ISENTRESS HD Drug Patent Profile
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Which patents cover Isentress Hd, and what generic alternatives are available?
Isentress Hd is a drug marketed by Msd Sub Merck and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and thirty-nine patent family members in forty-six countries.
The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
DrugPatentWatch® Generic Entry Outlook for Isentress Hd
Isentress Hd was eligible for patent challenges on October 12, 2011.
There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for ISENTRESS HD
International Patents: | 139 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 88 |
Patent Applications: | 126 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ISENTRESS HD |
DailyMed Link: | ISENTRESS HD at DailyMed |
Recent Clinical Trials for ISENTRESS HD
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Unity Health Toronto | Phase 2 |
St. Michael's Hospital, Toronto | Phase 2 |
Canadian Institutes of Health Research (CIHR) | Phase 2 |
Pharmacology for ISENTRESS HD
Drug Class | Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor |
Mechanism of Action | HIV Integrase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ISENTRESS HD
Paragraph IV (Patent) Challenges for ISENTRESS HD
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ISENTRESS HD | Tablets | raltegravir potassium | 600 mg | 022145 | 1 | 2022-10-21 |
ISENTRESS HD | Tablets | raltegravir potassium | 400 mg | 022145 | 1 | 2011-10-12 |
US Patents and Regulatory Information for ISENTRESS HD
ISENTRESS HD is protected by five US patents.
Patents protecting ISENTRESS HD
Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION
N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Potassium salt of an HIV integrase inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition containing an anti-nucleating agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Expired US Patents for ISENTRESS HD
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ISENTRESS HD
See the table below for patents covering ISENTRESS HD around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Luxembourg | 91428 | ⤷ Try a Trial | |
Argentina | 101429 | SAL POTÁSICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH | ⤷ Try a Trial |
Slovenia | 1819700 | ⤷ Try a Trial | |
China | 101068793 | Potassium salt of an HIV integrase inhibitor | ⤷ Try a Trial |
Eurasian Patent Organization | 007060 | N-ЗАМЕЩЁННЫЕ ГИДРОКСИПИРИМИДИНОН-КАРБОКСАМИДНЫЕ ИНГИБИТОРЫ ВИЧ ИНТЕГРАЗЫ (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE) | ⤷ Try a Trial |
Brazil | PI0518760 | sal de potÁssio do composto, e, composiÇço farmacÊutica | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ISENTRESS HD
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1441735 | C20080001 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222 |
1441735 | C 2008 008 | Romania | ⤷ Try a Trial | PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220 |
1441735 | DO 67; 3-2008 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT |
1441735 | 20221021 | Netherlands | ⤷ Try a Trial | 20221021, EXPIRES: 20221219 |
1441735 | PA2008007 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220 |
1441735 | SPC/GB08/020 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |