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Generated: March 26, 2019

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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-five patent family members in sixty-two countries.

The generic ingredient in CIALIS is tadalafil. There are twenty-five drug master file entries for this compound. Thirteen 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
(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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 AB1 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 021368-004 Jan 7, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
➤ Subscribe Tablets 5 mg, 10 mg and 20 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for CIALIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0740668 C00740668/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
0740668 SPC004/2003 Ireland ➤ Try a Free Trial SPC004/2003, 20040610, EXPIRES: 20171111
2101777 122016000039 Germany ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0740668 03C0017 France ➤ Try a Free Trial PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
2101777 300813 Netherlands ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668 300124 Netherlands ➤ Try a Free Trial 300124, 20150119, EXPIRES: 20171111
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Fish and Richardson
Harvard Business School
Covington
Farmers Insurance

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