EDURANT Drug Patent Profile
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Which patents cover Edurant, and what generic alternatives are available?
Edurant is a drug marketed by Janssen Prods and is included in two NDAs. There are three patents protecting this drug.
This drug has one hundred and ninety-nine patent family members in forty-two countries.
The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Edurant
Edurant was eligible for patent challenges on May 20, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 21, 2025. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Summary for EDURANT
| International Patents: | 199 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 122 |
| Clinical Trials: | 14 |
| Patent Applications: | 1,146 |
| Drug Prices: | Drug price information for EDURANT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EDURANT |
| What excipients (inactive ingredients) are in EDURANT? | EDURANT excipients list |
| DailyMed Link: | EDURANT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EDURANT
*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 EDURANT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aptorum International Limited | Phase 1 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1/Phase 2 |
| ViiV Healthcare | Phase 1/Phase 2 |
Pharmacology for EDURANT
US Patents and Regulatory Information for EDURANT
EDURANT is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EDURANT is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting EDURANT
HIV inhibiting pyrimidines derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 EDURANT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EDURANT
See the table below for patents covering EDURANT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovenia | 1419152 | ⤷ Sign Up | |
| Singapore | 155885 | FURAMATE OF 4-((4-((4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL)AMINO)-2- PYRIMIDINYL)AMINO)BENZONITRILE | ⤷ Sign Up |
| European Patent Office | 1632232 | Sel de 4-[[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyl]amino]-2-Pyrimidinyl]amino]benzonitrile (Salt of 4[[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyl]amino]-2-Pyrimidinyl]amino]benzonitrile) | ⤷ Sign Up |
| Croatia | P20040096 | HIV INHIBITING PYRIMIDINES DERIVATIVES | ⤷ Sign Up |
| Luxembourg | 92008 | ⤷ Sign Up | |
| Poland | 1663240 | ⤷ Sign Up | |
| Norway | 340654 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EDURANT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663240 | 375 5032-2016 | Slovakia | ⤷ Sign Up | PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/EMTRICITABIN/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
| 1663240 | CA 2016 00063 | Denmark | ⤷ Sign Up | PRODUCT NAME: RILPIVIRIN ELLER TERAPEUTISK AEKVIVALENT FORM DERAF BESKYTTET AF GRUNDPATENTET SASOM ET FARMACEUTISK ACCEPTABELT SALT FX HYDROCHLORIDSALTET AF RILPIVIRIN OG TENOFOVIRALAFENAMID ELLER FARMACEUTISK ACCEPTABELT SALT DERAF FX TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 |
| 1419152 | C 2012 015 | Romania | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINA SI TOATE FORMELE ECHIVALENTE TERAPEUTIC ALEACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA RILPIVIRINEI CU ACIDULCLORHIDRIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/736/001; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/736/001; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
| 1663240 | CA 2016 00064 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 |
| 1419152 | CR 2012 00019 | Denmark | ⤷ Sign Up | PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128 |
| 1663240 | 122015000087 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 3808743 | C20220027 00378 | Estonia | ⤷ Sign Up | PRODUCT NAME: EMTRITSITABIIN/ RILPIVIRIIN;REG NO/DATE: EU/1/11/737 28.11.2011 |
| >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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