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Last Updated: January 19, 2020

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TADALAFIL Drug Profile

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When do Tadalafil patents expire, and when can generic versions of Tadalafil launch?

Tadalafil is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mylan, Qilu, Sun Pharm, Sunshine Lake, Teva Pharms Usa, Torrent, Unichem Labs Ltd, Watson Labs Inc, and Zydus Pharms. and is included in twenty-nine NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Tadalafil

  Start Trial

A generic version of TADALAFIL was approved as tadalafil by TEVA PHARMS USA on January 19th, 2020.

Drug patent expirations by year for TADALAFIL
Drug Prices for TADALAFIL

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Drug Sales Revenue Trends for TADALAFIL

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Recent Clinical Trials for TADALAFIL

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

SponsorPhase
University of British ColumbiaN/A
University of California, San DiegoPhase 2
WorldCare ClinicalPhase 3

See all TADALAFIL clinical trials

Recent Litigation for TADALAFIL

Identify potential future generic entrants

District Court Litigation
Case NameDate
ELI LILLY AND COMPANY v. UMEDICA LABORATORIES PVT., LTD.2018-08-02
ELI LILLY AND COMPANY v. TORRENT PHARMACEUTICALS LIMITED2018-07-11
ELI LILLY AND COMPANY v. AMNEAL PHARMACEUTICALS LLC2018-05-10

See all TADALAFIL litigation

PTAB Litigation
PetitionerDate
Aquestive Therapeutics, Inc.2018-06-07
Argentum Pharmaceuticals LLC2017-07-12
Dr. Reddy's Laboratories, Inc.2017-07-10

See all TADALAFIL litigation

Pharmacology for TADALAFIL
Medical Subject Heading (MeSH) Categories for TADALAFIL
Synonyms for TADALAFIL
(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
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 (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
Paragraph IV (Patent) Challenges for TADALAFIL
Tradename Dosage Ingredient NDA Submissiondate
ADCIRCA TABLET;ORAL tadalafil 022332 2009-10-15
CIALIS TABLET;ORAL tadalafil 021368 2008-10-14
CIALIS TABLET;ORAL tadalafil 021368 2007-11-21

US Patents and Regulatory Information for TADALAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent TADALAFIL tadalafil TABLET;ORAL 212062-001 Mar 26, 2019 AB2 RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd TADALAFIL tadalafil TABLET;ORAL 210572-001 Feb 5, 2019 AB2 RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii TADALAFIL tadalafil TABLET;ORAL 209908-001 Mar 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan TADALAFIL tadalafil TABLET;ORAL 206956-002 Apr 29, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sunshine Lake TADALAFIL tadalafil TABLET;ORAL 211335-001 Mar 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd TADALAFIL tadalafil TABLET;ORAL 207244-004 Oct 7, 2019 AB1 RX No No   Start Trial   Start Trial   Start Trial
Mylan TADALAFIL tadalafil TABLET;ORAL 200630-001 Aug 3, 2018 AB2 RX No No   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

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