ELLA Drug Patent Profile

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

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.

The generic ingredient in ELLA is ulipristal acetate. There is one drug master file entry 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

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Patent Applications:	755
Drug Prices:	Drug price information for ELLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELLA
What excipients (inactive ingredients) are in ELLA?	ELLA excipients list
DailyMed Link:	ELLA at DailyMed

See drug prices for ELLA

Pharmacology for ELLA

Drug Class	Progesterone Agonist/Antagonist
Mechanism of Action	Selective Progesterone Receptor Modulators

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
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes			Y
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes			Y
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes			Y

EU/EMA Drug Approvals for ELLA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratoire HRA Pharma	ellaOne	ulipristal acetate	EMEA/H/C/001027Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.	Authorised	no	no	no	2009-05-15
Gedeon Richter Plc.	Ulipristal Acetate Gedeon Richter	ulipristal acetate	EMEA/H/C/005017Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.	Withdrawn	no	no	no	2018-08-27

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	2010237120
Brazil	PI1014035
Canada	2757496
China	102395373
Cyprus	1118236
Denmark	2419108
European Patent Office	2419108

Ella (ulipristal acetate 30 mg) Market Dynamics and Financial Trajectory (Revenue, Pricing, and Competitive Pressure)

Last updated: July 23, 2026

ella is the brand of ulipristal acetate 30 mg tablet for emergency contraception (EC). In the US, it faces a stable but structurally price-pressured market defined by pharmacist- and clinic-channel demand, fast switching to generics and competing EC products, and periodic re-contracting tied to payer and pharmacy benefit policies. In the near term, the financial trajectory is driven less by clinical differentiation and more by (1) product availability across channels, (2) how quickly net pricing falls after generic/authorized competition, and (3) persistent competition from levonorgestrel EC and alternative ulipristal formulations/brands in certain geographies.

Below is the market structure and the main dynamics shaping ella’s revenue path, plus what matters for forecasting, licensing posture, and competitive entry risk.

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How big is the emergency contraception market for ella, and what are the demand drivers?

ella sits inside the emergency contraception category, typically supplied through retail pharmacy and online fulfillment, with smaller pull-through via sexual health clinics, urgent care, and family planning networks.

What drives purchase frequency in emergency contraception?

Key demand drivers are operational rather than biological:

• Time-critical behavior: conversion is strongest within hours after unprotected intercourse and erodes as time-to-dose increases.
• Channel availability: late-night/after-hours retail access and pharmacy stocking affect fill rates.
• Guideline adherence: EC prescribing and patient counseling patterns follow national guidance and local formularies.
• Retail price and copay: net revenue responds to payer rules and pharmacy discount programs more than to list price.

Where does ella compete most directly?

• Levonorgestrel EC tablets (single-dose and multi-brand supply) for price-sensitive segments.
• Other ulipristal acetate products where authorized equivalents exist by country and channel.
• Non-pill EC approaches (eg, copper IUD) in clinician-led segments, which can divert demand from EC pills.

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What is ella’s competitive landscape versus levonorgestrel EC and other ulipristal products?

Clinical differentiation matters less than switching risk

In the EC category, ulipristal acetate is often perceived as having advantages in certain scenarios, including efficacy relative to levonorgestrel across time windows and weight/BMI considerations as described in labeling and guidance. That perception can support brand retention at the margin, but it does not prevent:

• Generic erosion of branded pricing once cost-effective alternatives become available in a given geography.
• Formulary and pharmacy procurement switching when net pricing compresses.

Competitor set that shapes ella net revenue

The competitive set is typically defined by:

• Levonorgestrel EC brands and generics that are often positioned as the default low-cost pill option.
• Ulipristal acetate equivalents (brand and authorized versions) that track ulipristal’s premium in some markets but cannot sustain high list pricing once authorized competition broadens.

Implication for financial trajectory

• If ella remains the premium ulipristal option without strong authorized generic pressure in a geography, net pricing can hold longer.
• Where ulipristal competition accelerates, ella revenue tends to flatten and then decline as share shifts to cheaper pills.

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What patents protect ella, and how do patent and exclusivity timelines affect revenue?

What matters for ella’s revenue outlook

For EC products, financial trajectory is strongly correlated with:

• Patent expiry of active-ingredient and key formulation/process IP.
• Orange Book (US) status and whether key patents are tied to the brand’s tablet composition, dosage form, or manufacturing process.
• Paragraph IV challenge activity and any litigation that delays generic entry.

Why this is central to market dynamics

Once generic or authorized competition enters, brand revenue typically:

1. Drops quickly due to retail preference switching.
2. Stabilizes at a smaller base if the brand maintains channel relationships, patient inertia, or clinician preference.
3. Declines further if pricing discipline by competitors expands into pharmacy networks.

However, no reliable patent estate, Orange Book listing status, or litigation timeline data is included in the information available in this prompt. A patent-driven revenue model requires specific patent numbers, expiry dates, and any exclusivity grants tied to the NDA.

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What is the FDA regulatory status of ella, and how does it influence entry risk for generics?

Regulatory facts that drive market entry

Regulatory status influences generic timing through:

• NDA approval and listed patents (Orange Book).
• Generics pathway: ANDA with Paragraph IV or Paragraph III, and whether required patents are actively litigated.
• Exclusivity events: new clinical studies (data exclusivity), patent term adjustments, and pediatric exclusivity (if applicable).
• Labeling and REMS: EC typically has no REMS-driven constraints, so label content and patent listing are the practical gating factors.

Financial impact mechanism

• ANDAs filed reduce forward brand negotiating leverage with wholesalers and pharmacy groups because buyers price in imminent generic entry.
• 30-month stay periods (for Paragraph IV) can delay erosion, creating a temporary plateau in revenue.
• At-launch substitution produces step-down revenue and margin compression.

This analysis cannot provide a factual FDA/Orange Book status summary without source-specific regulatory inputs, including Orange Book patent lists and ANDA litigation records, which are not present in the prompt.

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When does ella lose exclusivity, and when do generics typically launch?

Exclusivity and launch timing shapes

A standard launch-risk framework for EC brands depends on:

• Earliest expiry among listed composition and formulation patents.
• Any market exclusivity tied to the regulatory approval (data exclusivity and related exclusivities).
• Whether generic manufacturers file promptly and win Paragraph IV leverage.

Expected financial profile after expiry

Once the effective exclusivity window closes:

• First generic/authorized entrant causes the sharpest net price drop.
• Subsequent entrants can continue to drive down acquisition price to pharmacies and distributors.
• Brand sales often shift to segments not fully served by generic pricing or where brand availability is prioritized.

No specific ella exclusivity/expiry dates are supplied in the prompt, so this section cannot be completed with factual dates.

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What formulation and method-of-use protections affect ella’s pricing power and litigation risk?

Formulation and process IP that typically matters

In EC pills, enforcement and settlement dynamics often revolve around:

• Dosage form composition and tablet characteristics (core excipients, coatings).
• Stability and dissolution parameters tied to manufacturing method.
• Method-of-manufacture claims if the generic must use an equivalent process or face IP barriers.

Method-of-use

For EC, method-of-use IP tends to have less commercial impact than composition/formulation because labeling is often broad and clinical use is straightforward. Still, if any method-of-use claims are listed, they can:

• Trigger ANDA design-around strategies.
• Strengthen brand positions in settlement negotiations.

Specific patent claim coverage cannot be enumerated without patent identifiers and claim charts, which are not provided.

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What patent litigation affects ella, and what settlements shape generic entry?

Litigation-driven revenue timing

Patent litigation affects financials via:

• Injunction threats and court outcomes.
• Settlement timing that dictates launch date for first generic entrants.
• Design-around clauses that can delay or limit market substitution.

Why litigation data is mandatory for an actionable trajectory

Without:

• case caption(s),
• litigated patent numbers,
• filing and settlement dates,
• and any agreed launch dates, it is not possible to translate litigation posture into a credible revenue curve.

No litigation record is included in the prompt.

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How does ella’s revenue trajectory compare with other emergency contraception brands?

Typical cross-brand pattern in EC

Even without brand-specific financial statements, EC brands often show a consistent relative pattern:

• Brand leaders with cost advantages due to channel contracts can hold higher net revenue longer.
• Price compression accelerates after generic/authorized competition expands.
• Retail formulary and national pharmacy chains tend to standardize stocking decisions after generic availability is clear.

What to watch for in ella specifically

• Persistence of ulipristal premium pricing versus levonorgestrel low-cost options.
• Generic competitive intensity in the same geography.
• Distribution contract renewal cycles.

Comparative financials require audited revenue data or credible estimates for ella and peers, which are not included in the prompt.

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What generic entry risks exist for ella, and how fast can substitution occur?

Substitution speed

EC is a product where:

• patients often accept substitutes due to urgency,
• pharmacies can switch procurement quickly,
• and prescribers may defer to the pharmacy’s stocking.

This makes the substitution curve steep when a lower-cost alternative becomes available.

Key risk factors

• Number of ANDA or authorized generic entrants
• Pharmacy chain formulary selection and copay placement
• Patient access via online pharmacies
• Distributor willingness to stock and market the brand under margin pressure

No ella generic-entry timeline is provided in the prompt, so a quantified risk forecast cannot be produced.

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How strong is the patent estate for ella versus generic encroachment?

How patent strength translates into commercial outcomes

Patent strength impacts:

• how early ANDAs are filed,
• whether litigation delays entry,
• settlement leverage, and
• the extent to which generics can launch “at risk.”

Patent estate assessment requirements

A credible strength score requires:

• patent count by family,
• remaining claim scope at present,
• enforceability indicators (injunction history, litigation outcomes),
• and whether key patents are composition, formulation, or manufacturing.

No patent-family data for ella is provided in the prompt, so this section cannot be completed with hard metrics.

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Commercial implications: what does ella’s trajectory mean for licensing, partnerships, and investment?

Licensing and commercialization

In EC, licensing and partnerships are often tied to:

• manufacturing and supply reliability,
• channel access through retail pharmacy and distributor relationships,
• and defense of net pricing through exclusivity periods.

If exclusivity is near-term or already eroded, licensing focus tends to shift to:

• contracted distribution,
• brand differentiation messaging,
• and cost reduction rather than premium pricing.

Investment framing

Investors generally view EC products as:

• high-velocity but commoditizing once generics enter,
• margin-sensitive,
• and highly sensitive to regulatory and patent-driven entry timing.

A monetizable investment view requires concrete revenue or earnings references and the exclusivity/entry calendar, which are not included in the prompt.

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Key Takeaways

• ella is positioned in the emergency contraception category where demand is time-sensitive and channel availability and net pricing determine outcomes.
• Revenue trajectory is typically governed by generic/authorized competition cycles and how quickly pharmacy procurement switches from branded to lower-cost alternatives.
• Patent and exclusivity timelines, Paragraph IV activity, and settlement launch dates are the primary determinants of the shape of ella’s revenue curve.
• This prompt does not contain the patent, Orange Book, litigation, or audited financial inputs needed to provide ella-specific dates or a quantified financial trajectory.

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FAQs

1) How do pharmacy benefit design and copay placement typically affect sales of emergency contraception brands like ella?
Copay and plan tier placement drive immediate purchase decisions, especially when patients seek fastest access through retail.

2) Do emergency contraception products show strong seasonality that can change ella’s quarterly revenue?
Seasonality can exist via sexual health visit patterns and retail purchasing, but the urgency-driven nature of EC often reduces volatility versus chronic therapies.

3) What pricing pressure is typical after generic ulipristal or low-cost levonorgestrel entrants launch?
Net pricing usually compresses quickly as pharmacies normalize procurement to the lowest-cost stocked option and shift marketing to generics.

4) How do international differences in ulipristal approvals affect ella’s global commercialization?
Country-specific authorization of ulipristal formulations and local generic competition determine whether the brand holds premium pricing or is rapidly commoditized.

5) What regulatory events most often delay generic entry for emergency contraception products?
Orange Book-listed patent enforcement and Paragraph IV litigation stays or settlements are the main timing levers.

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References (APA)

1. No sources are provided in the prompt for ella’s FDA status, patent estate, litigation, or financial performance.