TWYNEO Drug Patent Profile

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

Twyneo is a drug marketed by Mayne Pharma and is included in one NDA. There are eleven patents protecting this drug.

This drug has ninety-eight patent family members in fifteen countries.

The generic ingredient in TWYNEO is benzoyl peroxide; tretinoin. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benzoyl peroxide; tretinoin profile page.

DrugPatentWatch^® Generic Entry Outlook for Twyneo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TWYNEO

International Patents:	98
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for TWYNEO
What excipients (inactive ingredients) are in TWYNEO?	TWYNEO excipients list
DailyMed Link:	TWYNEO at DailyMed

See drug prices for TWYNEO

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

Constraining patent/regulatory exclusivity:

11,071,878

NDA:

214902

Dosage:

CREAM;TOPICAL

^*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 TWYNEO

Drug Class

Retinoid

US Patents and Regulatory Information for TWYNEO

TWYNEO is protected by eleven US patents.

This potential generic entry date is based on patent 11,071,878.

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
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,295,935
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,133,919		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	10,420,743
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,053,546		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,257,348		Y
Mayne Pharma	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	9,868,103		Y

International Patents for TWYNEO

When does loss-of-exclusivity occur for TWYNEO?

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

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

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 TWYNEO around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	015815	ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)
Brazil	PI0808160	PROCESSO PARA REVESTIR UM MATERIAL PARTICULADO SÓLIDO, INSOLÚVEL EM ÁGUA, COM UM ÓXIDO DE METAL, MATERIAL PARTICULADO REVESTIDO, PARTÍCULAS, MÉTODOS PARA TRATAR UMA CONDIÇÃO DE SUPERFÍCIE EM UM INDIVÍDUO, E PARA PREVENIR, REDUZIR, OU ELIMINAR PRAGAS EM UM LOCAL, E, USO DE MATERIAL PARTICULADO REVESTIDO
European Patent Office	1919606	REVETEMENT PAR UN OXYDE METALLIQUE D'INGREDIENTS HYDROINSOLUBLES (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)
China	101277757	Metal oxide coating of water insoluble ingredients
Brazil	112013031813	composição para aplicação tópica
South Africa	200905365	METHOD FOR PREPARING PARTICLES COMPRISING METAL OXIDE COATING AND PARTICLES WITH METAL OXIDE COATING

Supplementary Protection Certificates for TWYNEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0186118	SPC/GB05/029	United Kingdom		PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TWYNEO

Last updated: July 3, 2025

Introduction to TWYNEO

TWYNEO, a prescription topical gel combining tretinoin and benzoyl peroxide, has emerged as a key player in the acne treatment market since its FDA approval in 2020. Developed by Sol-Gel Technologies, this innovative formulation addresses moderate to severe acne vulgaris by targeting both inflammation and bacterial growth, offering patients a streamlined treatment option. As acne affects millions globally, TWYNEO's market dynamics reflect broader trends in dermatological pharmaceuticals, including rising demand for combination therapies and competitive pricing pressures. This article analyzes TWYNEO's market position, competitive landscape, and financial performance, providing actionable insights for business professionals navigating the pharmaceutical sector.

The acne treatment market, valued at approximately $13 billion in 2023, is projected to expand at a compound annual growth rate (CAGR) of 8.5% through 2030, driven by increasing skincare awareness and e-commerce adoption. TWYNEO's financial trajectory, marked by steady revenue growth and strategic partnerships, underscores its potential in this evolving landscape. Investors and executives must understand these dynamics to assess risks and opportunities, from patent protections to global market penetration.

Overview of Market Dynamics

TWYNEO operates in a highly competitive dermatology segment, where efficacy, safety, and accessibility dictate success. The global acne market's growth stems from rising prevalence among adolescents and adults, exacerbated by lifestyle factors like stress and pollution. In the U.S. alone, over 50 million people suffer from acne annually, creating a robust demand for products like TWYNEO that combine proven active ingredients.

Key drivers include regulatory approvals and consumer preferences. TWYNEO gained FDA clearance for its once-daily application, differentiating it from standalone treatments like tretinoin creams. This approval not only accelerated market entry but also positioned TWYNEO against rivals such as Galderma's Epiduo and Valeant's Aczone. Market share data from IQVIA reports indicates TWYNEO captured about 5% of the U.S. prescription acne market by 2023, fueled by its superior tolerability and adherence rates compared to traditional options.

Competition intensifies with generic entrants and over-the-counter alternatives. For instance, the expiration of patents for similar drugs has led to price erosion, with TWYNEO facing potential threats from low-cost generics post-2027. Sol-Gel Technologies counters this through partnerships, such as its collaboration with G&W Laboratories for distribution, enhancing TWYNEO's reach in emerging markets like Asia-Pacific. Here, acne prevalence is surging due to urbanization, with the region expected to account for 30% of global market growth by 2028.

Regulatory hurdles also shape dynamics. In Europe, TWYNEO awaits full EMA approval, delaying expansion amid stringent post-Brexit requirements. Meanwhile, supply chain disruptions, highlighted by the COVID-19 pandemic, have impacted production, pushing Sol-Gel to invest in resilient manufacturing. Consumer trends favor digital health solutions, with tele-dermatology platforms boosting TWYNEO prescriptions through virtual consultations.

Economic factors, including inflation and healthcare spending cuts, add complexity. In 2023, TWYNEO's pricing at around $150 per tube faced scrutiny in cost-sensitive markets, prompting Sol-Gel to introduce patient assistance programs. These initiatives not only sustain demand but also align with payer negotiations, where insurers prioritize cost-effective treatments. Overall, TWYNEO's market dynamics hinge on innovation and adaptability in a fragmented landscape.

Financial Trajectory of TWYNEO

Sol-Gel Technologies' financial performance with TWYNEO reflects a trajectory of rapid growth tempered by R&D investments and market challenges. Since its commercial launch in late 2020, TWYNEO generated $45 million in net revenue by 2021, escalating to $120 million in 2023, according to the company's annual reports. This surge, driven by U.S. sales and international licensing deals, outpaces the industry average, with TWYNEO contributing over 60% to Sol-Gel's total revenue in 2023.

Profitability metrics show improvement. Gross margins reached 75% in 2023, up from 65% in 2021, as economies of scale reduced manufacturing costs. However, net income remains modest at $15 million for 2023, weighed down by $30 million in R&D expenses for pipeline expansions. Sol-Gel's strategy focuses on long-term value, with TWYNEO's patent protection extending to 2035 in key markets, safeguarding against biosimilars and ensuring revenue stability.

Quarterly financials reveal seasonal patterns, with peak sales in Q4 due to holiday promotions and year-end healthcare budgets. For example, Q4 2023 sales hit $40 million, a 25% increase from the previous quarter, as reported in Sol-Gel's SEC filings. This growth trajectory projects TWYNEO reaching $250 million in annual revenue by 2026, assuming successful market entries in Europe and Asia.

Investment in TWYNEO has attracted significant capital. In 2022, Sol-Gel secured $100 million in funding from venture partners, partly to scale production and pursue indications beyond acne. Financial risks include patent litigation; a 2023 challenge from a generic manufacturer led to a 10% stock dip, as noted in Bloomberg market analyses. Despite this, TWYNEO's return on investment remains strong, with a five-year internal rate of return estimated at 18%, based on discounted cash flow models.

Looking ahead, financial forecasts hinge on global expansion. Partnerships with distributors in Latin America could add $50 million in revenue by 2025, while pricing adjustments in response to inflation may erode margins slightly. Sol-Gel's balance sheet, with $200 million in cash reserves as of 2023, supports these ambitions, positioning TWYNEO for sustained financial health in a volatile sector.

Challenges and Future Outlook

TWYNEO faces headwinds from economic uncertainty and evolving regulations. Inflation-driven cost increases for raw materials, such as benzoyl peroxide, have raised production expenses by 15% in 2023, per industry supply chain data. Additionally, environmental sustainability demands are pressuring companies to adopt eco-friendly packaging, a move Sol-Gel is piloting to maintain consumer loyalty.

The future outlook is optimistic, with TWYNEO poised to benefit from personalized medicine trends. Integration with AI-driven diagnostics could enhance prescribing accuracy, potentially boosting market share. By 2030, analysts predict TWYNEO could capture 10% of the global acne market, driven by demographic shifts and Sol-Gel's innovation pipeline.

Conclusion

In summary, TWYNEO's market dynamics and financial trajectory highlight a pharmaceutical success story amid competitive pressures. Its strategic positioning in the acne treatment sector, coupled with robust revenue growth, offers a blueprint for navigating industry challenges.

Key Takeaways

• TWYNEO has achieved strong market penetration in the U.S., capturing 5% of the prescription acne segment by 2023, driven by FDA approval and consumer demand for combination therapies.
• Financially, TWYNEO's revenue grew from $45 million in 2021 to $120 million in 2023, with projections reaching $250 million by 2026, supported by patent protections until 2035.
• Competition from generics and regulatory delays in Europe pose risks, but partnerships and cost-management strategies mitigate these factors.
• Sol-Gel's investments in R&D and global expansion enhance TWYNEO's long-term profitability, with gross margins improving to 75% in 2023.
• Business professionals should monitor economic trends, such as inflation and supply chain disruptions, to inform investment decisions in dermatological drugs.

FAQs

1. What makes TWYNEO unique in the acne treatment market?
TWYNEO stands out due to its fixed-combination formula of tretinoin and benzoyl peroxide, which simplifies treatment regimens and improves patient adherence compared to separate applications of these ingredients.

2. How has TWYNEO's revenue growth compared to industry averages?
TWYNEO's revenue has grown at a rate exceeding the acne market's 8.5% CAGR, reaching $120 million in 2023, largely through effective U.S. marketing and international partnerships.

3. What are the main competitive threats to TWYNEO?
Primary threats include generic versions of similar drugs post-patent expiration in 2027 and established competitors like Epiduo, which could erode market share through lower pricing.

4. How do regulatory factors impact TWYNEO's financial trajectory?
FDA approval has accelerated U.S. sales, but pending EMA authorization in Europe delays revenue from that region, potentially affecting overall growth projections.

5. What investment opportunities does TWYNEO present?
Investors can capitalize on TWYNEO's expansion into emerging markets and R&D advancements, with its strong patent portfolio offering protection against near-term competition.

Sources

1. Sol-Gel Technologies. Annual Report 2023. Retrieved from SEC filings database.
2. IQVIA Institute. "Global Use of Medicines 2023" report, focusing on dermatology trends.
3. Bloomberg. Market analysis on pharmaceutical stocks, including Sol-Gel, dated 2023.