INTELENCE Drug Patent Profile
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When do Intelence patents expire, and what generic alternatives are available?
Intelence is a drug marketed by Janssen R And D and is included in one NDA.
The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the etravirine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Intelence
A generic version of INTELENCE was approved as etravirine by AMNEAL on June 14th, 2021.
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Summary for INTELENCE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 14 |
| Patent Applications: | 4,021 |
| Drug Prices: | Drug price information for INTELENCE |
| What excipients (inactive ingredients) are in INTELENCE? | INTELENCE excipients list |
| DailyMed Link: | INTELENCE at DailyMed |
Recent Clinical Trials for INTELENCE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| IRCCS Eugenio Medea | Phase 2 |
| University of Rome Tor Vergata | Phase 2 |
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Phase 1 |
Pharmacology for INTELENCE
US Patents and Regulatory Information for INTELENCE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | AB | 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 INTELENCE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for INTELENCE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International NV | Intelence | etravirine | EMEA/H/C/000900 Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients. |
Authorised | no | no | no | 2008-08-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for INTELENCE
See the table below for patents covering INTELENCE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 301367 | Derivát pyrimidinu, zpusob a meziprodukty pro jeho prípravu a lécivo pro lécení HIV na jeho bázi (Pyrimidine derivative, process and intermediates for its preparation and medicament based thereon and intended for treating HIV) | ⤷ Sign Up |
| South Africa | 200103769 | HIV Replication inhibiting pyrimidines. | ⤷ Sign Up |
| Hungary | 0203568 | ⤷ Sign Up | |
| Germany | 69941934 | ⤷ Sign Up | |
| Czech Republic | 20011533 | ⤷ Sign Up | |
| Australia | 764472 | ⤷ Sign Up | |
| Hong Kong | 1038232 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INTELENCE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1002795 | CA 2009 00004 | Denmark | ⤷ Sign Up | |
| 1002795 | SPC033/2008 | Ireland | ⤷ Sign Up | SPC033/2008: 20090914, EXPIRES: 20230827 |
| 1002795 | 300373 | Netherlands | ⤷ Sign Up | 300373, 20191101, EXPIRES: 20230827 |
| 1002795 | 09C0004 | France | ⤷ Sign Up | PRODUCT NAME: ETRAVIRINE AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/08/468/001 DU 20080828; REGISTRATION NO/DATE AT EEC: EU/1/08/468/001 DU 20080828 |
| 1002795 | C01002795/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008 |
| 1002795 | SZ 5/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE |
| 1002795 | 91528 | Luxembourg | ⤷ Sign Up | 91528, EXPIRES: 20230828 |
| >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.
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