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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for EDURANT?
- What are the global sales for EDURANT?
- What is Average Wholesale Price for EDURANT?
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 |
![EDURANT drug patent expirations Drug patent expirations by year for EDURANT](/p/graph/s/t/EDURANT-patent-expirations.png)
![Drug Prices for EDURANT](/p/graph/drug-price/EDURANT.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EDURANT
Generic Entry Date for EDURANT*:
Constraining patent/regulatory 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 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 | 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 |
---|---|---|---|
Costa Rica | 9032 | FUMARATO DE 4-((4-((4-(2-CIANOETENIL)-2,6-DIMETILFENIL)AMINO-2- PIRIMIDINIL)AMINO)BENZONITRILO | ⤷ Sign Up |
Poland | 1663240 | ⤷ Sign Up | |
Australia | 2001233979 | ⤷ Sign Up | |
Spain | 2371442 | ⤷ Sign Up | |
Israel | 160328 | PYRIMIDINE DERIVATIVES, PROCESS AND INTERMEDIATES FOR PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM FOR INHIBITING HIV | ⤷ Sign Up |
Norway | 2016026 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EDURANT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3808743 | 2290034-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF RILPIVRINE OR A THERAPEUTICALLY EQIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128 |
1663240 | 300851 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623 |
1419152 | C300532 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1663240 | 15C0073 | France | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
3808743 | C 2022 032 | Romania | ⤷ Sign Up | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SAU UN N-OXID, O SARE DE ADITIE ACCEPTABILA FARMACEUTIC, INCLUSIV SAREA CLORHIDRAT A RILPIVIRINEI SAU O FORMA IZOMERICA STEREOCHIMICA A RILPIVIRINEI SI EMTRICITABINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001-002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20111128 |
1663240 | 93382 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |