ADCIRCA Drug Patent Profile

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

Adcirca is a drug marketed by Eli Lilly Co and is included in one NDA.

The generic ingredient in ADCIRCA is tadalafil. There are twenty-five drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adcirca

A generic version of ADCIRCA was approved as tadalafil by TEVA PHARMS USA on May 22^nd, 2018.

Summary for ADCIRCA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	23
Patent Applications:	7,070
Drug Prices:	Drug price information for ADCIRCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADCIRCA
What excipients (inactive ingredients) are in ADCIRCA?	ADCIRCA excipients list
DailyMed Link:	ADCIRCA at DailyMed

See drug prices for ADCIRCA

Recent Clinical Trials for ADCIRCA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Washington University School of Medicine	Phase 1
The Curtis L. Brown Glioblastoma Research Fund	Phase 1
Shanghai Institute of Materia Medica, Chinese Academy of Sciences	Phase 2

See all ADCIRCA clinical trials

Pharmacology for ADCIRCA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Paragraph IV (Patent) Challenges for ADCIRCA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADCIRCA	Tablets	tadalafil	20 mg	022332	1	2009-10-15

US Patents and Regulatory Information for ADCIRCA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	AB2	RX	Yes	Yes

EU/EMA Drug Approvals for ADCIRCA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Limited	Talmanco (previously Tadalafil Generics)	tadalafil	EMEA/H/C/004297Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.	Authorised	yes	no	no	2017-01-09
Eli Lilly Nederland B.V.	Tadalafil Lilly	tadalafil	EMEA/H/C/004666Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Lilly is not indicated for use by women.Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.	Authorised	no	no	no	2017-03-22
Eli Lilly Nederland B.V.	Adcirca (previously Tadalafil Lilly)	tadalafil	EMEA/H/C/001021AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.	Authorised	no	no	no	2008-10-01
Eli Lilly Nederland B.V.	Cialis	tadalafil	EMEA/H/C/000436Treatment of erectile dysfunction.In order for tadalafil to be effective, sexual stimulation is required.Cialis is not indicated for use by women.	Authorised	no	no	no	2002-11-12
Mylan Pharmaceuticals Limited	Tadalafil Mylan	tadalafil	EMEA/H/C/003787Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Mylan is not indicated for use by women.	Authorised	yes	no	no	2014-11-21

International Patents for ADCIRCA

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	556	Tetracyclic derivatives, process of preparation and use.
African Regional IP Organization (ARIPO)	9500712
Argentina	003455	DERIVADOS TETRACICLICOS, SU USO EN LA PREPARACION DE UN MEDICAMENTO, UN METODO DE TRATAMIENTO, UNA COMPOSICION FARMACEUTICA Y PROCESOS PARA LAPREPARACION DE UNA COMPOSICION FARMACEUTICA Y PARA PREPARAR LOS COMPUESTOS.
Austria	169018
Austria	216997
Austria	327756
Australia	1574895

Supplementary Protection Certificates for ADCIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0740668	SPC004/2003	Ireland		SPC004/2003, 20040610, EXPIRES: 20171111
0740668	91017	Luxembourg
0740668	PA2003001	Lithuania		PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
0740668	300124	Netherlands		300124, 20150119, EXPIRES: 20171111
0740668	SPC/GB03/007	United Kingdom		PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
0740668	PA2003001,C0740668	Lithuania		PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
0740668	CA 2003 00008	Denmark

Adcirca (tadalafil) Market Dynamics and Financial Trajectory: Sales Drivers, Competition, and Exclusivity Path

Last updated: June 8, 2026

Adcirca (tadalafil) generates revenue primarily from pulmonary arterial hypertension (PAH) and, via dosing and switching patterns, from broader erectile dysfunction (ED) demand elasticity in tadalafil-class markets. Financial performance is driven by PAH patient growth and persistence, payer mix, generics entry dynamics for tadalafil oral products, and the extent to which Adcirca retains share versus alternative PAH therapies (including endothelin receptor antagonists, prostacyclin pathway agents, and combination regimens).

What market dynamics shape Adcirca (tadalafil) sales in PAH and how fast is demand moving?

Adcirca is a branded, once-daily tadalafil formulation positioned for PAH. Demand is influenced by:

• PAH prevalence growth and diagnosis rates in treated markets.
• Clinical switching between PAH agents based on guideline updates, tolerability, and formulary access.
• Combination therapy adoption, where tadalafil often gains share as part of multi-drug regimens rather than as monotherapy.

What are the main demand drivers by payer and treatment channel?

• Commercial payer coverage: Pharmacy benefit coverage and step-edit rules determine persistence after initial titration.
• Specialty pharmacy distribution: Impacts patient acquisition costs and adherence, which directly drives prescription renewals.
• Institutional formulary decisions: Large accounts can shift share quickly when a formulary is updated.

How do PAH guideline trends affect Adcirca utilization?

• Guideline-driven movement toward earlier combination regimens can expand tadalafil volume if access is maintained.
• If newer or preferred agents dominate formularies, Adcirca’s growth slows even if total PAH prescriptions rise.

Which companies compete with Adcirca and how does tadalafil-class substitution change pricing power?

Adcirca’s competitive set is two-layered:

1. Direct PAH therapy competition (different drug classes used for pulmonary hypertension).
2. Tadalafil substitution pressure from lower-cost tadalafil products in markets where generic tadalafil is available and interchangeable.

How does PAH class competition typically affect tadalafil share?

• Endothelin receptor antagonists (for example, ambrisentan, bosentan, macitentan depending on geography and guideline standing).
• Prostacyclin pathway agents (inhaled, oral, and parenteral depending on market).
• PDE5 inhibitor class competition and sequencing based on tolerability and response.

Does generic tadalafil reduce Adcirca revenue?

Yes, where generics and “authorized” tadalafil equivalents are substitutable through payer formularies and pharmacy benefit designs. Even without full therapeutic switching, a shift to generic tadalafil can reduce branded share, forcing price concessions or loss of formulary status.

When does Adcirca lose exclusivity and what are the key generic entry risks?

Adcirca’s branded exclusivity risk is tied to:

• Patent expiration for the branded tadalafil product in the US and other major markets.
• Regulatory exclusivity layers (if any) such as orphan or market exclusivity attached to specific indications.
• Paragraph IV and generic approval timing once ANDA timelines mature.

What does the exclusivity timeline look like in practice?

• The practical revenue inflection generally occurs in the window when first generic entries reach the market, followed by price erosion and share loss as payers standardize on lower-cost tadalafil products.
• Revenue typically stabilizes for a period if prescribers remain on brand, but payer pressure tends to accelerate erosion over subsequent quarters.

What is the Orange Book status of Adcirca and how many patents cover the product?

Orange Book listing structure matters for litigation and for generic launch barriers:

• Drug substance patents covering tadalafil.
• Drug product/formulation patents covering specific dosage forms, release behavior, or manufacturing approaches.
• Method-of-use patents tied to dosing regimens or PAH treatment.

Because Orange Book coverage can include multiple families and broad claim sets, the effective “number of meaningful barriers” is determined by which patents are:

• still active,
• listed as relevant to the approved use,
• and targeted by generic filings.

How strong is the patent estate for Adcirca and what claims tend to matter for generic challengers?

Generic challenge leverage usually focuses on:

• formulation and manufacturing claims that can be designed around,
• method-of-use claims where label design can avoid direct infringement (if permitted),
• and any blocking patents that cannot be avoided without product redesign or label carve-outs.

A strong estate typically means:

• multiple independently blocking patents,
• limited design-around freedom,
• and sustained enforcement history.

What patent litigation affects Adcirca and how do settlements impact launch timelines?

Where ANDA filings trigger Paragraph IV litigation, settlements often do one of three things:

• delay generic approval/launch through a negotiated “pay-for-delay” style agreement,
• permit an earlier launch in exchange for restrictions (label carve-outs, non-interference clauses),
• or set a date-based entry window with ongoing exclusivity carve-outs.

The financial effect is straightforward:

• settlements that push entry later typically preserve branded cash flows,
• earlier settlements compress the branded revenue runway.

What is the FDA regulatory status of Adcirca and how does pathway history affect competition?

Adcirca is an already-approved oral small molecule for PAH. Regulatory considerations affecting financial trajectory include:

• any label expansions that broaden addressable patient populations,
• any changes in dosing recommendations,
• and the extent to which label protection reduces generic substitutability.

Does label scope increase addressable market?

If PAH labeling has expanded or dosing has been revised in a way that supports broader use, adoption can improve. Financially, that raises volume and reduces the rate at which generics erode branded share.

How do product lifecycle events and patient adherence drive Adcirca revenue stability?

For oral chronic therapy in PAH, revenue stability depends on:

• persistence during titration and maintenance phases,
• tolerability driving continuation,
• and switching patterns after clinical follow-up.

What adherence metrics usually correlate with revenue?

• refill cadence and time-on-therapy,
• rate of discontinuation after dose adjustments,
• and payer switching events between brand and generic.

How does Adcirca compare with other PAH drugs on financial exposure to patent expiry and price erosion?

A PAH portfolio comparison typically shows:

• branded PDE5 inhibitors face substantial share compression once generic tadalafil is established,
• while some newer agents with longer patent horizons can retain price and volume longer,
• and combination regimens shift mix toward whichever agent is preferred by payer protocols.

In practical terms, if tadalafil generics are available while alternative PAH agents remain brand-only, Adcirca faces a more accelerated gross-to-net pressure cycle than therapies with later expiries.

What revenue exposure does Adcirca face from generic entry scenarios?

Generic entry scenarios typically create a pattern:

1. Initial generic approvals generate rapid loss of branded share in commercial channels.
2. Payer formulary consolidation shifts additional prescriptions to generics.
3. Price erosion and gross-to-net pressure lower net revenue even if volume holds.

How would a delayed entry versus rapid entry change financial trajectory?

• Delayed entry extends branded net revenue runway and reduces immediate cash flow volatility.
• Rapid entry increases quarter-to-quarter revenue variability and can force broader pricing concessions.

What commercial levers can sustain Adcirca profitability during competitive price erosion?

Branded manufacturers often respond with:

• payer contracting and rebates to defend preferred status,
• patient support programs that reduce switching friction,
• and targeted outreach to PAH prescribers for guideline-consistent use.

The strength of these levers declines once formularies fully standardize on generics.

Key Takeaways

• Adcirca’s financial trajectory is primarily driven by PAH demand persistence plus the intensity and timing of tadalafil-class substitution.
• The main revenue inflection typically aligns with generic tadalafil availability and subsequent payer formulary consolidation.
• Competitive pressure comes from both PAH class therapies and tadalafil substitution, making gross-to-net management as important as volume.
• The patent estate and Orange Book coverage determine how long branded cash flows stay protected from ANDA-driven entry timing risk.
• Litigation and settlements can materially shift launch windows, changing the slope of branded revenue erosion.

FAQs

1) How do gross-to-net dynamics typically change for branded oral PAH therapies after tadalafil generics launch?

2) What formulary design features most influence switching from Adcirca to generic tadalafil?

3) How do PAH guideline updates change the mix between PDE5 inhibitors and prostacyclin pathway therapies?

4) What label carve-outs or indications can reduce direct competition for generics versus branded tadalafil?

5) How does specialty pharmacy management affect Adcirca persistence and refill rates?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA: Adcirca (tadalafil). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm