RILPIVIRINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for rilpivirine hydrochloride and what is the scope of patent protection?
Rilpivirine hydrochloride
is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Rilpivirine hydrochloride has one hundred and ninety-nine patent family members in forty-two countries.
There are seven drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.
Summary for RILPIVIRINE HYDROCHLORIDE
| International Patents: | 199 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 7 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 26 |
| Clinical Trials: | 87 |
| Patent Applications: | 286 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RILPIVIRINE HYDROCHLORIDE |
| What excipients (inactive ingredients) are in RILPIVIRINE HYDROCHLORIDE? | RILPIVIRINE HYDROCHLORIDE excipients list |
| DailyMed Link: | RILPIVIRINE HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RILPIVIRINE HYDROCHLORIDE
Generic Entry Date for RILPIVIRINE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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 RILPIVIRINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1/Phase 2 |
| Janssen Research & Development, LLC | Phase 1/Phase 2 |
| Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Phase 3 |
Pharmacology for RILPIVIRINE HYDROCHLORIDE
| Drug Class | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor |
| Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for RILPIVIRINE HYDROCHLORIDE
US Patents and Regulatory Information for RILPIVIRINE HYDROCHLORIDE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 RILPIVIRINE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RILPIVIRINE HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 2016025 | ⤷ Try a Trial | |
| Lithuania | PA2016043 | ⤷ Try a Trial | |
| Austria | 508748 | ⤷ Try a Trial | |
| Japan | 5539927 | ⤷ Try a Trial | |
| Taiwan | I315199 | ⤷ Try a Trial | |
| Slovenia | 1789139 | ⤷ Try a Trial | |
| Norway | 20071720 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RILPIVIRINE HYDROCHLORIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1419152 | 92008 | Luxembourg | ⤷ Try a Trial | 92008, EXPIRES: 20261128 |
| 1663240 | 223 5021-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
| 1663240 | 59/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
| 1663240 | 300768 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
| 1663240 | C 2015 038 | Romania | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE DE RILPIVIRINA SAU O FORMA TERAPEUTIC ECHIVALENTA A ACESTEIA, CUM AR FI O SARE DE RILPIVIRINA ACCEPTABILA FARMACEUTIC, INCLUSIV CLORHIDRATUL DE RILPIVIRINA 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 |
| 1632232 | PA2016043 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| 1663240 | CA 2015 00055 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128 |
| >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.
ISSN: 2162-2639
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