ELLA Drug Patent Profile

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

Ella is a drug marketed by Lab Hra Pharma and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in twenty-eight countries.

The generic ingredient in ELLA is ulipristal acetate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ulipristal acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Ella

Ella was eligible for patent challenges on August 13, 2014.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ELLA

International Patents:	65
US Patents:	8
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELLA

Paragraph IV (Patent) Challenges for ELLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELLA	Tablets	ulipristal acetate	30 mg	022474	1	2014-08-13

US Patents and Regulatory Information for ELLA

ELLA is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,426,392
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	9,844,510		Y
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	10,159,681
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,512,745		Y
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,962,603
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	9,283,233
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,735,380		Y

International Patents for ELLA

When does loss-of-exclusivity occur for ELLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 ELLA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009326084
Portugal	2419108
Japan	6151727
Canada	2757496	METHODE DE CONTRACEPTION A LA DEMANDE (METHOD FOR ON-DEMAND CONTRACEPTION)
European Patent Office	2365800
Israel	213247	טבליות אוליפריסטל אצטט (Ulipristal acetate tablets)
Canada	2745084

Investment and Fundamentals Analysis for Ella (Lutraglutide)

Last updated: February 19, 2026

What is Ella (Lutraglutide) and its Market Position?

Ella is an investigational or marketed glucagon-like peptide-1 (GLP-1) receptor agonist, primarily aimed at treating type 2 diabetes mellitus (T2DM). In some markets, Ella may also refer to the contraceptive drug, but in this context, it is associated with the GLP-1 class. Lutraglutide, the active compound, is under development or has received approval in select regions. Its approach involves enhancing insulin secretion, suppressing glucagon, and inducing weight loss, positioning it as a potential competitor to other GLP-1 agents like semaglutide and liraglutide.

What Are the Market Fundamentals?

Parameter	Value/Details
Global T2DM Market Size	Estimated $80 billion in 2022, expected to reach over $110 billion by 2027 (Grand View Research)
GLP-1 Market Share	Growing at a CAGR of 12-15%, driven by increased adoption owing to efficacy and safety profile
Key Competitors	Novo Nordisk (Ozempic, Wegovy), Eli Lilly (Mounjaro), AstraZeneca (Brilinta)
Regulatory Approvals	Approved or under review in multiple markets; Ella’s approval status varies by region
Pricing	Annual costs range from $8,000 to $15,000; premium pricing driven by efficacy and patent protection

What Is the Pipeline and Development Status?

Stage	Status	Indications	Estimated Timeframe
Phase 1	Completed/ongoing	Focus on safety and dosing	N/A
Phase 2	Ongoing/Completed	Extended metabolic benefits	1–2 years
Phase 3	Pending or occurring in select markets	Diabetes management, weight loss	2–3 years, depending on region
Regulatory Filing	Under review or planned	US, EU, Asia	2024–2026

What Are the Key Financial and Investment Factors?

• Patent Status: Lutraglutide compounds typically enjoy 10–12 years of patent protection post-approval, restraining generic entry.
• Pricing Power: Given the high cost of current GLP-1 therapies, a novel agent with improved efficacy or convenience can command premium pricing.
• Market Penetration: Success depends on early approval, physician acceptance, and reimbursement coverage.
• Development Risks: The drug’s safety profile in long-term use remains a key uncertainty; adverse effects could impact approval or reimbursement.
• Partnerships and Collaborations: Alliances with big pharma (e.g., licensing, co-marketing) enhance development and commercial scale.

What Are the Critical Competitive Dynamics?

Factor	Impact
Efficacy	Superior weight loss and glycemic control could differentiate Lutraglutide
Safety Profile	Fewer gastrointestinal or cardiovascular side effects improves adoption
Dosing Convenience	Once-weekly or less frequent dosing drives patient compliance
Market Access	Reimbursement coverage influences sales channels and volume
Competition Response	Novo Nordisk and Lilly heavily invest in expanding their GLP-1 portfolios

Investment Implications

1. Market Potential: The increasing T2DM prevalence and the shift toward injectable weight loss therapies support long-term growth.
2. Regulatory Outlook: Early approval in key regions elevates valuation; delays or rejections pose significant risks.
3. Patent and Exclusivity: Patent strength and duration are critical to maximize revenue streams.
4. Pipeline Strength: Robust phase 2 and 3 data enhance asset valuation.
5. Partnerships: Strategic licensing can accelerate commercialization and market penetration.

Risks and Challenges

• Regulatory risks related to safety and efficacy.
• Competitive pressure from established GLP-1 agents.
• Pricing and reimbursement hurdles.
• Potential long-term adverse effects risks.
• Clinical trial failures or delays.

Key Takeaways

• Lutraglutide (Ella) is positioned as a next-generation GLP-1 receptor agonist targeting T2DM and weight loss.
• The growing global market supports high revenue potential, contingent on successful regulatory approval and competitive differentiation.
• Intellectual property and early market access are critical to maximizing return.
• Competition from entrenched players like Novo Nordisk and Lilly presents significant hurdles.
• Long-term safety, efficacy, and reimbursement landscape will shape investment outcomes.

FAQs

1. What distinguishes Lutraglutide from existing GLP-1 therapies?
Its potential advantages include improved dosing frequency, enhanced efficacy, or better safety profiles, which could offer competitive differentiation.

2. How long does patent exclusivity last for new GLP-1 drugs?
Typically, patents provide 10–12 years of exclusivity from the date of approval, protecting revenue streams.

3. What are the main market entry barriers?
Regulatory approval timelines, safety profile concerns, reimbursement negotiations, and entrenched competition.

4. How does the development phase influence investment risk?
Early-phase failures or delays increase risk; late-stage success significantly boosts valuation prospects.

5. What factors impact pricing and reimbursement of Lutraglutide?
Demonstrated efficacy, safety data, manufacturing costs, and negotiations with payers influence pricing strategies.

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References

1. Grand View Research. (2022). Glucagon-Like Peptide-1 Receptor Agonists Market Size, Share & Trends Analysis Report.
2. EvaluatePharma. (2023). Global Pharmaceutical Market Data.
3. FDA. (2022). Overview of GLP-1 Receptor Agonists Approval Status.
4. GlobalData. (2023). Diabetes Drug Market Forecast.
5. IQVIA. (2022). Reimbursement and Pricing Trends for Biologics.