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 are four patents 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: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 25 |
Clinical Trials: | 85 |
Patent Applications: | 318 |
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 |
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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | See Plans and Pricing | See Plans and Pricing |
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rilpivirine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 014840 | КОМБИНАЦИИ ПИРИМИДИНСОДЕРЖАЩЕГО NNRTI С ИНГИБИТОРАМИ ОБРАТНОЙ ТРАНСКРИПТАЗЫ (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS) | See Plans and Pricing |
Hungary | S1500053 | See Plans and Pricing | |
Poland | 402388 | Pochodna pirymidyny, jej zastosowanie i kompozycja farmaceutyczna ja zawierajaca (Pyrimidine derivative, its use and a pharmaceutical composition containing it) | See Plans and Pricing |
Japan | 2015044839 | ピリミジンを含有するNNRTIとRTインヒビターとの組み合わせ物 (COMBINATION OF NNRTI CONTAINING PYRIMIDINE WITH RT INHIBITOR) | See Plans and Pricing |
Japan | 2007520443 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for rilpivirine hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1419152 | 628 | Finland | See Plans and Pricing | |
1663240 | 2015/054 | Ireland | See Plans and Pricing | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
1663240 | PA2015035,C1663240 | Lithuania | See Plans and Pricing | PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128 |
1419152 | SPC/GB12/022 | United Kingdom | See Plans and Pricing | PRODUCT NAME: RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF.; REGISTERED: UK EU/1/11/736/001 20111128 |
1419152 | 125 5007-2012 | Slovakia | See Plans and Pricing | PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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