RALTEGRAVIR POTASSIUM - Generic Drug Details
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What are the generic sources for raltegravir potassium and what is the scope of patent protection?
Raltegravir potassium
is the generic ingredient in two branded drugs marketed by Msd Sub Merck and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Raltegravir potassium has one hundred and fifty-eight patent family members in forty-six countries.
There are five drug master file entries for raltegravir potassium. Nine suppliers are listed for this compound.
Summary for RALTEGRAVIR POTASSIUM
International Patents: | 158 |
US Patents: | 6 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 5 |
Patent Applications: | 239 |
Formulation / Manufacturing: | see details |
DailyMed Link: | RALTEGRAVIR POTASSIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RALTEGRAVIR POTASSIUM
Generic Entry Dates for RALTEGRAVIR POTASSIUM*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;ORAL |
Generic Entry Dates for RALTEGRAVIR POTASSIUM*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, CHEWABLE;ORAL |
Generic Entry Dates for RALTEGRAVIR POTASSIUM*:
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.
Recent Clinical Trials for RALTEGRAVIR POTASSIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
St. James's Hospital, Ireland | Phase 4 |
Merck Sharp & Dohme Corp. | Phase 1/Phase 2 |
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) | Phase 1/Phase 2 |
Pharmacology for RALTEGRAVIR POTASSIUM
Drug Class | Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor |
Mechanism of Action | HIV Integrase Inhibitors |
Medical Subject Heading (MeSH) Categories for RALTEGRAVIR POTASSIUM
Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM
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 RALTEGRAVIR POTASSIUM
Expired US Patents for RALTEGRAVIR POTASSIUM
International Patents for RALTEGRAVIR POTASSIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2586444 | Formulation pharmaceutique d'inhibiteurs de l'intégrase du VIH de type carboxamide contenant une composition de contrôle de vitesse de libération (Pharmaceutical formulation of carboxamide HIV integrase inhibitors containing a release rate control composition) | ⤷ Try a Trial |
Hong Kong | 1115011 | POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR HIV | ⤷ Try a Trial |
Russian Federation | 2012121857 | ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ИНГИБИТОР ИНТЕГРАЗЫ | ⤷ Try a Trial |
Cyprus | 1124914 | ⤷ Try a Trial | |
Brazil | 112012009857 | composições farmacêuticas sólidas contendo um inibidor de integrase | ⤷ Try a Trial |
Poland | 212914 | ⤷ Try a Trial | |
Norway | 325206 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RALTEGRAVIR POTASSIUM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
1441735 | C20080001 00016 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801 |
1441735 | 300340 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102 |
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 | CA 2008 00021 | Denmark | ⤷ Try a Trial | |
1441735 | 122008000016 | Germany | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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