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-six 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
Patent Applications:	460
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	8,747,888		Y
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020		RX	Yes	Yes	8,246,978		Y
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020		RX	Yes	Yes	9,050,348		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	8,221,784
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	7,045,145
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	8,883,196
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	8,221,785
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	7,384,650

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
Japan	2014159468	DERMAL DELIVERY DEVICE WITH IN SITU SEAL
Brazil	0015802	Sistema de administração de contraceptivo transdérmico, e, método para controlar a fertilidade, e para produzir um sistema de administração de contracptivo transdérmico
China	101897683	Transdermal hormone delivery system: compositions and methods
European Patent Office	2167001	DISPOSITIF D'ADMINISTRATION THERMIQUE AVEC SOUDURE ULTRASONORE (DERMAL DELIVERY DEVICE WITH ULTRASONIC WELD)
Israel	173152	TRANSDERMAL HORMONE DELIVERY SYSTEM AND METHOD FOR ITS MANUFACTURE
World Intellectual Property Organization (WIPO)	2009009651

Supplementary Protection Certificates for TWIRLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for Twirla

Introduction

Agile Therapeutics, a women’s healthcare company, has been making significant strides in the market with its innovative contraceptive patch, Twirla. This article delves into the market dynamics and financial trajectory of Twirla, highlighting key performance metrics, growth drivers, and future projections.

Product Overview

Twirla is a low-dose hormonal contraceptive patch, designed for weekly use. It is one of the first weekly hormonal contraceptive patches on the market, giving Agile Therapeutics a first-mover advantage[3].

Market Growth and Expansion

U.S. Contraceptive Market

The U.S. contraceptive market is substantial, valued at approximately $6 billion in 2023, with a projected annual growth rate of 4.6% through 2025. This expanding market provides a fertile ground for Agile Therapeutics to increase its market share[3].

Key States and Channels

Agile Therapeutics focuses on key states with large markets for contraceptives and strong reimbursement coverage for Twirla. The company also leverages telemedicine, particularly through its collaboration with Nurx, which has a patient network of over 1 million patients. Additionally, partnerships with organizations like Planned Parenthood and student health centers via the Afaxys customer network are crucial for growth in both retail and non-retail channels[4].

Financial Performance

Net Revenue

In 2023, Twirla delivered $19.6 million in net revenue, an 80% increase from the $10.9 million reported in 2022. This significant growth underscores the product's increasing acceptance and market penetration[1].

• Fourth Quarter 2023: Despite a 46% decrease in net revenue compared to the third quarter, primarily due to increased gross-to-net charges and a larger mix of non-retail business, the overall year showed robust growth[1].
• First Quarter 2024: Net revenue rebounded strongly, reaching $5.7 million, a 58% increase from the fourth quarter of 2023 and a 50% increase from the first quarter of 2023. This growth was driven by increased demand[2][5].

Demand and Factory Sales

Demand Growth

• Full Year 2023: Twirla demand was 243,841 total cycles, a 131% increase from the 105,741 cycles in 2022[1].
• Fourth Quarter 2023: Demand was 68,793 total cycles, a 7% decrease from the third quarter but still indicative of strong year-over-year growth[1].
• First Quarter 2024: Demand surged to 81,088 total cycles, an 18% increase from the fourth quarter of 2023 and an 80% increase from the first quarter of 2023[2][5].

Factory Sales

• Full Year 2023: Factory sales were 248,220 total cycles, a 117% increase from the 114,546 cycles in 2022[1].
• Fourth Quarter 2023: Factory sales were 68,580 total cycles, an 8% decrease from the third quarter but part of an overall strong year[1].
• First Quarter 2024: Factory sales increased to 70,662 cycles, a 3% increase from the fourth quarter of 2023 and a 63% increase from the first quarter of 2023[5].

Operating Expenses and Cost Management

Operating Expenses

Agile Therapeutics has been successful in managing its operating expenses. For the full year 2023, operating expenses decreased by 33% to $30.5 million from $45.5 million in 2022. This reduction was partly due to the company's decision to forgo bonuses for all employees in 2023[1].

• First Quarter 2024: Total GAAP operating expenses were $6.8 million, a 20% decrease from the comparable period in 2023[2][5].

Cost of Goods Sold (COGS)

COGS for the full year 2023 was $9.0 million, compared to $6.8 million in 2022. For the first quarter of 2024, COGS was $1.7 million, down from $2.2 million in the fourth quarter of 2023[1][2].

Growth Drivers

Product Innovations

Agile Therapeutics' focus on innovative contraceptive solutions is a key growth driver. Twirla's unique positioning as a weekly hormonal contraceptive patch has helped it capture a significant market share[3].

Market Expansions

The company's strategy to expand its reach through partnerships, telemedicine, and targeted marketing in key states has been instrumental in driving growth[4].

Strategic Partnerships

Partnerships with healthcare organizations and entities like Nurx and Planned Parenthood have enhanced distribution and accessibility for Twirla, contributing to its growth[4].

Investment in R&D

Agile Therapeutics plans to invest approximately $15 million in research and development to further solidify its product pipeline and innovation, which is expected to drive future growth[3].

Competitive Advantages

First Mover Advantage

Twirla's status as one of the first weekly hormonal contraceptive patches gives Agile Therapeutics a competitive edge in the market[3].

Strong Clinical Data

Clinical studies have shown that Twirla is effective in preventing pregnancy, which enhances its attractiveness to consumers and healthcare providers[3].

Strong Brand Recognition

As Agile Therapeutics grows its market presence, brand recognition is likely to increase consumer trust and drive sales[3].

Future Projections

Revenue Growth

Analysts project that Agile Therapeutics could achieve a revenue growth of 30-40% annually over the next five years, contingent on successful market penetration strategies and effective marketing of Twirla[3].

Market Penetration

The company aims to continue growing demand for Twirla in both retail and non-retail channels, with a focus on expanding its reach in telemedicine and strengthening relationships with key healthcare providers[2].

Key Takeaways

• Robust Revenue Growth: Twirla has demonstrated significant revenue growth, with an 80% increase in net revenue from 2022 to 2023.
• Strong Demand and Factory Sales: Despite some quarterly fluctuations, Twirla demand and factory sales have shown substantial year-over-year growth.
• Effective Cost Management: Agile Therapeutics has successfully reduced its operating expenses while maintaining growth momentum.
• Strategic Growth Initiatives: The company's focus on product innovations, market expansions, and strategic partnerships is expected to drive future growth.
• Competitive Advantages: Twirla's unique market positioning, strong clinical data, and growing brand recognition are key competitive advantages.

FAQs

What is Twirla and how does it differ from other contraceptives?

Twirla is a low-dose hormonal contraceptive patch designed for weekly use, making it one of the first weekly hormonal contraceptive patches on the market.

How has Twirla performed in terms of demand and factory sales?

Twirla demand and factory sales have shown significant year-over-year growth, with a 131% increase in demand and a 117% increase in factory sales from 2022 to 2023.

What are the key growth drivers for Twirla?

Key growth drivers include product innovations, market expansions through strategic partnerships and telemedicine, and investment in research and development.

How has Agile Therapeutics managed its operating expenses?

The company has reduced its operating expenses by 33% from 2022 to 2023, partly by forgoing bonuses for all employees in 2023.

What are the future revenue growth projections for Agile Therapeutics?

Analysts project a revenue growth of 30-40% annually over the next five years, contingent on successful market penetration strategies and effective marketing of Twirla.

Sources

1. Agile Therapeutics Reports Fourth Quarter & Full Year 2023 Financial Results and Provides Corporate Update. Agile Therapeutics.
2. Agile Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update. Agile Therapeutics.
3. Breaking Down Agile Therapeutics, Inc. (AGRX) Financial Health. DCF.
4. Agile Therapeutics Provides Updates on 2022 Twirla Performance and 2023 Commercial Plan. Biospace.
5. Agile Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update. GlobeNewswire.

Last updated: 2024-12-18