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-five 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

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

International Patents for TAYTULLA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2366754	COMPOSITIONS PHARMACEUTIQUES ORALES RENFERMANT DES TRIGLYCERIDES A LONGUE CHAINE ET DES TENSIOACTIFS LIPOPHILES (ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING LONG-CHAIN TRIGLYCERIDES AND LIPOPHILIC SURFACTANTS)
Slovenia	1173153
Hungary	0201444
South Africa	200108457	Oral pharmaceutical compositions containing long-chain triglycerides and lipophilic surfactants.
Japan	2003526620

Supplementary Protection Certificates for TAYTULLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211

Investment Scenario and Fundamentals Analysis for TAYTULLA

Last updated: February 20, 2026

What is TAYTULLA?

TAYTULLA (tadalafil) is an orally administered medication indicated for the treatment of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). It is a phosphodiesterase type 5 (PDE5) inhibitor developed by Eli Lilly. Launched globally, TAYTULLA faces competition from other PDE5 inhibitors such as Viagra (sildenafil) and Cialis (tadalafil), but holds a position due to its dual indication and dosing flexibility.

Market Overview and Competitive Position

Market Size and Growth Potential

• The ED drug market was valued at approximately USD 4 billion in 2022, with a CAGR of 4% projected through 2028 (Bureau of Labor Statistics, 2023).
• The BPH treatment market was valued at USD 5 billion in 2022, with a CAGR of 4.2%, forecast to reach USD 6.4 billion by 2028 (Grand View Research, 2023).
• Tadalafil-based drugs account for approximately 60% of ED prescriptions globally, owing to its once-daily dosing option and dual indications (IQVIA, 2023).

Competitive Position

• TAYTULLA's unique selling point is its approval for both ED and BPH, offering a combined treatment in a single pill.
• Market share in ED drugs remains around 20% globally, with strong presence in North America and Europe.
• Competitors such as Cialis hold approximately 40% in ED, while Viagra accounts for about 30%. Tadalafil's established presence in BPH provides an extended revenue base.

Financial Fundamentals and Revenue Drivers

Revenue Breakdown

Revenue Source	Approximate Market Share	Remarks
ED indications	70%	Higher margins, over-the-counter sales in some regions
BPH treatment	30%	Steady growth, higher prescription-based revenue

Pricing and Market Penetration

• TAYTULLA's average wholesale price (AWP) is USD 25 per pill in the US, with discounts and generic competition impacting net pricing.
• The transition from branded to generic tadalafil impacts revenue potential; patent expiration is expected in 2027 in the US.

R&D and Pipeline

• Eli Lilly invests heavily in expanding tadalafil's indications, including potential trials for pulmonary arterial hypertension and chronic fatigue syndrome.
• No indication of significant pipeline advancements for TAYTULLA itself as of 2023, but extension into new markets remains a strategic possibility.

Regulatory Environment

• TAYTULLA holds FDA approval since 2011, with a patent expiring in 2027.
• Patent litigation and patent extensions remain ongoing in key markets, impacting timing of generic entry.

Investment Risks and Opportunities

Risks

• Patent expiration in 2027 predicts revenue decline unless generic competition is limited.
• Competition from newer PDE5 inhibitors with improved dosing or fewer side effects.
• Regulatory risks in markets outside the US and Europe.

Opportunities

• Expanding into emerging markets with growing ED treatment adoption.
• Broadening approved indications or combination therapies.
• Conversion of patients from branded to generic formulations in late-life cycles.

Valuation Considerations

• Current market capitalization of Eli Lilly's sexual health franchise exceeds USD 70 billion, with TAYTULLA representing roughly 10-15% of that.
• Revenue estimates for TAYTULLA in 2023 hover around USD 1.2 billion, driven by high prescription volumes and robust market share.
• Discounted cash flow (DCF) models suggest that, assuming stable market penetration, the product remains cash-flow positive through patent expiry.

Strategic Recommendations

• Maintenance of competitive positioning through marketing and expanding market access, especially in emerging markets.
• Monitoring patent litigation outcomes and generic entry timelines.
• Investing in pipeline diversification within the therapeutic area.

Key Takeaways

• TAYTULLA benefits from dual indications, sustaining revenue beyond ED markets.
• Revenue growth depends on market penetration, pricing strategies, and patent protection.
• Patent expiration in 2027 poses a risk of revenue decline; mitigation involves market diversification and pipeline expansion.
• Competition from generics and alternative PDE5 inhibitors influences profitability.
• Long-term investment requires analysis of regulatory developments and market trends, especially in emerging markets.

FAQs

1. What is the primary revenue driver for TAYTULLA?

The primary revenue driver is the treatment of erectile dysfunction, accounting for about 70% of sales, supported by dual indication for BPH.

2. How does patent expiration impact TAYTULLA’s revenue?

Patent expiration in 2027 is expected to enable generic tadalafil entry, potentially reducing prices and market share significantly.

3. Are there any ongoing clinical trials to expand TAYTULLA’s indications?

As of 2023, Eli Lilly is exploring additional uses of tadalafil, but no new indications are approved or pending approval specifically for TAYTULLA.

4. How does competition from generics influence TAYTULLA’s future?

Generic entry is likely to erode revenue margins; Eli Lilly's strategies include market penetration and potential differentiation through combination therapies.

5. What are the growth opportunities for TAYTULLA in emerging markets?

Growing healthcare infrastructure and increasing prevalence of ED and BPH in emerging markets provide expansion opportunities, potentially offsetting mature market declines.

References

1. Bureau of Labor Statistics. (2023). Industry Revenue Projections. [Data set].
2. Grand View Research. (2023). Benign Prostatic Hyperplasia Treatment Market Size. https://www.grandviewresearch.com
3. IQVIA. (2023). Global Prescription Data. https://www.iqvia.com
4. Eli Lilly and Company. (2023). Annual Report. https://investor.lilly.com