EDURANT Drug Patent Profile
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When do Edurant patents expire, and when can generic versions of Edurant launch?
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
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 |
| Formulation / Manufacturing: | see details |
| 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
Anatomical Therapeutic Chemical (ATC) Classes 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 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | RX | Yes | Yes | ⤷ 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 |
|---|---|---|---|
| Eurasian Patent Organization | 013686 | ГИДРОХЛОРИД 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL] AMINO]BENZONITRILE) | ⤷ Sign Up |
| Hungary | 0401346 | HIV-gátló pirimidinszármazékok, eljárás az előállításukra és ezeket tartalmazó gyógyszerkészítmények (HIV INHIBITING PYRIMIDINES DERIVATIVES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM) | ⤷ Sign Up |
| Eurasian Patent Organization | 200700534 | ФУМАРАТ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА | ⤷ Sign Up |
| Canada | 2398887 | 2,4,DI-(HETERO-) ARYLAMINO (-OXY)-5 PYRIMIDINES SUBSTITUTEESUTILISEES COMME AGENTS ANTINEOPLASIQUES (2,4,DI(HETERO-)ARYLAMINO(-OXY)-5-SUBSTITUTED PYRIMIDINES AS ANTINEOPLASTIC AGENTS) | ⤷ Sign Up |
| Norway | 20071720 | ⤷ 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 | PA2016045 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| 1419152 | CA 2012 00019 | Denmark | ⤷ Sign Up | |
| 1632232 | PA2016043 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| 1663240 | 222 6-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
| 1663240 | 122015000088 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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