TWIRLA Drug Patent Profile

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

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-three 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

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

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
Argentina	030037	SISTEMA DE ADMINISTRACION DE ANTICONCEPTIVO TRANSDERMICO MEJORADO Y EL USO DE UNA CAPA DE SOPORTE Y UNA MATRIZ POLIMERICA PARA LA FABRICACION DE UN SISTEMA DE ADMINISTRACION DE ANTICONCEPTIVO
Austria	453374
Australia	1788301	Improved transdermal contraceptive delivery system and process
Australia	2004253593	Transdermal hormone delivery system: compositions and methods
Australia	2006201918	Improved transdermal contraceptive delivery system and process

Supplementary Protection Certificates for TWIRLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811

TWIRLA (levonorgestrel/ethinyl estradiol) investment scenario and patent-driven fundamentals analysis

Last updated: July 3, 2026

Executive summary: TWIRLA (levonorgestrel/ethinyl estradiol transdermal system) is a branded combined hormonal contraceptive (CHC) with FDA approval and an Orange Book-listed patent estate built around the specific drug product and its delivery system. Investment upside is constrained by the competitive CHC market and by the risk of earlier generic or authorized generic entry if key listed patents expire or are weakened via Hatch-Waxman or other challenges. The core diligence focus for investors is (1) Orange Book status and remaining listed patent/market exclusivities, (2) whether competitors have filed ANDAs for TWIRLA equivalent products, and (3) whether any formulation, method-of-use, or manufacturing patents create non-infringement or design-around difficulty for would-be generics.

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What patents protect TWIRLA (levonorgestrel/ethinyl estradiol) transdermal system in the US?

Featured snippet answer: TWIRLA’s US patent coverage is reflected in Orange Book-listed patents tied to the specific transdermal combination product and its related formulations and manufacturing/therapeutic claims. The enforceable scope is defined by the Orange Book listings for the exact FDA application/strength/dosage form and by the claims asserted in any litigation.

How the TWIRLA patent estate typically breaks down

For transdermal CHCs like TWIRLA, patent coverage in the US usually concentrates in four areas:

1. Drug product and formulation patents
   Claims may cover the adhesive matrix, drug load, release kinetics, and stability of levonorgestrel and ethinyl estradiol in a patch system.

2. Delivery system and manufacturing method patents
   Claims may cover fabrication steps, layer architecture, adhesive coating processes, and quality attributes that affect drug delivery.

3. Method-of-use patents
   Less common than product/formulation for CHCs, but present in some CHC portfolios when specific regimens or patient populations are claimed.

4. Regulatory exclusivity and non-patent barriers
   Periods like pediatric exclusivity (if applicable) or other granted exclusivities can extend market protection independent of patent expiration, but only for the exact FDA application and conditions.

Jurisdictional scope

Investment-relevant point: the US Orange Book governs US generic entry timing under Hatch-Waxman. Foreign counterpart patents matter for global licensing strategy, but the first commercial threats for US investors usually come from US filings and US injunction exposure.

TWIRLA investor diligence lens

• Identify each Orange Book-listed US patent (numbers), listed expiration, and listed submission dates by strength/form.
• Map each patent to whether it plausibly covers (i) composition/formulation, (ii) device structure or release system, or (iii) a method-of-use regimen.

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When does TWIRLA lose exclusivity and what are the key US expiration dates?

Featured snippet answer: TWIRLA loses exclusivity as Orange Book-listed patents expire and any granted exclusivities (if listed/associated with the product) end. The investable timing hinges on the latest-to-expire relevant listed patent plus any attached exclusivity.

Investor action: build a “last protection standing” timeline

A correct exclusivity timeline requires:

• Latest patent expiration date among Orange Book-listed patents for TWIRLA in the relevant dosage forms/strengths.
• Any pediatric exclusivity extension (if present) tied to the NDA.
• Any relevant regulatory exclusivity windows reflected in FDA records.

Why “latest patent” matters for earnings modeling

Generics usually time entry to the expiration of the last relevant listed patent that would be asserted as preventing launch. If the portfolio includes:

• multiple formulation or delivery patents expiring at different dates,
• one or more method-of-use patents expiring later, or
• a manufacturing patent that remains valid longer,
  then the “latest-to-expire” drives the launch calendar used by investors.

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Are there generic entry risks for TWIRLA via ANDA or biosimilar pathways?

Featured snippet answer: TWIRLA is a small-molecule CHC drug product, so the competitive threat is generic ANDAs and authorized generics, not biosimilars.

The generic entry risk model

For a patch product, ANDA entry depends on whether challengers can:

• make a bioequivalent transdermal formulation, and
• clear patent hurdles for the Orange Book-listed patents tied to that specific patch system.

Generic entry risk rises if:

• patents expire soon,
• challengers file Paragraph IV certifications,
• earlier litigation narrows claim scope or results in adverse court rulings,
• settlement agreements allow time-limited launch carveouts.

What specifically matters for transdermal CHCs

• Bioequivalence in transdermal systems is formulation- and delivery-dependent.
  Patch geometry, adhesive composition, and drug-release profile drive systemic exposure profiles.

• Design-around complexity can be high.
  If claims cover structural or functional characteristics tied to delivery system performance, challengers may need non-trivial redesign.

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What patent litigation affects TWIRLA and how do Paragraph IV challenges change launch timing?

Featured snippet answer: Patent litigation involving Paragraph IV certifications can delay generic launch through automatic 30-month stays, injunctions, or settlement carveouts. The actual impact depends on which Orange Book patents were challenged and the outcome.

How to read TWIRLA litigation risk for investors

For each known (or reported) TWIRLA case, investors should track:

• case caption and court (e.g., federal district court, Federal Circuit posture),
• asserted patents (numbers),
• Paragraph IV status and certification type,
• procedural milestones (Motions to dismiss, claim construction, summary judgment, trial),
• outcomes: invalidation, non-infringement, infringement findings, or settlement.

Settlement agreements

Even when courts do not issue a final merits decision, settlements typically define:

• “at risk” or non-infringing entry dates,
• design-around obligations,
• license fees (if any) and market allocation terms,
• stipulated injunctions or covenants not to sue.

These terms directly determine when a generic can enter without triggering damages or injunction.

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What is the Orange Book status of TWIRLA and which patents are listed for each dosage form/strength?

Featured snippet answer: The Orange Book lists TWIRLA’s patent-covered NDA drug product. The operative dataset for investors is the list of patents associated with the NDA and the strength/dosage form entries.

Orange Book mapping checklist (investment-grade)

For TWIRLA, the Orange Book analysis should produce a table with:

• NDA application number
• product name and strength
• dosage form (transdermal system)
• listed patent numbers
• patent type or description (as listed)
• earliest expiration date
• any later expiration date per patent
• status notes (e.g., “expires,” “extended,” “pediatric,” if reflected)

Why Orange Book completeness is critical

Modeling generic entry requires:

• correct identification of all listed patents tied to the exact product entry (same dosage form and strength),
• correct “last-to-expire” selection for launch timing,
• identification of patents that are likely to be asserted in litigation.

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How strong is the patent estate for TWIRLA compared with other combined hormonal contraceptive patches?

Featured snippet answer: TWIRLA’s relative strength depends on the number of still-expiring product/formulation and delivery-system patents and whether they cover core patch characteristics that generics must replicate or redesign around.

Comparison framework for CHC patches (investment lens)

Investors should compare TWIRLA to other CHC patch products and to oral CHCs on:

• number of Orange Book patents per product,
• remaining time to expiration for the latest-expiring patents,
• historical litigation intensity,
• patent scope breadth (product/formulation vs narrow method-of-use claims),
• feasibility of design-around (especially for transdermal delivery and adhesive systems).

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What formulations are protected by TWIRLA patents and what delivery-system features drive infringement risk?

Featured snippet answer: TWIRLA patent claims typically focus on the patch’s formulation and transdermal drug-release system. Infringement risk often hinges on adhesive matrix design, layer architecture, and drug release profiles that match claimed structural or functional parameters.

Technical claim themes that investors should expect

Transdermal combination products often have claim elements resembling:

• specific levonorgestrel and ethinyl estradiol load ranges,
• adhesive composition and tackifier ratios,
• polymer matrix structure for drug release,
• control of drug permeation through the skin,
• manufacturing parameters that yield consistent performance.

Design-around risk for ANDA competitors

Generic challengers may attempt:

• different adhesives/polymers with equivalent release profiles,
• altered layer thicknesses and geometries,
• different manufacturing methods that avoid process claim elements,
• non-infringing ranges if claims permit.

The probability of successful design-around correlates with how broad the independent claims are relative to core patch physics and chemistry.

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What regulatory status and FDA milestones affect TWIRLA commercialization and competition?

Featured snippet answer: TWIRLA’s competitive risk is shaped by FDA approvals, labeling, and any changes impacting substitutability. The regulatory pathway for generics is ANDA-based, and entry depends on bioequivalence and patent clearance.

Investment-relevant regulatory checkpoints

• Current FDA-approved labeling and indications (and any label expansions or restrictions).
• Post-approval safety communications that affect demand or switching behavior.
• Any manufacturing site changes (can affect supply stability and readiness for generic competition).
• Bioequivalence expectations that drive ANDA feasibility.

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Which companies are likely competitors for TWIRLA and how do launch scenarios differ?

Featured snippet answer: Competitors for TWIRLA include (1) brands in the CHC market and (2) generic filers that pursue ANDA approval of equivalent patch products. Launch scenarios depend on patent timing and whether challengers are prepared to meet transdermal bioequivalence.

Launch scenario modeling (3-case approach investors use)

1. No Paragraph IV filings:
   Branded exclusivity persists until patent expiration and any exclusivity ends. Generic entry is delayed.

2. Paragraph IV filings with ongoing litigation:
   A 30-month stay typically delays final launch, but actual entry depends on litigation outcomes or settlements.

3. Settlements or adverse outcomes:
   Entry may occur at settlement-defined dates, sometimes earlier than the latest-to-expire patent if non-infringement or invalidity is established for relevant claims.

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What are the biggest revenue exposure risks for TWIRLA from patent expiry, litigation, or formulary substitution?

Featured snippet answer: Revenue exposure is most sensitive to (i) the latest expiring Orange Book protection tied to transdermal product/formulation claims and (ii) formulary substitution dynamics in the CHC category, especially if a lower-cost patch becomes available.

Revenue risk channels

• Patent timing risk: the risk of earlier-than-modeled generic entry.
• Litigation risk: the risk that key patents are invalidated or narrowed.
• Substitution risk: plan and pharmacy benefits changes that accelerate switching when generics or authorized generics launch.
• Supply and manufacturing risk: patch product availability affects continuity and can raise competitive opportunities for substitutes.

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Key Takeaways

• TWIRLA’s investment case is driven by the remaining lifespan and enforceability of its Orange Book-listed patents for the transdermal combination product.
• The critical diligence artifact is the Orange Book-to-litigation mapping: which patents are listed, when each expires, and whether challengers filed Paragraph IV certifications against specific patents.
• Generic entry risk comes through ANDAs (not biosimilars) and is amplified by litigation outcomes and settlement-driven launch dates.
• For transdermal patches, formulation and delivery-system claim scope typically determines design-around feasibility and therefore the probability of a timely generic launch.

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FAQs

1. How does the latest-to-expire Orange Book patent control TWIRLA generic launch timing?
   The last expiring relevant listed patent typically defines the earliest lawful launch date absent a successful carveout (invalidity/non-infringement or settlement).

2. What does a Paragraph IV certification mean for TWIRLA competitiveness?
   It signals an ANDA filer’s intent to launch before patent expiration and triggers FDA-related timing stays and potential litigation that can delay or reshape entry.

3. Do transdermal CHC patches face higher generic design-around risk than oral CHCs?
   Yes, transdermal delivery-system attributes (adhesive and release mechanics) often create non-trivial product design and equivalence challenges.

4. What settlement terms most affect investment models for TWIRLA?
   Settlement-defined launch dates, carveouts, and covenants not to sue control when competitors can enter without infringement exposure.

5. What non-patent factors can accelerate TWIRLA demand erosion after generic entry?
   Formulary placement changes, payer tiering, and pharmacy switching behavior after lower-cost equivalents become available.

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References (APA)

1. FDA, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (US).
2. FDA: Hatch-Waxman Act framework and ANDA patent certification requirements (Paragraph IV, 30-month stay). (US).