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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Medtronic
QuintilesIMS
US Army
Express Scripts
Chinese Patent Office
Healthtrust
Colorcon
Farmers Insurance

Generated: May 23, 2018

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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 three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ADCIRCA 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.
Drug patent expirations by year for ADCIRCA
Pharmacology for ADCIRCA
Medical Subject Heading (MeSH) Categories for ADCIRCA
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
(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 (TN)
AK-60035
AKOS015892559
AN-15538
ANW-54093
BDBM14777
C-21522
CAS-171596-29-5
CC-25771
CC0257
CCG-100973
CHEBI:71940
CHEMBL779
Cialis
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 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 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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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Paragraph IV (Patent) Challenges for ADCIRCA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 20 mg ➤ Subscribe 2009-10-15

Non-Orange Book US Patents for ADCIRCA

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 ➤ Try a Free Trial
6,127,542 Tetracyclic derivatives, process of preparation and use ➤ Try a Free Trial
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors ➤ Try a Free Trial
6,369,059 Tetracyclic derivatives, process of preparation and use ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ADCIRCA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
081 Luxembourg ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2003001 Lithuania ➤ Try a Free Trial 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
0740668/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
017 Luxembourg ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
McKesson
Medtronic
Fish and Richardson
Chubb
Johnson and Johnson
US Department of Justice
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.