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Last Updated: February 20, 2020

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Tadalafil - Generic Drug Details

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What are the generic sources for tadalafil and what is the scope of patent protection?

Tadalafil is the generic ingredient in four branded drugs marketed by Eli Lilly Co, Teva Pharms Usa, Lilly, 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, Torrent, Unichem Labs Ltd, Watson Labs Inc, and Zydus Pharms, and is included in thirty-two NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has one hundred and one patent family members in forty-seven countries.

There are twenty-five drug master file entries for tadalafil. Forty suppliers are listed for this compound.

Drug Prices for tadalafil

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Drug Sales Revenue Trends for tadalafil

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Recent Clinical Trials for tadalafil

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SponsorPhase
Janssen Research & Development, LLCPhase 1
University of California, San DiegoPhase 2
University of British ColumbiaN/A

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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
2018-06-07
2017-07-12
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
Amneal Pharms Co TADALAFIL tadalafil TABLET;ORAL 209744-001 Mar 26, 2019 AB 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
Hetero Labs Ltd Iii TADALAFIL tadalafil TABLET;ORAL 209908-002 Mar 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB RX Yes No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii TADALAFIL tadalafil TABLET;ORAL 209908-003 Mar 26, 2019 AB 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

Expired US Patents for tadalafil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003   Start Trial   Start Trial
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tadalafil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 93081 Luxembourg   Start Trial PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
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 03C0017 France   Start Trial PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
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
2101777 122016000039 Germany   Start Trial PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
Medtronic
Express Scripts
Moodys

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.