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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.

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

US ANDA Litigation and Generic Entry Outlook for Adcirca

A generic version of ADCIRCA was approved as tadalafil by TEVA PHARMS USA on May 22^nd, 2018.

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Summary for ADCIRCA

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	83
Clinical Trials:	7
Patent Applications:	4,118
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ADCIRCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADCIRCA
DailyMed Link:	ADCIRCA at DailyMed

Drug patent expirations by year for ADCIRCA

Recent Clinical Trials for ADCIRCA

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

Sponsor	Phase
Janssen Research & Development, LLC	Phase 1
Gilead Sciences	Phase 4
Ochsner Health System	Phase 4

See all ADCIRCA clinical trials

Recent Litigation for ADCIRCA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ERFINDERGEMEINSCHAFT UROPEP GbR v. Eli Lilly and Company	2015-07-01
Vanderbilt University v. ICOS Corporation	2005-07-20

See all ADCIRCA litigation

PTAB Litigation

Petitioner	Date
	2015-01-13

See all ADCIRCA litigation

Pharmacology for ADCIRCA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

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),11,13,15-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
(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-(2H-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-(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
171488-03-2
171596-29-5
1xoz
596T295
6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[2',1':6,1]pyrido[3,4-b]indole-1,4-dione
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
Adcirca (TN)
AK-60035
AKOS015892559
ANW-54093
AR-270/43507798
BDBM14777
BRD-K93645900-001-04-8
C-21522
CAS-171596-29-5
CC-25771
CC0257
CCG-100973
CHEBI:71940
CHEMBL779
Cialis
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
KS-1117
LS-186558
LS-187015
LS-187770
LY-450190
MLS000759426
MLS001165782
MLS001195644
MLS001424132
MLS006010126
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)-
Q424156
rel-(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
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 100 microg/mL in Methanol
Tadalafil Lilly
Tadalafil solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Tadalafil(Cialis)
Tadalafil(Cialis)/
Tadanafil
Taldalafil
Tardenafil\|\|\|Cialis
TILDENAFIL
Tox21_112642
Tox21_112642_1
UNII-742SXX0ICT
W-5349
WOXKDUGGOYFFRN-IIBYNOLFSA-N
X-3024
Zalutia (TN)
ZINC3993855

Paragraph IV (Patent) Challenges for ADCIRCA

Tradename	Dosage	Ingredient	NDA	Submissiondate
ADCIRCA	TABLET;ORAL	tadalafil	022332	2009-10-15

US Patents and Regulatory Information for ADCIRCA

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Glossary

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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	AB2	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ADCIRCA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ADCIRCA

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Country	Patent Number	Estimated Expiration
European Patent Office	1200091	Start Trial
Czech Republic	2002387	Start Trial
Bulgaria	100727	Start Trial
European Patent Office	1200090	Start Trial
Czech Republic	289686	Start Trial
Australia	6419296	Start Trial
Ukraine	71629	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ADCIRCA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	300813	Netherlands	Start Trial	PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668	PA2003001	Lithuania	Start 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	SPC004/2003	Ireland	Start Trial	SPC004/2003, 20040610, EXPIRES: 20171111
0740668	C00740668/01	Switzerland	Start Trial	PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
0740668	SPC/GB03/007	United Kingdom	Start Trial	PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
0740668	300124	Netherlands	Start Trial	300124, 20150119, EXPIRES: 20171111
0740668	PA2003001,C0740668	Lithuania	Start 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description