ADCIRCA Drug Patent Profile
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Which patents cover Adcirca, and what generic alternatives are available?
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.
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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: | 6,324 |
| 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 |
|---|---|
| The Curtis L. Brown Glioblastoma Research Fund | Phase 1 |
| Washington University School of Medicine | 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 |
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 | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332-001 | May 22, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Eli Lilly Co | ADCIRCA | tadalafil | TABLET;ORAL | 022332-001 | May 22, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Colombia | 5200849 | PRODUCTOS FARMACEUTICOS CON B - CARBOLINA | ⤷ Sign Up |
| Japan | 4347125 | ⤷ Sign Up | |
| Australia | 4491200 | ⤷ Sign Up | |
| Slovakia | 3998 | USE OF CGMP-PHOSPHODIESTERASE INHIBITORS TO TREAT IMPOTENCE | ⤷ Sign Up |
| Canada | 2226761 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADCIRCA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0740668 | CA 2003 00008 | Denmark | ⤷ Sign Up | |
| 2101777 | 300813 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125 |
| 2101777 | 93081 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125 |
| 2101777 | 122016000039 | Germany | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120 |
| 0740668 | PA2003001 | 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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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.
ISSN: 2162-2639
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