ADCIRCA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Adcirca, and when can generic versions of Adcirca launch?
Adcirca is a drug marketed by Eli Lilly Co and is included in one NDA.
The generic ingredient in ADCIRCA is tadalafil. There are twenty-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Adcirca
A generic version of ADCIRCA was approved as tadalafil by TEVA PHARMS USA on May 22nd, 2018.
Summary for ADCIRCA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 108 |
Clinical Trials: | 23 |
Patent Applications: | 6,425 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ADCIRCA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADCIRCA |
What excipients (inactive ingredients) are in ADCIRCA? | ADCIRCA excipients list |
DailyMed Link: | ADCIRCA at DailyMed |
Recent Clinical Trials for ADCIRCA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Washington University School of Medicine | Phase 1 |
The Curtis L. Brown Glioblastoma Research Fund | Phase 1 |
Shanghai Institute of Materia Medica, Chinese Academy of Sciences | Phase 2 |
Pharmacology for ADCIRCA
Drug Class | Phosphodiesterase 5 Inhibitor |
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ADCIRCA
US Patents and Regulatory Information for ADCIRCA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332-001 | May 22, 2009 | AB2 | RX | Yes | Yes | ⤷ 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 ADCIRCA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332-001 | May 22, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332-001 | May 22, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332-001 | May 22, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ADCIRCA
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 ADCIRCA
See the table below for patents covering ADCIRCA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4150818 | ⤷ Try a Trial | |
Peru | 49495 | DERIVADO TETRACICLICO Y PROCESO PARA SU PREPARACION | ⤷ Try a Trial |
Spain | 2122543 | ⤷ Try a Trial | |
Czech Republic | 9800032 | ⤷ Try a Trial | |
Israel | 122870 | PHARMACEUTICAL COMPOSITIONS CONTAINING 6-ARYL-2,3,6,7,12,12a-HEXAHYDROPYRAZINO [2'1':'6,1] PYRIDO [3,4-b] INDOLE-1,4-DIONE DERIVATIVES FOR TREATMENT OF MALE ERECTILE DYSFUNCTION | ⤷ Try a Trial |
Norway | 20020532 | ⤷ Try a Trial | |
Norway | 20020531 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADCIRCA
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 | CA 2003 00008 | Denmark | ⤷ Try a Trial | |
0740668 | PA2003001 | Lithuania | ⤷ Try a Trial | 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 |
0740668 | 300124 | Netherlands | ⤷ Try a Trial | 300124, 20150119, EXPIRES: 20171111 |
0740668 | SPC004/2003 | Ireland | ⤷ Try a Trial | SPC004/2003, 20040610, EXPIRES: 20171111 |
0740668 | C00740668/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004 |
0740668 | PA2003001,C0740668 | Lithuania | ⤷ Try a Trial | 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 |