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TWYNEO Drug Patent Profile

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

Twyneo is a drug marketed by Galderma Labs Lp and is included in one NDA. There are seven patents protecting this drug.

This drug has sixty-three patent family members in thirteen 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:	63
US Patents:	7
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 seven US patents and one FDA Regulatory Exclusivity.

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
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	9,868,103		Y
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	11,071,878		Y
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	12,070,629		Y
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	10,420,743
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	10,653,899		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	201200347
Australia	2006274541	Metal oxide coating of water insoluble ingredients
Eurasian Patent Organization	200970724	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ПЕРОКСИД И РЕТИНОИД
Mexico	363379	FORMULACIONES TÓPICAS ESTABILIZADAS QUE CONTIENEN MICROCÁPSULAS DE NÚCLEO-CUBIERTA. (STABILIZED TOPICAL FORMULATIONS CONTAINING CORE-SHELL MICROCAPSULES.)
World Intellectual Property Organization (WIPO)	2008093346
Eurasian Patent Organization	200800512	ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ

Supplementary Protection Certificates for TWYNEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
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
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
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

TWYNEO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TWYNEO

Introduction to TWYNEO

TWYNEO, a topical cream formulation of 0.1% tretinoin and 3% benzoyl peroxide, is a groundbreaking treatment for acne vulgaris in adults and pediatric patients 9 years of age and older. Developed by Sol-Gel Technologies, TWYNEO has been making significant waves in the dermatological market since its launch.

Market Acceptance and Prescriber Uptake

Since its launch in April 2022, TWYNEO has seen robust uptake by prescribers. The recurring base of prescribers, which indicates the percentage of prescribers who continue to prescribe the drug after initial use, has been exceptionally high. By the first quarter of 2023, this base had increased to 98%, up from 82% in the fourth quarter of 2022. This high recurrence rate is a strong indicator of the drug's acceptance and effectiveness within the dermatology community[3][5].

Prescription Volume and Patient Refills

The positive trends in prescriber uptake have translated into significant prescription volumes. According to IQVIA data, over 28,000 prescriptions were written for TWYNEO in the first quarter of 2023 alone. Additionally, patient refill rates have been increasing, further solidifying the drug's position in the market[3].

Regulatory and Licensing Agreements

Sol-Gel Technologies has entered into strategic licensing agreements to expand TWYNEO's reach. Notably, an agreement with Searchlight Pharma aims to commercialize TWYNEO and another Sol-Gel product, EPSOLAY, in Canada. This deal includes upfront payments of up to $11 million, regulatory and sales milestones, and additional royalties ranging from low double-digits to high teens. This partnership not only introduces TWYNEO to Canadian patients but also provides non-dilutive capital for Sol-Gel[1].

Financial Performance

The financial trajectory of TWYNEO is closely tied to its commercial success. Sol-Gel Technologies has reported revenue from TWYNEO sales through its partnership with Galderma. In the third quarter of 2022, Sol-Gel received $0.3 million in license revenue from Galderma, resulting from the sales of TWYNEO and EPSOLAY. While this figure is lower than the previous year due to the phasing of licensing revenues, the overall trend indicates a growing royalty stream aligned with volume growth[5].

Research and Development Expenses

The development and launch of TWYNEO have been accompanied by significant research and development (R&D) investments. However, as the drug has transitioned from the development phase to commercialization, R&D expenses related to TWYNEO and EPSOLAY have decreased. In the third quarter of 2022, R&D expenses were $2.0 million, down from $6.0 million in the same period in 2021. This reduction reflects the successful transition of these products to the market[5].

General and Administrative Expenses

General and administrative expenses have also seen a decline, primarily due to reduced professional services. In the third quarter of 2022, these expenses were $1.8 million, compared to $2.1 million in the same period in 2021. This efficiency in operational costs contributes to the overall financial health of Sol-Gel Technologies[5].

Cash Runway and Funding

Sol-Gel Technologies has a cash runway that extends into the second half of 2025, supported by various funding activities. For instance, the company announced the pricing of $22.8 million in parallel registered direct and private placement offerings in the first quarter of 2023. These funds are intended to support the Phase 3 trial of another drug candidate, patidegib, and for general corporate purposes[3].

Market Growth and Competitive Landscape

The dermatological OTC drugs market, particularly the acne segment, is expected to grow significantly. The launch of TWYNEO, as the first and only 0.1% tretinoin and 3% benzoyl peroxide combination cream, has been a key driver of this growth. The market is anticipated to register a CAGR of nearly 4.3% over the forecast period, with product launches and strategic partnerships like those involving Sol-Gel and Galderma contributing to this expansion[4].

Geographical Expansion

In addition to its presence in the U.S. market, TWYNEO is set to expand into other geographies. The licensing agreement with Searchlight Pharma is expected to introduce TWYNEO to Canadian patients, with regulatory submissions anticipated in early 2024. This expansion is part of Sol-Gel's strategy to generate revenue from international markets and build a global presence for its products[1].

Industry Comparisons and Benchmarks

Galderma, a major player in the dermatology sector, has reported significant growth in its therapeutic dermatology segment, which includes products like TWYNEO. Galderma's record net sales of $2.2 billion in the first half of 2024, with a 10.8% year-on-year growth, highlight the robust demand for dermatological treatments. This growth is driven by volume increases and favorable product mix, indicating a strong market environment for products like TWYNEO[2].

Expert Insights and Quotes

Alon Seri-Levy, PhD, Chief Executive Officer of Sol-Gel Technologies, has expressed satisfaction with the growth trajectory of TWYNEO and EPSOLAY. "We are very pleased with the continued growth trajectory for both TWYNEO and EPSOLAY and the effective commercial efforts of our partner, Galderma," he stated. This positive feedback from industry leaders underscores the market acceptance and commercial success of TWYNEO[5].

Key Statistics and Metrics

• Prescriber Uptake: 98% recurring base of prescribers by Q1 2023[3].
• Prescription Volume: Over 28,000 prescriptions written in Q1 2023[3].
• Revenue: $0.3 million in license revenue from Galderma in Q3 2022[5].
• R&D Expenses: Decreased from $6.0 million in Q3 2021 to $2.0 million in Q3 2022[5].
• Cash Runway: Extended into the second half of 2025[3].

Conclusion

TWYNEO has established itself as a significant player in the dermatological market, particularly in the treatment of acne vulgaris. With strong prescriber uptake, increasing prescription volumes, and strategic licensing agreements, the financial trajectory of TWYNEO looks promising. As Sol-Gel Technologies continues to expand its product portfolio and geographical reach, TWYNEO is poised to remain a key contributor to the company's growth and success.

Key Takeaways

• High Prescriber Uptake: TWYNEO has a high recurring base of prescribers, indicating strong market acceptance.
• Growing Prescription Volumes: Over 28,000 prescriptions were written in Q1 2023, reflecting increasing demand.
• Strategic Licensing: Agreements with companies like Searchlight Pharma are expanding TWYNEO's reach into new markets.
• Financial Performance: Revenue from TWYNEO sales is contributing to Sol-Gel's financial health, with a growing royalty stream.
• Geographical Expansion: TWYNEO is set to enter the Canadian market, further expanding its global presence.

Frequently Asked Questions

Q: What is TWYNEO used for? A: TWYNEO is used for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

Q: Who developed TWYNEO? A: TWYNEO was developed by Sol-Gel Technologies.

Q: What are the key ingredients in TWYNEO? A: TWYNEO contains 0.1% tretinoin and 3% benzoyl peroxide.

Q: How has the prescriber uptake for TWYNEO been? A: The recurring base of prescribers for TWYNEO has been exceptionally high, reaching 98% by Q1 2023.

Q: What are the financial implications of TWYNEO for Sol-Gel Technologies? A: TWYNEO has contributed to Sol-Gel's revenue through license agreements and royalties, with a growing royalty stream aligned with volume growth.

Sources:

1. Sol-Gel and Searchlight Pharma Announce Licensing Agreements to Commercialize TWYNEO® and EPSOLAY® in Canada. Sol-Gel Technologies.
2. Galderma delivers record net sales of 2.2 billion USD and 10.8% year-on-year net sales growth on a constant currency basis. Galderma.
3. Sol-Gel Technologies Reports First Quarter 2023 Financial Results and Provides Corporate Update. Sol-Gel Technologies.
4. Dermatological OTC Drugs Market Size & Share Analysis. Mordor Intelligence.
5. Sol-Gel Technologies Reports Third Quarter 2022 Financial Results and Provides Corporate Update. Sol-Gel Technologies.