EDURANT PED Drug Patent Profile
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When do Edurant Ped patents expire, and what generic alternatives are available?
Edurant Ped is a drug marketed by Janssen Prods and is included in one NDA. There are two patents protecting this drug.
This drug has two hundred and twenty-one patent family members in forty-five countries.
The generic ingredient in EDURANT PED 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 Ped
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 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 PED
| International Patents: | 221 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 14 |
| Patent Applications: | 99 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EDURANT PED |
| DailyMed Link: | EDURANT PED at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EDURANT PED
*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 PED
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 PED
US Patents and Regulatory Information for EDURANT PED
EDURANT PED is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EDURANT PED 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 PED
Dispersible compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
HIV inhibiting pyrimidines derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE PATIENTS 2 YEARS OF AGE AND OLDER, WEIGHING AT LEAST 14KG, WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY
| 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 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 |
International Patents for EDURANT PED
See the table below for patents covering EDURANT PED around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P20192051 | DERIVATI PIRIMIDINA KOJI INHIBIRAJU HIV (HIV INHIBITING PYRIMIDINES DERIVATIVES) | ⤷ Sign Up |
| Japan | 2008511591 | ⤷ Sign Up | |
| Slovenia | 1419152 | ⤷ Sign Up | |
| South Korea | 20130127515 | COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EDURANT PED
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1419152 | C20120012 00058 | Estonia | ⤷ Sign Up | PRODUCT NAME: EVIPLERA - EMTRITSITABIIN/RILPIVIRIIN (HUEDRO-;REG NO/DATE: C(2011)8956 FINAL 28.11.2011 |
| 1663240 | 93383 | 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,EMTRICITABINE, 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 |
| 1663240 | 300781 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
| 2932970 | 1890039-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518 |
| >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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