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CIALIS Drug Profile

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When do Cialis patents expire, and when can generic versions of Cialis launch?

Cialis is a drug marketed by Lilly and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and forty-three patent family members in forty-eight countries.

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

Summary for CIALIS

International Patents:	143
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	6
Bulk Api Vendors:	79
Clinical Trials:	33
Patent Applications:	3,600
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CIALIS
Drug Sales Revenues:	Drug sales revenues for CIALIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CIALIS
DailyMed Link:	CIALIS at DailyMed

See drug prices for CIALIS

See drug sales revenues for CIALIS

Recent Clinical Trials for CIALIS

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

Sponsor	Phase
University of California, San Diego	Phase 2
Imperial College London	Phase 3
Bristol-Myers Squibb	Early Phase 1

See all CIALIS clinical trials

Recent Litigation for CIALIS

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ELI LILLY AND COMPANY v. UMEDICA LABORATORIES PVT., LTD.	2018-08-02
ELI LILLY AND COMPANY v. TORRENT PHARMACEUTICALS LIMITED	2018-07-11
ELI LILLY AND COMPANY v. AMNEAL PHARMACEUTICALS LLC	2018-05-10

See all CIALIS litigation

PTAB Litigation

Petitioner	Date
Aquestive Therapeutics, Inc.	2018-06-07
Argentum Pharmaceuticals LLC	2017-07-12
Dr. Reddy's Laboratories, Inc.	2017-07-10

See all CIALIS litigation

Pharmacology for CIALIS

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Synonyms for CIALIS

(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

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 (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 CIALIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008	AB	RX	Yes	No					Y
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	AB	RX	Yes	No
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008	AB	RX	Yes	No
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	AB1	RX	Yes	Yes					Y
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	AB	RX	Yes	No					Y
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	AB1	RX	Yes	Yes

Expired US Patents for CIALIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008

Paragraph IV (Patent) Challenges for CIALIS

Drugname	Dosage	Strength	RLD	Date
	Tablets	2.5 mg
	Tablets	5 mg, 10 mg and 20 mg

International Patents for CIALIS

Country	Patent Number	Estimated Expiration
El Salvador	2002000055
New Zealand	521869
France	2795646
Sweden	0001518
Cyprus	1114651
European Patent Office	1173181

Supplementary Protection Certificates for CIALIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2101777	2016C/032	Belgium		PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
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	C00740668/01	Switzerland		PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
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