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INTELENCE Drug Profile
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Which patents cover Intelence, and what generic alternatives are available?
Intelence is a drug marketed by Janssen R And D and is included in one NDA. There are three patents protecting this drug.
This drug has fifty-eight patent family members in thirty-five countries.
The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the etravirine profile page.
US ANDA Litigation and Generic Entry Outlook for Intelence
Intelence was eligible for patent challenges on January 18, 2012.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 16, 2021. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for INTELENCE
| International Patents: | 58 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 105 |
| Clinical Trials: | 13 |
| Patent Applications: | 1,615 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for INTELENCE |
| DailyMed Link: | INTELENCE at DailyMed |
Generic Entry Opportunity Date for INTELENCE
Generic Entry Date for INTELENCE*:
Constraining patent/regulatory exclusivity:
FDA exclusivity NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for INTELENCE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Rome Tor Vergata | Phase 2 |
| IRCCS Eugenio Medea | Phase 2 |
| Fundacio Lluita Contra la SIDA | 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 | Start Trial | Start Trial | Start Trial | ||||
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 INTELENCE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | Start Trial | Start Trial |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | Start Trial | Start Trial |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | Start Trial | Start Trial |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-002 | Dec 22, 2010 | Start Trial | Start Trial |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-003 | Mar 26, 2012 | Start Trial | Start Trial |
| Janssen R And D | INTELENCE | etravirine | TABLET;ORAL | 022187-001 | Jan 18, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INTELENCE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 004501 | Start Trial |
| Hong Kong | 1025330 | Start Trial |
| Hungary | 0104177 | Start Trial |
| Germany | 60025837 | Start Trial |
| Japan | 3635238 | Start Trial |
| South Korea | 20070036805 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INTELENCE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1002795 | 337 | Finland | Start Trial | |
| 1002795 | SPC/GB09/003 | United Kingdom | Start Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/003 GRANTED TO JANSSEN PHARMACEUTICA NV IN RESPECT OF THE PRODUCT ETRAVIRINE OPTIONALLY IN A FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6342 DATED 08 DECEMBER 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 AUGUST 2023. |
| 1002795 | 300373 | Netherlands | Start Trial | 300373, 20191101, EXPIRES: 20230827 |
| 1002795 | SZ 5/2009 | Austria | Start Trial | PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE |
| 1002795 | 09C0004 | France | Start Trial | 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 | CA 2009 00004 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
