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ADCIRCA Drug Profile

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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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-three patent family members in thirty-four countries.

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

Summary for ADCIRCA

International Patents:	83
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	78
Clinical Trials:	5
Patent Applications:	3,469
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ADCIRCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADCIRCA
Prior Art and Litigation Support	Order Prior Art and Litigation support for ADCIRCA
DailyMed Link:	ADCIRCA at DailyMed

Pharmacology for ADCIRCA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for ADCIRCA

Phosphodiesterase 5 Inhibitors

Urological Agents

Vasodilator Agents

Synonyms for ADCIRCA

(2R,8R)-2-(1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0^{3,8}.0^{11,16}]heptadeca-1(10),11,13,15-tetraene-4,7-dione

(2R,8R)-2-(2H-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0^{3,8}.0^{11,16}]heptadeca-1(10),11(16),12,14-tetraene-4,7-dione

(2R,8R)-2-(2H-1,3-benzodioxol-5-yl)-6-methyl-3,6,17-triazatetracyclo[8.7.0.0;{3,8}.0;{11,16}]heptadeca-1(10),11,13,15-tetraene-4,7-dione

(6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

(6R,12 aR)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

(6R,12aR) 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino [1',2':1,6] pyrido[3,4-b]indole-1,4-dione

(6R,12aR) 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-(methylenedioxy)phenyl) pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione

(6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1,2,1,6]pyrido[3,4-b]indole-1,4-dione

(6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

(6R,12aR)-6-(Benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,12,12a-tetrahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4(6H,7H)-dione

(6R,12aR)-6-(benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

(6R,3,6,7,12,12a-Hexahydro-2-methyl-6-[3,4-(methylenedioxy)phenyl]pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

1,3-benzodioxol-5-yl(methyl)[?]dione

171596-29-5

1xoz

596T295

6-BENZO[1,3]DIOXOL-5-YL-2-METHYL-2,3,6,7,12,12A-HEXAHYDRO-PYRAZINO[1',2':1,6]PYRIDO[3,4-B]INDOLE-1,4-DIONE

742SXX0ICT

A23556

AB0008473

AB00639969_09

AB00639969_10

AB00639969-08

AB1009208

AB42193

ABP000527

AC1L380B

Adcirca (TN)

AK-60035

AKOS015892559

AN-15538

ANW-54093

BDBM14777

BRD-K93645900-001-04-8

C-21522

CAS-171596-29-5

CC-25771

CC0257

CCG-100973

CHEBI:71940

CHEMBL779

Cialis

Cialis (TN)

Cialis, Tadalafil

CPD000466321

CS-1414

CTK8B6705

D02008

DB00820

DSSTox_CID_26786

DSSTox_GSID_46786

DSSTox_RID_81904

DTXSID9046786

EX-A2644

FT-0080116

FT-0601538

FT-0674791

GF 196960

GF-196960

GF196960

GTPL7299

HMS2051N17

HMS2235L21

HSDB 7303

HY-90009A

IC 351

IC-351

Ic351

ICOS 351

J90025

KB-60666

KS-1117

LS-186558

LS-187015

LS-187770

LY-450190

MLS000759426

MLS001165782

MLS001195644

MLS001424132

MLS006010126

MolPort-002-885-864

NC00223

NCGC00168781-01

NCGC00263909-02

NSC-750236

NSC-759172

NSC750236

NSC759172

Pharmakon1600-01505639

PYR280

Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R-trans)-

Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-

Pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-

Pyrazino[1',6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12ahexahydro-2-methyl-, (6R,12aR)-

RTR-007551

s1512

SAM001246586

SB17348

SC-16083

SCHEMBL33333

SMR000466321

SR-05000001940

SR-05000001940-1

SW197603-2

Tadalafil

Tadalafil (Cialis)

Tadalafil (JAN/USAN/INN)

Tadalafil [USAN:INN:BAN]

Tadalafil [USAN]

Tadalafil 1.0 mg/ml in Acetonitrile

Tadalafil Lilly

Tadalafil solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material

Tadalafil(Cialis)

Tadalafil(Cialis)/

Tadanafil

Tardenafil|||Cialis

TILDENAFIL

Tox21_112642

Tox21_112642_1

UNII-742SXX0ICT

W-5349

WOXKDUGGOYFFRN-IIBYNOLFSA-N

X-3024

Zalutia (TN)

ZINC3993855

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					Y
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	AB2	RX	Yes	Yes					Y

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

Paragraph IV (Patent) Challenges for ADCIRCA

Drugname	Dosage	Strength	RLD	Date
	Tablets	20 mg

International Patents for ADCIRCA

Country	Patent Number	Estimated Expiration
Australia	4490900
Ukraine	71629
South Africa	200200825
China	1365282
Czech Republic	20020387

Supplementary Protection Certificates for ADCIRCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	122016000039	Germany		PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0740668	03C0017	France		PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112