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Rilpivirine hydrochloride - Generic Drug Details
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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Rilpivirine hydrochloride has two hundred and twenty-seven patent family members in forty-three countries.
There are seven drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.
Summary for rilpivirine hydrochloride
| International Patents: | 227 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 7 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 74 |
| Patent Applications: | 19 |
| 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 |
|---|---|
| ViiV Healthcare | Phase 4 |
| Janssen, LP | Phase 3 |
| Augusta University | Phase 4 |
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 it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it 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 it Free | ⤷ Try it Free |
| Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for rilpivirine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100817453 | ⤷ Try it Free |
| Norway | 2014030 | ⤷ Try it Free |
| Eurasian Patent Organization | 014840 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for rilpivirine hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663240 | 132016000129162 | Italy | ⤷ Try it Free | PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623 |
| 1663240 | 122016000109 | Germany | ⤷ Try it Free | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621 |
| 1419152 | SPC/GB12/025 | United Kingdom | ⤷ Try it Free | PRODUCT NAME: A COMBINATION OF RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE.; REGISTERED: UK EU/1/11/737/001 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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