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:	108
Clinical Trials:	23
Patent Applications:	6,324
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
Vigonvita Life 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	6,821,975*PED
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	7,182,958*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/004297 Talmanco 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/004666 Treatment 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/001021 AdultsTreatment 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/000436 Treatment 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/003787 Treatment 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
China	1195290
Peru	04802001
Poland	353268
Czech Republic	286566	Tetracyklické deriváty, způsoby jejich výroby, jejich použití a farmaceutické prostředky s jejich obsahem (Tetracyclic derivatives, process of their preparation and pharmaceutical preparations containing thereof)
Singapore	49184	Tetracyclic derivatives process of preparing and use
Australia	702324

Supplementary Protection Certificates for ADCIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	CA 2016 00024	Denmark		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0740668	03C0017	France		PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
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	2016C/032	Belgium		PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
0740668	CA 2003 00008	Denmark

ADCIRCA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adcirca

Overview of Adcirca

Adcirca, also known as tadalafil, is a phosphodiesterase type 5 (PDE5) inhibitor used primarily for the treatment of pulmonary arterial hypertension (PAH). It was approved in major markets in 2009, following the first-to-market PDE5 inhibitor Revatio (sildenafil)[3].

Mechanism of Action

Adcirca works by inhibiting the PDE5 enzyme, which enhances the effect of nitric oxide (NO) by increasing cyclic guanosine monophosphate (cGMP) concentrations. This leads to smooth muscle cell vasorelaxation, improving blood flow and reducing pulmonary artery pressure[3].

Market Position

Historical Market Share

Adcirca has historically been a significant player in the PAH market, particularly after its approval in 2009. It was the second PDE5 inhibitor to enter the market and managed to surpass the sales of the first-to-market Revatio in some periods[3].

Impact of Generic Competition

However, the introduction of generic competition in the US and major EU markets since 2018 has significantly eroded Adcirca's sales. For instance, Adcirca's net product sales decreased by $96.0 million in 2018 compared to the previous year, largely due to generic competition[5].

Financial Performance

Revenue Trends

• In 2017, Adcirca saw a $6.6 million increase in net product sales, contributing to the overall revenue growth of United Therapeutics Corporation[2].
• However, by 2018, Adcirca's net product sales had decreased by $96.0 million, reflecting the impact of generic competition[5].

Quarterly and Annual Financials

• For the quarter ended December 31, 2018, Adcirca's sales decline was part of a broader revenue picture where United Therapeutics Corporation reported total revenues of $381.4 million, down from $464.7 million in the previous quarter[5].
• The annual financials for 2018 showed a similar trend, with Adcirca's sales contributing to a total revenue of $1,627.8 million, which was lower than the $1,725.3 million in 2017[5].

Market Dynamics

Competitive Landscape

The PAH market is highly competitive, with several drug classes vying for market share. The PDE5 inhibitor class, to which Adcirca belongs, has faced intense competition from generics. Additionally, other classes such as endothelin receptor antagonists (ERAs) and prostacyclins have gained prominence, further challenging Adcirca's market position[1][4].

Clinical Trials and Label Expansions

Despite the challenges, there is ongoing research to potentially expand the labels of existing drugs, including those in the PDE5 inhibitor class. For example, combination therapies involving PDE5 inhibitors and ERAs, as established by the AMBITION trial, continue to be a focus area. However, these efforts may not fully offset the losses due to generic competition[1][3].

Segment Analysis

By Drug Class

The prostacyclin and prostacyclin analogs segment has dominated the PAH market, accounting for around 47.0% of the revenue share in 2021. This segment's growth has been driven by high demand and expanding indications, which has further pressured the PDE5 inhibitor class[4].

By Type

The branded segment, which includes Adcirca, dominated the market with an 88.2% revenue share in 2021. However, the generics segment is expected to grow at a faster CAGR due to the expiry of key patents and the rising launch of generics[4].

Impact of External Factors

COVID-19 Pandemic

The COVID-19 pandemic had a significant impact on the PAH market, including operational challenges, supply chain bottlenecks, and challenges in conducting clinical trials. This led to a reduction in new patient starts and new patient prescriptions, further affecting Adcirca's sales[4].

Future Outlook

Market Size and Growth

The PAH market is projected to grow at a CAGR of 5.1% from 2022 to 2030, reaching a market size of around $10.9 billion by 2030. However, the PDE5 inhibitor class is expected to continue facing challenges from generic competition and the rising prominence of other drug classes[4].

Competitive Strategies

To maintain market relevance, companies may focus on combination therapies, label expansions, and innovative delivery methods. For instance, the approval of Uptravi for intravenous use in PAH patients in 2021 highlights the evolving treatment landscape[4].

Key Takeaways

• Adcirca, a PDE5 inhibitor, has faced significant generic competition since 2018, leading to a decline in sales.
• The PAH market is dominated by prostacyclins and ERAs, with the PDE5 inhibitor class under pressure.
• Combination therapies and label expansions are critical for maintaining market share.
• External factors like the COVID-19 pandemic have impacted market dynamics and patient treatment patterns.
• The PAH market is expected to grow, but the PDE5 inhibitor class must adapt to remain competitive.

FAQs

What is Adcirca used for?

Adcirca is used for the treatment of pulmonary arterial hypertension (PAH).

How does Adcirca work?

Adcirca works by inhibiting the PDE5 enzyme, enhancing the effect of nitric oxide and increasing cGMP concentrations, leading to smooth muscle cell vasorelaxation.

What has been the impact of generic competition on Adcirca?

Generic competition since 2018 has significantly eroded Adcirca's sales, with a notable decline in net product sales.

How has the COVID-19 pandemic affected the PAH market?

The pandemic has led to operational challenges, supply chain issues, and a reduction in new patient starts and prescriptions, affecting the overall market growth.

What is the projected growth of the PAH market?

The PAH market is expected to grow at a CAGR of 5.1% from 2022 to 2030, reaching a market size of around $10.9 billion by 2030.

Sources

1. Global Pulmonary Arterial Hypertension Market Report 2021 - Globenewswire
2. United Therapeutics Corporation Reports 2017 Fourth Quarter And Annual Financial Results - PR Newswire
3. Adcirca (tadalafil; Eli Lilly/United Therapeutics/Nippon Shinyaku) - Business Wire
4. Pulmonary Arterial Hypertension Market Size Worth Around USD 10.9 Bn By 2030 - Biospace
5. United Therapeutics Corporation Reports 2018 Fourth Quarter And Annual Financial Results - Biospace