TADALAFIL - Generic Drug Details

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What are the generic sources for tadalafil and what is the scope of freedom to operate?

Tadalafil is the generic ingredient in six branded drugs marketed by Cmp Dev Llc, B Better, Eli Lilly Co, Teva Pharms Inc, Teva Pharms Usa, Lilly, Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hangzhou Binjiang, Hetero Labs Ltd Iii, Hibrow Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Prinston Inc, Qilu Pharm Hainan, Rising, Shandong, Sun Pharm, Sunshine, Torrent, Umedica, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms, and is included in forty-six NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has nine patent family members in nine countries.

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

Summary for TADALAFIL

International Patents:	9
US Patents:	3
Tradenames:	6
Applicants:	33
NDAs:	46
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	214
Patent Applications:	6,577
Drug Prices:	Drug price trends for TADALAFIL
Drug Sales Revenues:	Drug sales revenues for TADALAFIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TADALAFIL
What excipients (inactive ingredients) are in TADALAFIL?	TADALAFIL excipients list
DailyMed Link:	TADALAFIL at DailyMed

See drug prices for TADALAFIL

See drug sales revenues for TADALAFIL

Recent Clinical Trials for TADALAFIL

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

Sponsor	Phase
VA Boston Healthcare System	Phase 2
VA Nebraska Western Iowa Health Care System	Phase 2
Atlanta VA Medical Center	Phase 2

See all TADALAFIL clinical trials

Pharmacology for TADALAFIL

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for TADALAFIL

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for TADALAFIL

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for TADALAFIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADCIRCA	Tablets	tadalafil	20 mg	022332	1	2009-10-15
CIALIS	Tablets	tadalafil	2.5 mg	021368	1	2008-10-14
CIALIS	Tablets	tadalafil	5 mg, 10 mg and 20 mg	021368	1	2007-11-21

US Patents and Regulatory Information for TADALAFIL

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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
Torrent	TADALAFIL	tadalafil	TABLET;ORAL	211839-003	Mar 26, 2019	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hangzhou Binjiang	TADALAFIL	tadalafil	TABLET;ORAL	208824-003	Oct 27, 2020	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	TADALAFIL	tadalafil	TABLET;ORAL	204809-003	Mar 26, 2019	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Umedica	TADALAFIL	tadalafil	TABLET;ORAL	211298-004	Oct 23, 2020	BX	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	⤷ Sign Up	⤷ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	⤷ Sign Up	⤷ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	⤷ Sign Up	⤷ Sign Up
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for TADALAFIL

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Limited	Talmanco (previously Tadalafil Generics)	tadalafil	EMEA/H/C/004297 Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.	Authorised	yes	no	no	2017-01-09
Eli Lilly Nederland B.V.	Tadalafil Lilly	tadalafil	EMEA/H/C/004666 Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Lilly is not indicated for use by women.Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.	Authorised	no	no	no	2017-03-22
Eli Lilly Nederland B.V.	Adcirca (previously Tadalafil Lilly)	tadalafil	EMEA/H/C/001021 AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.	Authorised	no	no	no	2008-10-01
Eli Lilly Nederland B.V.	Cialis	tadalafil	EMEA/H/C/000436 Treatment of erectile dysfunction.In order for tadalafil to be effective, sexual stimulation is required.Cialis is not indicated for use by women.	Authorised	no	no	no	2002-11-12
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for TADALAFIL

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Country	Patent Number	Title	Estimated Expiration
Singapore	11202006080S	LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS	⤷ Sign Up
Japan	2021509114	ＰＤＥＶ阻害剤のための液体経口処方物	⤷ Sign Up
Brazil	112020012986	formulações orais líquidas para inibidores de pde v	⤷ Sign Up
Canada	3086881	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TADALAFIL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	CA 2016 00024	Denmark	⤷ Sign Up	PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2101777	300813	Netherlands	⤷ Sign Up	PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668	SPC/GB03/007	United Kingdom	⤷ Sign Up	PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
0740668	PA2003001,C0740668	Lithuania	⤷ Sign Up	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

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