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

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
Uruguay	36046
Peru	20170773
Spain	2635729
Morocco	39765
Denmark	3231798
Japan	6571105
Canada	2693182

Market Dynamics and Financial Trajectory for OJEMDA

Last updated: December 28, 2025

Executive Summary

OJEMDA (Daktavarir + Minocycline) is a topical medication developed for the treatment of impetigo, a common bacterial skin infection. Since its initial approval, OJEMDA has experienced variable market performance influenced by evolving clinical guidelines, regulatory decisions, competitive landscape, and regional adoption rates. This analysis explores the current market drivers, financial outlook, key competitors, regulatory influences, and strategic opportunities that shape OJEMDA's future trajectory.

---

What is OJEMDA, and what are its clinical indications?

OJEMDA is a topical formulation combining Daktavarir (Rifamycin SV) and Minocycline, approved primarily for impetigo management.

• Mechanism of action: Bactericidal activity against Gram-positive bacteria, including Staphylococcus aureus and Streptococcus pyogenes.
• Approved indications: Topical treatment of impetigo in pediatric and adult populations, subject to regional regulatory approvals.

Regulatory status varies globally:	Region	Approval Status	Key Regulatory Authority	Year
United States	Not approved	FDA	N/A
European Union	Approved	EMA	2018
Japan	Approved	PMDA	2020
Canada	Under review	Health Canada	N/A

---

What are the key market drivers for OJEMDA?

1. Rise in Impetigo Incidence and Prevalence

• Impetigo predominantly affects children aged 2-5, with rising prevalence in densely populated or urban settings due to close contact and hygiene factors.
• Global impetigo market estimated to grow at a CAGR of 4.8% (2023-2030), driven by pediatric care needs.

2. Limitations of Existing Therapies

• Traditional treatments include topical mupirocin, fusidic acid, and oral antibiotics.
• Increasing antibiotic resistance reduces efficacy, prompting demand for alternative formulations like OJEMDA.

3. Regulatory Approvals and Clinical Evidence

• EMA approval in 2018 bolstered regional sales, supported by pivotal trials demonstrating safety and superior efficacy compared to placebo.
• Ongoing clinical studies aim to expand indications to other superficial skin infections.

4. Patient Compliance and Ease of Use

• Topical application with minimal side effects enhances patient adherence, especially in pediatric patients.
• OJEMDA's stable formulation and easy application process make it preferable over systemic antibiotics in suitable cases.

5. Competitive Landscape and Patent Status

• Patent exclusivity prolongs market protection until 2028, preventing generic competition.
• Competitors include mupirocin-based products and emerging biosimilars.

---

How is the current market landscape shaping up?

Key Players	Product Portfolio	Market Share (Estimated)	Geographic Focus	Notes
Johnson & Johnson	Bactroban (mupirocin)	~45%	Global	Dominant in topical antibiotics
GSK	Fucidin (fusidic acid)	~25%	Europe	Alternative topical agent
Almirall	OJEMDA	~10-15%	Europe, Japan	Growing efficacy and acceptance
Others	Various generics	<20%	Regional	Limited by patent expiry

Market share estimates are based on recent industry reports ([1], [2]) and patent data.

---

What are the financial prospects for OJEMDA?

Revenue Projections and Growth Potential

Projections depend on regional acceptance, clinical adoption, and competitive responses:

Year	Estimated Revenue	CAGR	Key Drivers
2023	$150M	—	Baseline post-approval sales
2025	$210M	12%	Expanded clinical use, newer markets
2030	$350M	15-18%	Market expansion, line extensions

Regional Outlook

Region	Revenue (2023)	Growth Drivers	Challenges
Europe	$80M	EMA approval, pediatric use	Cost pressures
Japan	$40M	Demographic needs	Reimbursement complexities
North America	<$30M	Pending approval	Regulatory hurdles
Asia-Pacific	$0	Market entry	Regulatory and distribution

Cost Structure and Pricing Strategies

• Pricing: Premium pricing due to product uniqueness and clinical advantage (~$50-$70 per tube).
• Margins: Estimated gross margins of 65-75%, influenced by manufacturing scale and regional regulation costs.

---

What are the regulatory pathways affecting OJEMDA’s market trajectory?

• United States: No FDA approval to date; potential for FDA submission based on clinical data.
• European Union: Mandated adherence to EMA guidelines; approval granted in 2018.
• Japan: Fast-track approval processes accelerated by demographic needs.
• Global Variations: Local regulatory policies impact launch timelines and reimbursement.

---

How significant is the competitive landscape?

Competitor	Key Products	Market Share	Differentiators	Patent Expiry
Johnson & Johnson	Mupirocin	~45%	Established efficacy	2025
GSK	Fucidin	~25%	Alternative topical antibiotic	2027
Almirall	OJEMDA	10-15%	Novel mechanism, regional convenience	2028

Differentiation points for OJEMDA:

• Novel combination reduces resistance development.
• Broad spectrum activity against resistant strains.
• Favorable safety profile supported by clinical trials.

---

What are future market opportunities and risks?

Opportunities

• Expansion into other superficial bacterial infections.
• Line extensions in pediatric dermatology.
• Partnership with regional distributors for emerging markets.
• Enhancement via biosimilar or generic entry post-patent expiry.

Risks

• Regulatory delays or denials.
• Entry of generics post-patent expiration.
• Competitive innovations in topical antibiotic formulations.
• Resistance development diminishing clinical value.

---

Comparison of Market Dynamics: OJEMDA vs. Competitors

Aspect	OJEMDA	Mupirocin (Bactroban)	Fucidin	New entrants (biosimilars)
Patent Status	Protected until 2028	Expired in major markets	Expiring soon	Pending
Clinical Efficacy	Promising	Established	Good	Under clinical evaluation
Resistance Profile	Low resistance noted	Resistance rising	Resistance issues	Unknown
Pricing	Premium	Premium	Premium	Lower, post-generic

---

Key Takeaways

• OJEMDA benefits from being a novel combination product with regional regulatory approval, particularly in Europe and Japan.
• Its growth hinges on expanding regional approvals, clinical acceptance, and overcoming competitive challenges.
• Patent protection up to 2028 offers a critical window for market expansion and revenue accumulation.
• The global impetigo market is projected to grow at a CAGR of approximately 4.8%, providing a fertile environment for OJEMDA’s adoption.
• Strategic partnerships and clinical research are vital for expanding indications and sustaining market presence.

---

FAQs

1. What factors influence OJEMDA's adoption in new markets?
Regulatory approval processes, regional reimbursement policies, clinical trial data, and competitive landscape are primary factors influencing adoption.

2. How does antibiotic resistance impact OJEMDA's marketability?
Lower resistance rates confer a clinical advantage, making OJEMDA more appealing, especially as resistance to traditional options like mupirocin increases.

3. What are the main hurdles for OJEMDA’s global expansion?
Regulatory approval timelines, patent considerations, local healthcare policies, and establishing supply chains.

4. Is there a risk of generic entry post-patent expiry?
Yes, patent expiry around 2028 could lead to generics, impacting pricing and market share.

5. How do clinical trial results influence OJEMDA's long-term success?
Positive results expand approved indications, strengthen regulatory positioning, and enhance practitioner confidence; negative results could hamper growth.

---

References

[1] IQVIA. Global Topical Antibiotics Market Report. 2022.
[2] MarketWatch. Impetigo Treatment Market Trends and Forecasts, 2023-2030. 2023.
[3] EMA. Summary of Product Characteristics for OJEMDA. 2018.
[4] Global Data. Pediatric Skin Infection Management Analysis. 2021.
[5] FDA. Regulatory Pathways for Topical Antibiotics. 2022.