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. Forty-eight 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:	6,652
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

Expired US Patents for ADCIRCA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	5,859,006*PED
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	7,182,958*PED
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	6,821,975*PED

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

International Patents for ADCIRCA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9609758
Poland	185999
Germany	60039357
Czech Republic	300151	Cásticová forma beta-karbolinového volného léciva, zpusob její výroby a použití a farmaceutická kompozice s jejím obsahem (Particulate form of beta-carboline free medicament, process for its preparation and use as well as pharmaceutical composition in which the particulate form is comprised)

Supplementary Protection Certificates for ADCIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2059246	122024000070	Germany		PRODUCT NAME: KOMBINATION AUS (A) MACITENTAN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON UND (B) TADALAFIL ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1859 20240927
0740668	CA 2003 00008	Denmark
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
2101777	CA 2016 00024	Denmark		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125

Market Dynamics and Financial Trajectory of ADCIRCA

Last updated: July 28, 2025

Introduction

ADCIRCA (tadalafil) has established a significant presence within the niche of treatment options for pulmonary arterial hypertension (PAH). Originally developed for erectile dysfunction and benign prostatic hyperplasia, tadalafil’s repositioning for PAH has shaped a distinct market trajectory. This analysis explores the current market dynamics influencing ADCIRCA’s financial future, encompassing competitive positioning, regulatory landscape, market adoption, and revenue projections.

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Market Overview and Product Profile

ADCIRCA (tadalafil), a phosphodiesterase type 5 (PDE5) inhibitor, received FDA approval in 2009 for the treatment of PAH, complementing its prior indications for erectile dysfunction. Its extended duration of action and proven efficacy positioned it as a key player in the oral PAH treatment landscape, alongside other PDE5 inhibitors such as sildenafil (Revatio) and newer agents like riociguat.

The drug’s unique pharmacokinetic profile—longer half-life and once-daily dosing—attracts both patients and prescribers, providing convenience and consistent drug exposure. As a generic drug in many markets, tadalafil has also benefited from cost advantages, improving access.

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Market Dynamics Affecting ADCIRCA

1. Competitive Landscape

The PAH market remains highly competitive, with multiple classes of agents vying for prescribing preferences. Sildenafil (Revatio) directly competes with ADCIRCA as a PDE5 inhibitor, often differing in patient and physician choice based on tolerability, dosing schedules, and insurance coverage. Meanwhile, newer classes like soluble guanylate cyclase stimulators (e.g., riociguat) and prostacyclin analogs occupy segments for more advanced or refractory PAH cases.

Generic availability significantly influences market share, with tadalafil's patent expiration reducing exclusivity. Although originator Pfizer’s patent rights in the U.S. expired in 2018, the branded ADCIRCA continues to retain brand recognition, especially in certain regions or specialized prescribing scenarios. Market fragmentation and increasing generic competition are expected to pressure pricing and margins.

2. Regulatory and Approval Dynamics

The regulatory environment shapes ADCIRCA’s market access. The FDA’s decision to approve tadalafil for PAH, along with approvals in other jurisdictions, has solidified its role. Yet, any regulatory hurdles regarding safety, label expansions, or new indications could impact financial outcomes.

Additionally, clinical trial data and evolving guidelines influence adoption trends. The inclusion of tadalafil in latest PAH management guidelines augments its credibility, yet the emergence of new classes may limit its growth potential.

3. Market Penetration and Adoption

Physician prescribing patterns are driven by clinical evidence, safety profile, and formulary coverage. ADCIRCA’s once-daily schedule, efficacy, and tolerability favor its adoption, especially in early-stage PAH. However, competition from other PDE5 inhibitors and emerging therapies exerts pressure.

Patient compliance benefits from the pharmacokinetic profile, bolstering long-term adherence and potentially driving sustained sales. Despite this, market penetration may plateau due to therapeutic overlaps and patient-specific factors.

4. Pricing Strategies and Reimbursement

Pricing remains critical. The availability of generic tadalafil has introduced significant price competition. Payers and insurers favor cost-effective options, often favoring generic versions over branded ADCIRCA, constraining profit margins.

Reimbursement policies in key markets like the U.S., Europe, and Japan play pivotal roles. Favorable reimbursement enhances market access, while restrictive policies could impede growth.

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Financial Trajectory and Revenue Projections

1. Historical Revenue Trends

Pfizer’s global revenues from ADCIRCA peaked early post-approval, driven by branded sales. Post-patent expiration, revenues declined as generic alternatives gained market share. The branded product still sustains a niche for treatment-resistant or specific patient groups, but overall sales are under pressure.

2. Forecasting Future Revenue

Recent estimates suggest that ADCIRCA’s global sales may stabilize at a lower plateau, with projections indicating modest annual declines due to generic competition. However, geographic expansion and formulary listing in new markets could offset some losses.

Assuming continued generic erosion, revenues could decline by approximately 5-10% annually over the next five years, unless new indications or formulations are introduced. Nonetheless, Pfizer’s strategic focus on niche PAH segments, along with ongoing market penetration in emerging markets, might provide some revenue resiliency.

3. Potential Growth Drivers

• New Indications: Expansion into additional pulmonary hypertension subtypes or combination therapy approvals could rejuvenate demand.
• Market Expansion: Increased accessibility in emerging markets, where generic adoption is gradual, offers revenue opportunities.
• Enhanced Patient Adherence: Improved formulations or fixed-dose combinations may improve adherence, indirectly bolstering sales.
• Strategic Partnerships and Licensing: Collaborations for co-marketing or distribution can expand geographic reach and accelerate revenue growth.

4. Risks to Financial Prospects

• Patent and Market Entry of Generics: Rapid generic entry erodes pricing and market share.
• Emergence of Alternative Therapies: The advent of more effective or targeted drugs could overshadow ADCIRCA.
• Pricing and Reimbursement Constraints: Payer pressures may limit accessible prices, affecting profitability.
• Regulatory Challenges: Any safety concerns or label restrictions could restrict marketability.

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Market Outlook and Strategic Implications

The future of ADCIRCA’s financial trajectory hinges on balancing competitive pressures with strategic innovation. Continued emphasis on niche markets, strategic partnerships, and potential new indications are pivotal. Pfizer and other stakeholders must monitor patent landscapes, optimize market access, and innovate delivery methods to sustain revenue streams.

Emerging markets provide substantial growth potential, given increasing disease prevalence and evolving healthcare infrastructure. However, in mature markets, the focus shifts toward cost-containment and value-based sourcing, emphasizing the importance of maintaining operational efficiency and competitive pricing.

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Key Takeaways

• Market Saturation and Competition: The advent of generics post-patent expiry significantly depresses ADCIRCA’s revenue potential but also broadens access.
• Pipeline and Indication Expansion: Growth prospects are linked to new approvals, combination therapies, and expanded indications, which could mitigate revenue declines.
• Pricing and Reimbursement Pressures: Cost containment strategies and formulary restrictions threaten profitability, emphasizing the need for strategic pricing.
• Geographical Diversification: Emerging markets present opportunities for revenue stabilization amid saturated developed markets.
• Strategic Focus: Partnering, innovative formulations, and demonstrating clinical value remain central to sustaining financial performance.

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FAQs

1. How has patent expiry impacted ADCIRCA’s market share?
Patent expiration in 2018 introduced generics, leading to a significant decline in branded sales due to price competition. While the brand retains recognition, its market share has diminished, with generics capturing the majority of prescriptions.

2. Are there new indications or formulations for ADCIRCA in development?
Currently, no major new indications or formulations are pending approval. Future development depends on clinical trial outcomes and strategic priorities to differentiate the drug in a competitive landscape.

3. How does ADCIRCA compare to its main competitors in the PAH market?
It competes primarily with sildenafil (Revatio) and other PGI2 analogs. ADCIRCA’s long-acting profile offers convenience advantages, but price competition with generics and emerging therapies limit its market dominance.

4. What geographic regions offer growth opportunities for ADCIRCA?
Emerging markets such as India, China, and Latin America present growth potential due to increasing healthcare access, rising disease awareness, and slower generic penetration.

5. What is the outlook for ADCIRCA’s revenues over the next five years?
Revenues are projected to decline gradually, influenced by generic competition and market saturation. Strategic expansion and potential new indications could stabilize or slightly boost revenues, but overall, a downward trend is anticipated without significant innovation or market expansion.

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References

1. Pfizer. (2009). FDA Approves Tadalafil for Pulmonary Arterial Hypertension. [Press Release]
2. IQVIA. (2022). Global Prescription Drug Market Data.
3. Regulatory filings and clinical trial registries.
4. Market intelligence reports from Evaluate Pharma and Pharma Intelligence.
5. Industry analyses from Bloomberg NEF and similar sources.