TWIRLA Drug Patent Profile

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

Twirla is a drug marketed by Agile and is included in one NDA. There are three patents protecting this drug.

This drug has nineteen patent family members in twelve countries.

The generic ingredient in TWIRLA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Twirla

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TWIRLA

International Patents:	19
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Drug Prices:	Drug price information for TWIRLA
What excipients (inactive ingredients) are in TWIRLA?	TWIRLA excipients list
DailyMed Link:	TWIRLA at DailyMed

See drug prices for TWIRLA

Pharmacology for TWIRLA

Drug Class	Estrogen Progestin Progestin-containing Intrauterine System
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

US Patents and Regulatory Information for TWIRLA

TWIRLA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020		RX	Yes	Yes			Y
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020		RX	Yes	Yes			Y
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020		RX	Yes	Yes			Y

Expired US Patents for TWIRLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020

International Patents for TWIRLA

When does loss-of-exclusivity occur for TWIRLA?

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

Georgia, Republic of

Hong Kong

Japan

New Zealand

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 TWIRLA around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	582565	DERMAL DELIVERY DEVICE WITH IN SITU SEAL
Germany	60043621
Eurasian Patent Organization	020208	УСТРОЙСТВО ДОСТАВКИ В КОЖУ С ИЗОЛИРУЮЩИМ СЛОЕМ IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)
Japan	2014159468	DERMAL DELIVERY DEVICE WITH IN SITU SEAL
World Intellectual Property Organization (WIPO)	2011088072

Supplementary Protection Certificates for TWIRLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

Market Dynamics and Financial Trajectory for TWIRLA: An In-depth Analysis

Last updated: July 28, 2025

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Introduction

TWIRLA, a prescription contraceptive transdermal patch developed and marketed by allure Medical, Inc., represents a notable advancement in hormonal contraception. Its formulation combines estrogen and progestin, delivered via a patch applied weekly, offering a non-invasive, user-friendly alternative to oral contraceptives. As a niche yet growing segment in women’s health, the drug’s market performance hinges on complex factors—regulatory approval, competitive landscape, payer dynamics, and shifting consumer preferences. This report analyzes these elements, providing insights into TWIRLA’s current market momentum and future financial trajectory.

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Market Landscape and Growth Drivers

1. Market Size and Segmentation

The global contraceptive market was valued at approximately USD 21.9 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.2% through 2030 [1]. Within this, hormonal contraceptives constitute a significant segment, with transdermal patches comprising a small but emergent niche. This segment benefits from the convenience and adherence advantages over oral pills.

2. Increasing Adoption of Non-Oral Contraceptive Methods

Consumers increasingly favor non-oral contraceptive options like patches, rings, and intrauterine devices, driven by concerns over compliance, side effects, and lifestyle compatibility. TWIRLA’s weekly application offers a competitive edge by reducing daily pill burden, aligning with this trend.

3. Regulatory and Prescriber Acceptance

TWIRLA gained FDA approval in 2020, with initial marketing in select markets [2]. Its reception has been aided by favorable safety profiles, though regulatory considerations around hormone-related risks impact physician prescribing patterns.

4. Demographic and Societal Influences

Global trends toward reproductive autonomy and the empowerment of women of reproductive age bolster demand. Additionally, education campaigns and improved access to healthcare enhance market penetration potential.

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Competitive Landscape

1. Portfolio of Contraceptive Options

TWIRLA competes with established products such as Ortho Evra (another transdermal patch), vaginal rings like NuvaRing, and oral contraceptives. The competitive edge hinges on administration frequency, side effect profile, cost, and user convenience.

2. Key Differentiators

TWIRLA differentiates through its innovative formulation, lower dose regimen, and potentially minimized hormone exposure. However, safety concerns regarding hormone-related risks necessitate ongoing pharmacovigilance.

3. Emerging Competitors

Other transdermal and non-hormonal devices in clinical or preclinical stages threaten future market share, emphasizing the need for continuous innovation and regulatory agility.

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Regulatory, Payer, and Reimbursement Dynamics

1. Regulatory Scrutiny

Regulatory agencies uphold stringent safety standards, especially concerning hormone therapy. TWIRLA’s labeling and safety communications influence prescriber confidence and patient uptake.

2. Payer Policies and Coverage

Reimbursement impacts patient access significantly. The affordability of TWIRLA compared to oral contraceptives influences prescribing behavior, with coverage often dictated by formularies and insurer preferences.

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Financial Trajectory and Revenue Forecast

1. Initial Market Adoption

Post-FDA approval, TWIRLA experienced moderate uptake, primarily driven by early adopter physicians and dedicated reproductive health clinics. However, initial sales faced challenges from cautious prescriber acceptance and reimbursement barriers.

2. Revenue Drivers

• Sales Volume Growth: Expansion into new geographic regions and increased awareness can accelerate sales.
• Pricing Strategy: Competitive pricing aligned with existing contraceptive options will be critical.
• Patient and Provider Education: Enhancing understanding of TWIRLA’s benefits broadens user base.

3. Long-term Potential

With projected market growth and increasing preference for non-invasive, user-friendly contraceptives, TWIRLA’s revenue could reach USD 200-300 million annually by 2030, assuming sustained market penetration and favorable regulatory conditions [3].

4. Risks and Challenges

• Safety and Side Effects: Reports of adverse events could hinder acceptance.
• Market Competition: Entry of alternative delivery systems poses threat.
• Regulatory Changes: Modifications in approval standards or messaging may affect sales strategies.

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Strategic Opportunities

• Product Differentiation: Innovate formulations to reduce side effects and improve efficacy.
• Partnerships: Collaborate with healthcare providers and insurers for broader access.
• Geographic Expansion: Enter emerging markets with growing reproductive health needs.
• Educational Campaigns: Promote awareness among prescribers and consumers to accelerate adoption.

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Conclusion

TWIRLA’s market dynamics are shaped by evolving consumer preferences, regulatory standards, and competitive pressures in the contraceptive landscape. While early-stage growth has been moderate, its unique delivery system and clinician-friendly profile position it favorably for scalable expansion. Financial trajectories will be primarily driven by strategic market penetration, payer acceptance, and continuous product optimization.

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Key Takeaways

• TWIRLA stands at the intersection of innovation and consumer demand for non-invasive contraception, offering significant growth potential.
• Market expansion hinges on overcoming regulatory hurdles and fostering payer and provider acceptance.
• Competitive pressures require continuous innovation and strategic differentiation.
• Long-term revenue prospects are optimistic, with potential to reach hundreds of millions annually, contingent on broader adoption strategies.
• Ongoing risk management and stakeholder engagement are crucial to realizing TWIRLA’s market and financial ambitions.

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FAQs

1. How does TWIRLA compare to traditional oral contraceptives in terms of adherence?
TWIRLA’s weekly patch reduces dosing frequency, improving adherence compared to daily pills, which enhances efficacy and patient satisfaction.

2. What safety concerns are associated with TWIRLA?
Similar to other hormonal contraceptives, TWIRLA carries risks related to thromboembolic events and hormonal side effects. Ongoing pharmacovigilance is essential to monitor safety.

3. Which demographics are most likely to adopt TWIRLA?
Women seeking non-daily, discreet contraception who prioritize convenience and are of reproductive age constitute the primary target demographic.

4. What strategies can manufacturers employ to increase market penetration?
Education campaigns, insurance negotiations, geographic expansion, and product enhancements are key strategies.

5. What is TWIRLA's outlook amid emerging contraceptive technologies?
Its success depends on differentiating through safety, efficacy, convenience, and acceptance. Innovations like biodegradable patches or non-hormonal options could influence future positioning.

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References

[1] Grand View Research. Contraceptive market size, trends, and forecast. 2022.
[2] FDA. TWIRLA (levonorgestrel and ethinyl estradiol) transdermal system approval. 2020.
[3] MarketWatch. Contraceptive market analysis and forecast. 2023.