dolutegravir sodium; rilpivirine hydrochloride - Profile
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What are the generic sources for dolutegravir sodium; rilpivirine hydrochloride and what is the scope of freedom to operate?
Dolutegravir sodium; rilpivirine hydrochloride
is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Dolutegravir sodium; rilpivirine hydrochloride has three hundred and twenty-two patent family members in fifty-one countries.
Summary for dolutegravir sodium; rilpivirine hydrochloride
| International Patents: | 322 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dolutegravir sodium; rilpivirine hydrochloride |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium; rilpivirine hydrochloride
Generic Entry Date for dolutegravir sodium; 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.
Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JULUCA | Tablets | dolutegravir sodium; rilpivirine hydrochloride | 50 mg/25 mg | 210192 | 1 | 2019-11-19 |
US Patents and Regulatory Information for dolutegravir sodium; rilpivirine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | 10,426,780 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | 12,011,506 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | 8,129,385*PED | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | RX | Yes | Yes | 9,242,986*PED | ⤷ Start Trial | Y | ⤷ Start 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 dolutegravir sodium; rilpivirine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 8,080,551 | ⤷ Start Trial |
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 6,838,464 | ⤷ Start Trial |
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 8,101,629 | ⤷ Start Trial |
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 7,125,879 | ⤷ Start Trial |
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | 7,067,522 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dolutegravir sodium; rilpivirine hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3127542 | ⤷ Start Trial | |
| European Patent Office | 2527007 | Dérivé de carbamoylpyridone polycyclique doté d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity) | ⤷ Start Trial |
| South Korea | 101848819 | ⤷ Start Trial | |
| China | 110958883 | ⤷ Start Trial | |
| Taiwan | 201919586 | Combination and uses and treatments thereof | ⤷ Start Trial |
| Serbia | 65183 | ⤷ Start Trial | |
| Singapore | 10201509476R | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dolutegravir sodium; rilpivirine hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2465580 | 768 | Finland | ⤷ Start Trial | |
| 2465580 | 301109 | Netherlands | ⤷ Start Trial | PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217 |
| 3494972 | LUC00346 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703 |
| 1874117 | C201430032 | Spain | ⤷ Start Trial | PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
| 2932970 | LUC00090 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518 |
| 3494972 | PA2024516 | Lithuania | ⤷ Start Trial | PRODUCT NAME: DOLUTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA IR LAMIVUDINA; REGISTRATION NO/DATE: EU/1/19/1370 20190701 |
| 2465580 | 2190020-4 | Sweden | ⤷ Start Trial | PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Dolutegravir Sodium + Rilpivirine Hydrochloride: Investment Scenario and Fundamentals Analysis
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