ADCIRCA Drug Patent Profile

When do Adcirca patents expire, 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:	6,425
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for ADCIRCA

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

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
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009

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
European Patent Office	1200092	PRODUITS DE MEDICAMENTS A BASE DE BETA-CARBOLINE (BETA-CARBOLINE DRUG PRODUCTS)
Australia	704955
European Patent Office	2036560
United Kingdom	9514474
Argentina	033953	UNA FORMA DE DROGA LIBRE EN PARTICULAS DE UN COMPUESTO DE BETA-CARBOLINA , SU COMPOSICION FARMACEUTICA, METODO DE TRATAMIENTO DE LA DISFUNCION SEXUAL , METODO PARA FABRICAR DICHA FORMA DEL COMPUESTO Y USO DE LAS PARTICULAS
Hungary	228369	USE OF CGMP-PHOSPHODIESTERASE INHIBITORS TO TREAT IMPOTENCE
Peru	04802001

Supplementary Protection Certificates for ADCIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	122016000039	Germany		PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
2101777	CA 2016 00024	Denmark		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
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	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	300124	Netherlands		300124, 20150119, EXPIRES: 20171111
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0740668	C00740668/01	Switzerland		PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004