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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 four patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and twenty-four patent family members in sixty-two countries.

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

Summary for CIALIS

International Patents:	324
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	8
Bulk Api Vendors:	72
Clinical Trials:	30
Patent Applications:	3,336
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CIALIS
DailyMed Link:	CIALIS at DailyMed

Pharmacology for CIALIS

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for CIALIS

Phosphodiesterase 5 Inhibitors

Urological Agents

Vasodilator Agents

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

(2R,8R)-2-(2H-1,3-BENZODIOXOL-5-YL)-6-METHYL-3,6,17-TRIAZATETRACYCLO[8.7.0.0(3),?.0(1)(1),(1)?]HEPTADECA-1(10),11(16),12,14-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-methyl-pyrazino[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-METHYL-PYRAZINO[1',2':1,6]PYRIDOL[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,12aR)-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

(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

Acdirca

ADCIRCA

Adcirca (TN)

AK-60035

AKOS015892559

AN-15538

ANW-54093

BDBM14777

C-21522

CAS-171596-29-5

CC-25771

CC0257

CCG-100973

CHEBI:71940

CHEMBL779

Cialis (TN)

Cialis, GF 196960, IC 351, ICOS 351, Tadalafil

Cialis, Tadalafil

CPD000466321

CS-1414

CTK8B6705

D02008

D05MQK

DB00820

DR002249

DSSTox_CID_26786

DSSTox_GSID_46786

DSSTox_RID_81904

DTXSID9046786

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

Lilly brand of tadalafil

LS-186558

LS-187015

LS-187770

LY-450190

MFCD10465563

MLS000759426

MLS001165782

MLS001195644

MLS001424132

MLS006010126

MolPort-002-885-864

NC00223

NCGC00168781-01

NCGC00263909-02

NSC-750236

NSC-759172

NSC750236

NSC759172

Pharmakon1600-01505639

PL048252

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

SC-16083

SCHEMBL33333

SMR000466321

SR-05000001940

SR-05000001940-1

Tadalafil

Tadalafil (Cialis)

Tadalafil (JAN/USAN/INN)

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

Tardenafil|||Cialis

TILDENAFIL

Tox21_112642

Tox21_112642_1

UNII-742SXX0ICT

W-5349

WOXKDUGGOYFFRN-IIBYNOLFSA-N

X-3024

zalutia

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		RX	Yes	No
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003		RX	Yes	No
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003		RX	Yes	Yes
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003		RX	Yes	No

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Expired US Patents for CIALIS

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

Paragraph IV (Patent) Challenges for CIALIS

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	2.5 mg		2008-10-14
	Tablets	5 mg, 10 mg and 20 mg		2007-11-21

Non-Orange Book US Patents for CIALIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,608,065	Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction
6,127,542	Tetracyclic derivatives, process of preparation and use
5,981,527	Cyclic GMP-specific phosphodiesterase inhibitors
6,369,059	Tetracyclic derivatives, process of preparation and use

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International Patents for CIALIS

Country	Document Number	Estimated Expiration
Peru	00712001
Australia	4491200
World Intellectual Property Organization (WIPO)	9703985
New Zealand	504163

Supplementary Protection Certificates for CIALIS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2003001	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
C0017	France		PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
2003 00008	Denmark
2016 00024	Denmark		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125