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, Fourrts Labs, Hangzhou Binjiang, Hetero Labs Ltd Iii, 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-nine 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: | 49 |
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 |
Recent Clinical Trials for TADALAFIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
VA Eastern Colorado Health Care System | Phase 2 |
VA Boston Healthcare System | Phase 2 |
VA Nebraska Western Iowa Health Care System | Phase 2 |
Pharmacology for TADALAFIL
Drug Class | Phosphodiesterase 5 Inhibitor |
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for TADALAFIL
Anatomical Therapeutic Chemical (ATC) Classes for TADALAFIL
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hangzhou Binjiang | TADALAFIL | tadalafil | TABLET;ORAL | 208824-003 | Oct 27, 2020 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chartwell Rx | TADALAFIL | tadalafil | TABLET;ORAL | 210716-001 | Dec 29, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Unichem | TADALAFIL | tadalafil | TABLET;ORAL | 209250-003 | Mar 26, 2019 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ajanta Pharma Ltd | TADALAFIL | tadalafil | TABLET;ORAL | 209654-001 | Mar 26, 2019 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Accord Hlthcare | TADALAFIL | tadalafil | TABLET;ORAL | 209167-004 | Mar 26, 2019 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ajanta Pharma Ltd | TADALAFIL | tadalafil | TABLET;ORAL | 209654-002 | Mar 26, 2019 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | TADALAFIL | tadalafil | TABLET;ORAL | 206693-001 | Mar 26, 2019 | AB1 | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | 021368-004 | Jan 7, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332-001 | May 22, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-002 | 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
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 | |
Mylan Pharmaceuticals Limited | Tadalafil Mylan | tadalafil | EMEA/H/C/003787 Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Mylan is not indicated for use by women. |
Authorised | yes | no | no | 2014-11-21 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TADALAFIL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Singapore | 11202006080S | LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS | ⤷ Sign Up |
European Patent Office | 3731870 | FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) | ⤷ Sign Up |
Brazil | 112020012986 | formulações orais líquidas para inibidores de pde v | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2019130052 | ⤷ Sign Up | |
Japan | 2021509114 | PDE V阻害剤のための液体経口処方物 | ⤷ Sign Up |
Canada | 3086881 | FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) | ⤷ Sign Up |
China | 111683683 | PDE V抑制剂的液体口服制剂 (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TADALAFIL
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 |
0740668 | 03C0017 | France | ⤷ Sign Up | PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112 |
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 |
2101777 | 122016000039 | Germany | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120 |
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 | 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 |
2101777 | 2016C/032 | Belgium | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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