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 two branded drugs marketed by Janssen Prods and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Rilpivirine hydrochloride has two hundred and twenty-six patent family members in forty-six countries.
There are seven drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.
Summary for rilpivirine hydrochloride
International Patents: | 226 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 26 |
Clinical Trials: | 89 |
Patent Applications: | 286 |
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 |
---|---|
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Phase 4 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 1/Phase 2 |
Janssen Research & Development, LLC | Phase 1/Phase 2 |
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
Anatomical Therapeutic Chemical (ATC) Classes 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 for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
>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 for Free | ⤷ Try for Free |
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try for Free | ⤷ Try for Free |
Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | ⤷ Try for Free | ⤷ Try for Free |
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rilpivirine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ukraine | 78221 | ПРОИЗВОДНЫЕ ПИРИМИДИНОВ, ИНГИБИРУЮЩИЕ ВИЧ;ПОХІДНІ ПІРИМІДИНІВ, ЩО ІНГІБУЮТЬ ВІЛ (PYRIMIDINE DERIVATIVES INHIBITING HIV) | ⤷ Try for Free |
Japan | 4838396 | ⤷ Try for Free | |
Poland | 3528791 | ⤷ Try for Free | |
Spain | 2542017 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for rilpivirine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | PA2015035 | Lithuania | ⤷ Try for Free | PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128 |
3808743 | 122022000051 | Germany | ⤷ Try for Free | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE EIN PHARMAZEUTISCH AKZEPTABLES ADDITIONSSALZ VON RILPIVIRIN, EINSCHLIESSLICH DES SALZSAEURESALZES VON RILPIVIRIN, UND EMTRICITABIN.; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1663240 | CA 2016 00063 | Denmark | ⤷ Try for Free | PRODUCT NAME: RILPIVIRIN ELLER TERAPEUTISK AEKVIVALENT FORM DERAF BESKYTTET AF GRUNDPATENTET SASOM ET FARMACEUTISK ACCEPTABELT SALT FX HYDROCHLORIDSALTET AF RILPIVIRIN OG TENOFOVIRALAFENAMID ELLER FARMACEUTISK ACCEPTABELT SALT DERAF FX TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 |
1663240 | 122015000087 | Germany | ⤷ Try for Free | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory of Rilpivirine Hydrochloride
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