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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 is one patent 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
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

Drug patent expirations by year for EDURANT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EDURANT

Generic Entry Date for EDURANT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 202022 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 EDURANT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Aptorum International Limited	Phase 1
ViiV Healthcare	Phase 1/Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2

See all EDURANT clinical trials

Pharmacology for EDURANT

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EDURANT

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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				⤷ 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

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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.

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Country	Patent Number	Title	Estimated Expiration
Hungary	S1500055		⤷ Sign Up
Hungary	S1500053		⤷ Sign Up
European Patent Office	1663240	COMBINAISON D'UN INHIBITEUR NON-NUCLEOSIDIQUE DE LA TRANSCRIPTASE INVERSE (NNRTI) CONTENANT UNE PYRIMIDINE AVEC UN INHIBITEUR NUCLEOSIDIQUE DE LA TRANSCRIPTASE INVERSE (NRTI) (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS)	⤷ Sign Up
Poland	1663240		⤷ Sign Up
Canada	2537095	COMBINAISONS D'UNE PYRIMIDINE RENFERMANT NNRTI AVEC DES INHIBITEURS DE RT (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS)	⤷ Sign Up
Luxembourg	92001		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EDURANT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1632232	122016000111	Germany	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240	379 5033-2016	Slovakia	⤷ Sign Up	PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRA- NENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1419152	132012902053326	Italy	⤷ Sign Up	PRODUCT NAME: RILPIVIRINA CLORIDRATO(EDURANT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/736/001, 20111128
1663240	132016000129162	Italy	⤷ Sign Up	PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623
1663240	PA2015035,C1663240	Lithuania	⤷ Sign Up	PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1419152	1290017-1	Sweden	⤷ Sign Up	PRODUCT NAME: RILPIVIRIN OCH FARMACEUTISKT GODTAGBARA ADDITIONSSALTER DAERAV, INBEGRIPET VAETEKLORSYRASALTET AV RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description