Trametinib dimethyl sulfoxide - Generic Drug Details

What are the generic sources for trametinib dimethyl sulfoxide and what is the scope of freedom to operate?

Trametinib dimethyl sulfoxide is the generic ingredient in two branded drugs marketed by Novartis and Hikma, and is included in three NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trametinib dimethyl sulfoxide has one hundred and ninety-nine patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for trametinib dimethyl sulfoxide

International Patents:	199
US Patents:	9
Tradenames:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	16
Patent Applications:	2,030
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for trametinib dimethyl sulfoxide
DailyMed Link:	trametinib dimethyl sulfoxide at DailyMed

Recent Clinical Trials for trametinib dimethyl sulfoxide

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

Sponsor	Phase
University of California, San Francisco	PHASE2
Rising Tide Foundation	PHASE2
ECOG-ACRIN Cancer Research Group	Phase 2

See all trametinib dimethyl sulfoxide clinical trials

Pharmacology for trametinib dimethyl sulfoxide

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for trametinib dimethyl sulfoxide

G04BX	Other urologicals
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

M02AX	Other topical products for joint and muscular pain
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for TRAMETINIB DIMETHYL SULFOXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEKINIST	Tablets	trametinib dimethyl sulfoxide	0.5 mg and 2 mg	204114	1	2023-09-28

US Patents and Regulatory Information for trametinib dimethyl sulfoxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	9,271,941*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	7,378,423*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No	10,869,869*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes	8,835,443*PED				Y

International Patents for trametinib dimethyl sulfoxide

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4159205	NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Lithuania	4159217
South Korea	101911109
Denmark	1761528
Mexico	2012004413	COMBINACION. (COMBINATION.)
Argentina	122185	COMPRIMIDO FARMACÉUTICO QUE COMPRENDE EL SOLVATO DE DIMETILSULFÓXIDO DE LA N-3-[3-CICLOPROPIL-5-(2-FLUORO-4-YODO-FENILAMINO)-6,8-DIMETIL-2,4,7-TRIOXO-3,4,6,7-TETRAHIDRO-2H-PIRIDO[4,3-D]PIRIMIDIN-1-IL]FENILACETAMIDA, SU USO PARA PREPARAR UN MEDICAMENTO ÚTIL PARA TRATAR EL CÁNCER EN UN SER HUMANO Y PROCEDIMIENTO PARA PREPARAR DICHOS COMPRIMIDOS
South Korea	20120104547

Supplementary Protection Certificates for trametinib dimethyl sulfoxide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	1490063-3	Sweden		PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
1761528	PA2014039	Lithuania		PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528	300701	Netherlands		PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702
1761528	CA 2014 00055	Denmark		PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
1761528	68/2014	Austria		PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
1761528	CR 2014 00055	Denmark		PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140702
1761528	132014902315090	Italy		PRODUCT NAME: TRAMETINIB, OPZIONALMENTE NELLA FORMA DI UN SUO SALE, IDRATO O SOLVATO FARMACEUTICAMENTE ACCETTABILE(MEKINIST); AUTHORISATION NUMBER(S) AND DATE(S): EU/I/14/931/001-006, 20140702

Market Dynamics and Financial Trajectory for TRAMETINIB DIMETHYL SULFOXIDE

Last updated: August 7, 2025

Introduction

Trametinib Dimethyl Sulfoxide (DMSO) is an emerging compound within the oncology therapeutic landscape, primarily leveraged as part of combination regimens targeting BRAF-mutant melanoma and other cancers. While trametinib itself is well-established as a MEK inhibitor approved by the FDA in 2013, the DMSO (dimethyl sulfoxide) formulation's impact on the market remains under close scrutiny. This analysis explores the current market dynamics, historical and projected financial trajectories, and factors shaping this niche pharmaceutical segment.

Pharmacological Profile and Developmental Status

Trametinib functions as a highly selective MEK 1/2 inhibitor, disrupting downstream signaling of the MAPK pathway, critical in tumor proliferation and survival (1). Originally developed by GlaxoSmithKline (GSK), the drug's commercial success is predominantly rooted in its use for BRAF V600E melanoma, often in combination with BRAF inhibitors such as dabrafenib.

The DMSO formulation enhances drug stability, improves bioavailability, and can influence delivery modalities, especially in research and clinical trial phases. However, broader approval for DMSO formulations remains limited, rendering this a niche within the larger trametinib market.

Market Dynamics

1. Therapeutic Adoption and Indication Expansion

The global melanoma treatment market was valued at approximately USD 2.1 billion in 2021, driven by targeted therapies and immunotherapies (2). Trametinib's share is significant due to its efficacy with BRAF mutations. Its utility extends into non-melanoma cancers, including lung and colorectal malignancies, indicating growth potential.

The DMSO formulation's adoption is currently constrained, primarily used in clinical contexts rather than as a marketed standalone product. Its role in drug delivery research and formulation development provides an adjunct revenue stream but limits impact on overarching sales figures.

2. Regulatory Environment and Market Entry

Regulatory bodies like the FDA and EMA have stringent requirements for formulation-specific approvals. While trametinib is approved as a tablet, formulation variations, especially involving DMSO, need separate validation for safety and efficacy. This regulatory bottleneck delays commercialization, impacting revenue forecasts.

Emerging indications and expanded clinical trials could catalyze regulatory approvals for DMSO-based formulations, boosting market penetration.

3. Competitive Landscape

The targeted melanoma segment sees intense competition from immunotherapies (checkpoint inhibitors) and BRAF inhibitors. The MEK inhibitor class faces competitors such as cobimetinib and binimetinib, which offer alternative pathways.

In niche formulations involving DMSO, competition is limited but exists within research tools suppliers and custom formulation service providers. The integration of DMSO in drug delivery platforms offers differentiation but faces technological challenges, including toxicity concerns related to DMSO's permeation properties.

4. Geographic Market Dynamics

North America dominates the market owing to advanced healthcare infrastructure, high research activity, and robust pharma R&D funding. Europe follows, with increasing adoption driven by regulatory openness and heightened focus on melanoma and targeted treatments.

Emerging markets show potential, especially where local research institutions adopt innovative formulation techniques, including DMSO-based delivery systems.

Financial Trajectory Analysis

1. Historical Revenue Performance

Currently, direct revenues from DMSO formulations of trametinib are negligible in overall pharmaceutical sales, given the absence of approved DMSO-specific formulations. The primary income source remains from marketed trametinib tablets, which generated approximately USD 600 million globally in 2021 (2).

Research and development investments in DMSO formulations, including synthesizing stability studies and safety assessments, total in the tens of millions annually but are primarily classified under R&D expenditure.

2. Forecasted Growth Patterns

Modeling the financial trajectory involves considering clinical trial outcomes, regulatory approvals, and indication expansion:

• Short-term (1-3 years): Expect minimal revenue impact from DMSO formulations due to ongoing clinical assessments Ongoing studies into novel delivery systems and combination therapies could lead to incremental revenue increases, especially if DMSO formulations prove superior in delivery or stability.

• Medium-term (3-5 years): Potential approval of DMSO-based formulations for specific indications could generate revenues ranging from USD 50 million to USD 150 million annually, contingent on the scope of indications and market adoption rates.

• Long-term (beyond 5 years): With successful clinical translation, DMSO formulations could carve a niche in personalized medicine strategies, potentially contributing to a larger share of the MEK inhibitor market.

3. Key Revenue Drivers

• Clinical trial outcomes: Positive results can hasten regulatory approvals.
• Formulation advantages: Improved pharmacokinetic profiles or reduced adverse effects could enhance market penetration.
• Partnerships and licensing agreements: Collaborations with biotech firms or research institutions can accelerate commercialization.

4. Investment and Cost Considerations

Formulation development, regulatory submission, and commercialization efforts will require upfront investments, estimated at USD 10-20 million per clinical trial phase. The cost-to-market ratio remains high, emphasizing the importance of strategic partnerships and early-stage licensing.

Emerging Trends and Market-Shaping Factors

• Personalized Medicine: DMSO formulations could facilitate targeted delivery, minimizing systemic toxicity.
• Nanotechnology Integration: Coupling DMSO with nanocarriers can enhance drug delivery, opening new avenues for revenue.
• Regulatory Evolution: Agencies are increasingly recognizing innovative formulations, which may streamline approval pathways.

Risks and Challenges

• Toxicological concerns: DMSO's permeation properties risk systemic toxicity if misused.
• Limited market coverage: Regulatory hurdles restrict rapid commercialization.
• Competition from other delivery platforms: Liposomal, nanoparticle, and conjugate systems may overshadow DMSO-based formulations.

Conclusion

While the standalone financial contribution of trametinib DMSO formulations remains modest today, the potential for future growth hinges on successful clinical validation, regulatory acceptance, and strategic industry partnership development. The current market landscape favors incremental adoption, with significant upside if DMSO-based delivery methods demonstrate clear therapeutic advantages.

---

Key Takeaways

• Market Opportunity: The primary value of trametinib DMSO formulations resides in research and specialized delivery systems, with limited direct sales historically.
• Growth Drivers: Indication expansion, technological advances, and regulatory approvals are critical for revenue scaling.
• Competitive Edge: DMSO offers unique permeability features but must address safety concerns and regulatory challenges.
• Strategic Importance: Partnerships with biotech firms and investment in formulation research can unlock commercial potential.
• Risk Management: Thorough toxicological profiling and regulatory navigation are essential to mitigate development and market entry risks.

---

FAQs

1. What are the main therapeutic uses of trametinib?
   Trametinib is primarily used for treating BRAF V600E mutant melanoma, often in combination with BRAF inhibitors, and is being explored for other cancers such as non-small cell lung carcinoma and colorectal cancer.

2. Why is DMSO formulation significant in pharmaceutical applications?
   DMSO enhances drug solubility and permeability, facilitating delivery of compounds that are otherwise challenging to administer effectively, particularly in research and experimental therapies.

3. What regulatory challenges does trametinib DMSO face?
   Since DMSO formulations are often experimental, they require rigorous safety and efficacy data for approval, which can delay commercialization and market entry.

4. How competitive is the market for MEK inhibitors like trametinib?
   The market is highly competitive, with drugs like cobimetinib and binimetinib competing in similar indications. Differentiation relies on efficacy, safety, and formulation innovations.

5. What is the long-term outlook for trametinib DMSO formulations?
   Success depends on clinical validation of delivery advantages; if proven, DMSO-based formulations could carve a niche, particularly in personalized medicine and targeted delivery applications.

---

References

1. Flaherty KT, et al. "Inhibition of mutated BRAF in metastatic melanoma." New England Journal of Medicine, 2012.
2. MarketLine. "Global Melanoma Treatment Market Report," 2022.