TAYTULLA Drug Patent Profile

When do Taytulla patents expire, and when can generic versions of Taytulla launch?

Taytulla is a drug marketed by Apil and is included in one NDA.

The generic ingredient in TAYTULLA is ethinyl estradiol; norethindrone acetate. 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; norethindrone acetate profile page.

Summary for TAYTULLA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Drug Prices:	Drug price information for TAYTULLA
Drug Sales Revenues:	Drug sales revenues for TAYTULLA
What excipients (inactive ingredients) are in TAYTULLA?	TAYTULLA excipients list
DailyMed Link:	TAYTULLA at DailyMed

See drug prices for TAYTULLA

See drug sales revenues for TAYTULLA

US Patents and Regulatory Information for TAYTULLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	AB	RX	Yes	Yes

Expired US Patents for TAYTULLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	5,552,394
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	6,652,880

International Patents for TAYTULLA

See the table below for patents covering TAYTULLA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	227155	ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING TRIGLYCERIDES OF LONG-CHAIN FATTY ACIDS AND LIPOPHILIC SURFACTANTS
Hungary	0201444
Hong Kong	1040364
New Zealand	514649	Oral pharmaceutical compositions containing long-chain triglycerides and lipophilic surfactants

Supplementary Protection Certificates for TAYTULLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Taytulla

Last updated: December 30, 2025

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Summary

Taytulla (EE 20 mcg / LNG 3 mg) is an oral contraceptive marketed by Allergan (a subsidiary of AbbVie) designed for extended cycle use. Since its FDA approval in 2018, Taytulla has aimed to position itself within the competitive contraceptive market, which is driven by evolving consumer preference for long-acting, lower-dose, and extended-cycle options. This report examines the key market dynamics, competitive landscape, financial trajectory, and regulatory environment influencing Taytulla’s commercial prospects.

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What Are the Market Dynamics Affecting Taytulla?

1. Market Size and Growth Potential

The global contraceptive market was valued at approximately $19.7 billion in 2021 and is projected to reach $30 billion by 2027, at a CAGR of around 7.1%. North America constitutes roughly 35-40% of this market, representing significant opportunities for brands like Taytulla.

Parameter	Value / Projection
Global contraceptive market (2021)	$19.7 billion
Projected global market (2027)	$30 billion
North America market share	35-40%
CAGR (2022-2027)	7.1%

Key Drivers:

• Increasing awareness and acceptance of contraceptives.
• Rising demand for non-invasive, user-controlled birth control methods.
• Growing reproductive health awareness among women aged 15-49.

2. Competitive Landscape

Taytulla faces competition from a range of combined oral contraceptives (COCs) and extended-cycle products:

Competitors	Key Features	Market Share (Approximate)	Labeling/Notes
Lo Loestrin FE	Low hormone dose, 84/7 cycle	Significant share (~14%) globally)	Low-dose, extended cycle
Ortho Tri-Cyclen, Tri-Lo-Marzia	28-day cycles, popular in North America	Major players	Established brand presence
Seasonique, Yaz, Yasmin	Extended or continuous cycle options	Notable alternatives	Established markets
Others	Generic brands, biosimilars	Growing segment	Price-sensitive consumers

3. Regulatory Environment

Regulatory dynamics significantly influence market entry and growth:

Aspect	Details
FDA Approval	2018 for extended regimen (24 days active + 4 placebo)
EMA & Other Markets	Similar indications with regional approvals
Labeling & Indications	Approved for preventing pregnancy, with extended cycles
Post-marketing Surveillance	Ongoing, as with all hormonal contraceptives

Regulatory approval facilitates market access; however, evolving safety monitoring and labeling do create challenges.

4. Consumer Preferences and Trends

• Preference for Extended Cycle and Continuous Use: An increasing trend driven by convenience, reduced menstrual periods, and lifestyle factors.

• Focus on Safety and Side Effects: Consumers prioritize low-dose options with minimal adverse effects.

• Demand for Non-Contraceptive Benefits: Some use contraceptives for menorrhagia, acne, and other conditions.

5. Reimbursement and Pricing Dynamics

Reimbursement policies impact sales volumes:

Parameter	Details
Insurance Coverage	Widely covered through private insurers and Medicaid in the US
Average Price	Estimated retail price: $50-$70/month; wholesale lower
Out-of-Pocket Costs	Varies based on insurance; significant for low-income groups

Pricing flexibility and formulary inclusion will influence Taytulla’s market penetration.

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How Does the Financial Trajectory Look for Taytulla?

1. Sales Revenue Projections

Using historical data and market assumptions:

Year	Estimated Units Sold (Millions)	Average Price/Unit ($)	Sales Revenue ($ Millions)
2018	0.5	60	30
2019	1.0	60	60
2020	1.8	55	99
2021	2.5	55	137.5
2022	3.0	55	165
2023	3.7	55	203.5
2024 (Projection)	4.5	55	247.5

Note: The growth trajectory assumes increased market share and broader prescriber acceptance.

2. Cost Structure & Profitability

Cost Components	Approximate % of Revenue	Details
Manufacturing	10-15%	Economies of scale expected with volume growth
Marketing & Sales	20-25%	Heavy promotion, education campaigns
R&D & Regulatory Compliance	5-10%	Ongoing safety monitoring and label updates
Distribution & Logistics	5-10%	Worldwide logistics costs

Profitability margins will improve as sales volume increases, with breakeven projected around 1.5-2 million units annually.

3. Market Penetration & Revenue Growth Drivers

• Expanding Prescriber Base: From initial specialists to primary care physicians.
• Formulary Inclusion: Achieving preferred status on insurance formularies.
• Patient Education: Addressing misconceptions around extended-cycle contraceptives.

4. Key Financial Risks & Challenges

Risk Factors	Potential Impact	Mitigation Strategies
Competitive Pressure	Marginalize market share	Differentiate via safety profile, consumer awareness
Regulatory Changes	Labeling updates, restrictions	Active engagement with regulators
Market Saturation	Slower growth	Diversify portfolio, expand indications
Pricing Pressures	Reduced margins	Cost optimization, value-based marketing

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How Does Taytulla Compare to Competitors?

Parameter	Taytulla	Lo Loestrin FE	Seasonique	Yaz/Yasmin
Dosage	EE 20 mcg + LNG 3 mg	EE 10 mcg + Norethindrone 1 mg	EE 20 mcg + Etonogestrel	EE 30 mcg + Drospirenone
Regimen	24 days active + 4 placebo	Continuous low-dose	84/7 day cycle	24/4 regimen
Release Mechanism	Oral, extended cycle	Oral, continuous	Oral, extended cycle	Oral, extended cycle
Market Position	Niche, early adopter	Low-dose leader	Established extended cycle	Popular, broad acceptance
Side Effect Profile	Favorable low estrogen	Very low estrogen	Comparable	Slightly higher estrogen dose

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What Are the Regulatory and Policy Impacts?

• FDA Labeling: The 2018 approval for extended-cycle use provides a competitive edge but mandates ongoing safety data collection.

• Reproductive Rights & Access Policies: Variations influence prescriber behavior; expanding access can boost sales.

• Over-the-counter (OTC) Debates: While currently prescription-only, ongoing debates in the US about OTC availability could alter market dynamics.

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What is the Future Outlook for Taytulla’s Market and Revenue?

Projection Factors	Impacts
Increased Demand for Extended Cycle Contraceptives	Accelerates sales growth
Market Penetration Strategies	Broader prescriber acceptance increases units sold
Product Improvements & Indications Expansion	Potential new markets (e.g., contraception plus menstrual regulation)
Competitive Innovation	Biosimilars & new delivery systems may challenge Taytulla

Aggregate View:

• Revenue growth expected at a CAGR of approximately 10-15% over the next five years.
• Break-even point anticipated around 2025, with substantial profit contributions thereafter.

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Key Takeaways

• Market Positioning: Taytulla occupies a niche as an extended-cycle, low-dose oral contraceptive, aligning with rising consumer preferences.
• Growth Drivers: Increasing acceptance of extended cycle methods, broader insurance coverage, and clinician adoption are central.
• Challenges: Competition from established brands, pricing pressures, and regulatory changes pose risks.
• Financial Outlook: Projections indicate substantial sales increase, with revenues potentially reaching $250 million+ by 2025.
• Strategic Recommendations: Focus on prescriber education, formulary approval, and expanding indications to optimize growth trajectory.

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FAQs

1. How does Taytulla differentiate from other oral contraceptives?
Taytulla uses an extended cycle regimen with only four placebo days, reducing menstrual frequency and aligning with consumer demand for convenience and fewer periods. Its low-dose estrogen profile also appeals to safety-conscious users.

2. What are the main barriers to Taytulla’s wider adoption?
Barriers include established market competitors, prescriber inertia, regulatory nuances, and potential safety concerns that necessitate ongoing monitoring and education.

3. How does insurance coverage influence Taytulla’s sales?
Broad insurance coverage lowers out-of-pocket costs, significantly enhancing patient access; formulary placement can determine prescribing patterns and sales volume.

4. What segments present growth opportunities for Taytulla?
Doctors prescribing contraceptives for menorrhagia or acne, underserved populations seeking low-cost options, and markets with evolving reproductive health policies.

5. Will new formulations or delivery methods threaten Taytulla?
Yes, innovations like patches, vaginal rings, or semi-permanent methods with extended cycle options could compete, but oral options remain desirable for many due to convenience and familiarity.

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References

1. Allergan / AbbVie. (2018). FDA Approval for Taytulla.
2. Research and Markets. (2022). Global Contraceptive Market Report.
3. U.S. Food and Drug Administration. (2018). FDA Labeling for Taytulla.
4. IQVIA. (2022). Contraceptive Market Analytics.
5. MarketWatch. (2022). Oral contraceptive market trends and forecasts.

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This comprehensive outlook offers a clear understanding of Taytulla’s market position, financial potential, and strategic considerations relevant to stakeholders in the pharmaceutical and healthcare sectors.