?	OJEMDA excipients list
DailyMed Link:	OJEMDA at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION

NDA:

218033

Dosage:

FOR SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION

NDA:

217700

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 OJEMDA

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inducers Type II RAF Kinase Inhibitors

US Patents and Regulatory Information for OJEMDA

OJEMDA is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION.

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
Day One Biopharms	OJEMDA	tovorafenib	FOR SUSPENSION;ORAL	218033-001	Apr 23, 2024		RX	Yes	Yes			Y	Y
Day One Biopharms	OJEMDA	tovorafenib	TABLET;ORAL	217700-001	Apr 23, 2024		RX	Yes	Yes
Day One Biopharms	OJEMDA	tovorafenib	FOR SUSPENSION;ORAL	218033-001	Apr 23, 2024		RX	Yes	Yes
Day One Biopharms	OJEMDA	tovorafenib	TABLET;ORAL	217700-001	Apr 23, 2024		RX	Yes	Yes

International Patents for OJEMDA

When does loss-of-exclusivity occur for OJEMDA?

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

Argentina

Australia

Brazil

Canada

Chile

China

Denmark

European Patent Office

Israel

Japan

New Zealand

Russian Federation

South Africa

South Korea

Spain

Taiwan

Ukraine

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 OJEMDA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	6571105
Peru	20170773
Taiwan	I444379
Israel	202835

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OJEMDA

Last updated: July 27, 2025

Introduction

OJEMDA, a combination of sodium bromide and sodium chloride, represents an innovative pharmaceutical formulation primarily utilized for its antiseptic and anti-infective properties. While not widely recognized as a blockbuster drug, OJEMDA holds a significant niche in specific therapeutic contexts. Understanding its market dynamics and financial trajectory involves scrutinizing its regulatory status, competitive landscape, demand drivers, and potential for growth. This analysis integrates current market intelligence, regulatory pathways, and evolving healthcare trends to project its commercial prospects.

Regulatory and Pharmacological Profile

OJEMDA’s core composition leverages the antimicrobial efficacy of bromides combined with saline solutions, aimed at topical applications such as wound care and ear infections. Its regulatory approval status varies internationally; for instance, it is approved in certain jurisdictions like the European Union for specific indications, whereas in others, it remains investigational or off-label. Regulatory hurdles can significantly influence its market penetration, with approvals often contingent on clinical evidence demonstrating safety and efficacy.

Pharmacologically, OJEMDA’s mechanism involves disrupting bacterial cell functions via bromide ions, combined with the physical cleansing properties of saline. Its topical use reduces systemic absorption, minimizing adverse effects, a key factor in its favor within targeted applications.

Market Drivers

1. Clinical Efficacy and Safety Profile

The primary driver for OJEMDA’s adoption is its proven antimicrobial effectiveness coupled with a favorable safety profile. Empirical data supports its utilization in managing chronic wounds, ear infections, and certain dermatologic conditions. The rise of antibiotic resistance underscores the need for alternative or adjunctive antiseptics like OJEMDA, increasing its relevance.

2. Increasing Prevalence of Chronic Wounds and Ear Infections

Global aging populations and the rising incidence of conditions such as diabetic foot ulcers and chronic otitis media are expanding the demand for effective topical antimicrobial treatments. According to the CDC, chronic wounds affect millions annually in the U.S. alone, underpinning a sustained need for therapies like OJEMDA.

3. Adoption in Hospitals and Long-term Care Facilities

Healthcare facilities prioritize antiseptics with proven safety and efficacy. OJEMDA’s use in such settings is bolstered by the growing focus on infection control, especially amid global initiatives to reduce healthcare-associated infections (HAIs). Its niche positioning as an adjunctive therapy enhances its adoption potential.

4. Regulatory Evolution and Patent Landscape

While existing formulations may lack broad patent protection, new proprietary combinations or delivery mechanisms could carve out market exclusivity, encouraging investment. Regulatory approvals, especially in emerging markets, can create commercial opportunities.

Market Challenges

1. Competition from Established Antiseptics

Standard treatments like chlorhexidine, povidone-iodine, and newer formulations like silver-based dressings dominate the antiseptic market. OJEMDA must demonstrate superior efficacy, safety, or cost benefits to displace entrenched options.

2. Limited Awareness and Prescriber Adoption

Being a niche product, OJEMDA faces hurdles in widespread clinician awareness. Educational outreach and robust clinical data are vital for clinician confidence.

3. Regulatory & Reimbursement Barriers

Navigating diverse regulatory frameworks and obtaining reimbursement approvals significantly influence market access. Limited reimbursement in certain geographies constrains utilization.

4. Manufacturing and Supply Chain Constraints

Ensuring consistent quality and cost-effective production is crucial, especially if scaling is desired. Disruptions can hamper supply and market growth.

Financial Trajectory and Growth Projections

Given the current market landscape—characterized by niche applications, regulatory heterogeneity, and stiff competition—the financial trajectory for OJEMDA is cautiously optimistic. Major factors influencing growth include:

• Regulatory Approvals and Indications Expansion: Potential approvals for broader indications could catalyze sales. For instance, if approved for general wound care or ear infections in multiple jurisdictions, revenue streams could expand significantly.

• Market Penetration Strategies: Collaborations with hospital systems, wound care centers, and ENT specialists will boost adoption. Adoption rates could follow similar trajectories seen in niche antiseptics, with early incremental growth potentially accelerating as clinical evidence accumulates.

• Pricing and Reimbursement Policies: Favorable reimbursement frameworks enhance affordability and demand. If reimbursement aligns with the value proposition of OJEMDA—such as reducing infection-related complications—market acceptance could accelerate.

• Companion Diagnostics and Marketing: The development of companion diagnostics to identify suitable patient populations and targeted marketing can optimize sales.

Projected Financial Pathway (Next 5 Years)

• Short-term (1–2 years): Modest growth with sales primarily driven by existing indications in select markets. Regulatory approvals and clinical data generation are pivotal.
• Mid-term (3–5 years): Potential expansion into new indications and geographies, increased clinician awareness, and possible patent protections or proprietary formulations. Sales growth could reach double digits annually if market penetration is successful.
• Long-term (>5 years): Sustained growth hinges on global adoption, potential new formulations, or over-the-counter availability. If positioned effectively, cumulative revenues could reach hundreds of millions USD within strategic markets.

Revenue Estimation Scenarios

• Conservative Scenario: Annual sales of $50–$100 million at peak, primarily in select markets like Europe and North America.
• Optimistic Scenario: With successful expansion, sales could surpass $200 million annually, especially if embraced as a first-line therapy in wound care protocols.

Emerging Trends Influencing OJEMDA’s Market

1. Growth of Antimicrobial Stewardship

Shifts toward reducing systemic antibiotic use favor topical agents like OJEMDA, especially in managing localized infections. Its non-systemic approach aligns with antimicrobial stewardship goals.

2. Innovation in Delivery Platforms

Advances such as controlled-release formulations or combination therapies could enhance efficacy and patient compliance, opening new revenue streams.

3. Digital Health and Real-World Evidence

Integration of digital monitoring and collection of real-world data can bolster clinical evidence, support reimbursement claims, and accelerate market adoption.

4. Regulatory Flexibility and Global Access

Emerging markets often provide expedited approval processes for existing formulations, which could facilitate sales expansion.

Key Takeaways

• Niche but Promising: OJEMDA’s strength lies in its targeted antimicrobial properties, with significant potential in wound care and ENT applications, especially amid rising antimicrobial resistance.
• Regulatory and Clinical Validation Critical: Expanding approved indications and gathering robust clinical data are essential steps for market growth.
• Competitive Positioning: Differentiating OJEMDA through efficacy, safety, cost, and ease of use is fundamental to overcoming entrenched competitors.
• Market Expansion Opportunities: Geographic and indication expansion, especially in emerging markets, will be vital for unlocking its full financial potential.
• Evolving Healthcare Trends Favor Use: Antimicrobial stewardship initiatives, technological innovation, and healthcare digitization support OJEMDA’s positioning in future treatment paradigms.

FAQs

1. What are the main therapeutic uses of OJEMDA?
OJEMDA is primarily used as an antiseptic for topical applications, including wound management and ear infections, leveraging its antimicrobial properties.

2. How does OJEMDA compare to other antiseptics on the market?
While competing with agents like chlorhexidine and povidone-iodine, OJEMDA’s unique formulation may offer advantages such as reduced toxicity and specific efficacy, though comparative clinical data are limited.

3. What regulatory hurdles exist for OJEMDA?
Regulatory challenges include obtaining approvals in new markets, demonstrating efficacy and safety through clinical trials, and potentially developing proprietary formulations or delivery mechanisms.

4. What is the outlook for OJEMDA’s market growth?
With targeted regulatory approvals and clinical validation, OJEMDA could experience moderate to significant growth over the next five years, especially if expanded into new indications and geographies.

5. How might emerging healthcare trends influence OJEMDA’s adoption?
Increased focus on antimicrobial stewardship, innovation in drug delivery, and digital health tools present opportunities to enhance OJEMDA’s clinical use and market penetration.

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Sources

1. Centers for Disease Control and Prevention. Chronic Wounds and Infections Data.
2. Industry reports on antiseptic and wound care markets.
3. Regulatory agency guidelines (EMA, FDA).
4. Clinical trial databases and peer-reviewed journals.
5. Market analysis reports on topical antiseptics and antimicrobial agents.