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Generated: August 20, 2018

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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. Nine suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

Drug patent expirations by year for CIALIS
Pharmacology for CIALIS
Medical Subject Heading (MeSH) Categories for CIALIS
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 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Paragraph IV (Patent) Challenges for CIALIS
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 2.5 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 5 mg, 10 mg and 20 mg ➤ Subscribe ➤ Sign Up

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
6,784,179 Tetracyclic derivatives, process of preparation and use ➤ Sign Up
6,451,807 Methods of treating sexual dysfunction in an individual suffering from a retinal disease, class 1 congestive heart failure, or myocardial infarction using a PDE5 inhibitor ➤ Sign Up
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors ➤ Sign Up
6,841,167 .beta.-carboline pharmaceutical compositions ➤ Sign Up
6,143,746 Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use ➤ Sign Up
6,127,542 Tetracyclic derivatives, process of preparation and use ➤ Sign Up
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for CIALIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0813 Netherlands ➤ Sign Up PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
2016000039 Germany ➤ Sign Up PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0740668/01 Switzerland ➤ Sign Up PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
2016 00024 Denmark ➤ Sign Up PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
081 Luxembourg ➤ Sign Up PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
017 Luxembourg ➤ Sign Up
C0017 France ➤ Sign Up PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Healthtrust
McKinsey
Colorcon
US Department of Justice
Merck
UBS
Julphar
QuintilesIMS

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