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Rilpivirine hydrochloride - Generic Drug Details

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Rilpivirine hydrochloride is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventy-five patent family members in thirty-seven countries.

There are six drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.

Summary for Generic Name: rilpivirine hydrochloride

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYes7,125,879► subscribeYY ► subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYes► subscribe► subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYes7,067,522► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: rilpivirine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,841,310Combinations of a pyrimidine containing NNRTI with RT inhibitors► subscribe
7,956,063Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: rilpivirine hydrochloride

Country Document Number Estimated Expiration
Serbia51923► subscribe
Japan2005041878► subscribe
China102319433► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RILPIVIRINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012000035Germany► subscribePRODUCT NAME: RILPIVIRIN UND DESSEN STEREOCHEMISCH ISOMERE FORMEN, SOWIE DESSEN PHARMAZEUTISCH UNBEDENKLICHE ADDITIONSSALZE, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
0150039 00166Estonia► subscribePRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA EMTRITSITABIINI;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
853Luxembourg► subscribePRODUCT 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 L'EMTRICITABINE
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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 verifification 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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