Tadalafil - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for tadalafil and what is the scope of patent protection?
Tadalafil
is the generic ingredient in five branded drugs marketed by Cmp Dev Llc, Eli Lilly Co, Teva Pharms Inc, Teva Pharms Usa, Lilly, Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Austarpharma, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mylan, 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-four NDAs. There are two 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-seven suppliers are listed for this compound.
Summary for tadalafil
International Patents: | 9 |
US Patents: | 2 |
Tradenames: | 5 |
Applicants: | 31 |
NDAs: | 44 |
Drug Master File Entries: | 25 |
Finished Product Suppliers / Packagers: | 47 |
Raw Ingredient (Bulk) Api Vendors: | 108 |
Clinical Trials: | 212 |
Patent Applications: | 6,699 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Assistance Publique - Hôpitaux de Paris | Phase 3 |
Benha University | N/A |
University of Arizona | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cipla | TADALAFIL | tadalafil | TABLET;ORAL | 210255-001 | Feb 5, 2019 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Alembic | TADALAFIL | tadalafil | TABLET;ORAL | 204809-004 | Mar 26, 2019 | AB1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ajanta Pharma Ltd | TADALAFIL | tadalafil | TABLET;ORAL | 210392-001 | Feb 5, 2019 | AB2 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | 021368-003 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-004 | Jan 7, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for tadalafil
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3731870 | FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) | ⤷ Try a Trial |
China | 111683683 | PDE V抑制剂的液体口服制剂 (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) | ⤷ Try a Trial |
Japan | 2021509114 | PDE V阻害剤のための液体経口処方物 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tadalafil
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0740668 | 03C0017 | France | ⤷ Try a Trial | PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112 |
0740668 | C00740668/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004 |
2101777 | 2016C/032 | Belgium | ⤷ Try a Trial | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.