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 Merck Sharp Dohme and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-six patent family members in forty-five countries.
The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Seven 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 is one Paragraph IV patent challenge 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: | 126 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 88 |
Patent Applications: | 147 |
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 |
---|---|
Canadian Institutes of Health Research (CIHR) | Phase 2 |
Unity Health Toronto | Phase 2 |
St. Michael's Hospital, Toronto | 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 | 400 mg | 022145 | 1 | 2011-10-12 |
US Patents and Regulatory Information for ISENTRESS HD
ISENTRESS HD is protected by six US patents.
Patents protecting ISENTRESS HD
Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION
N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Potassium salt of an HIV integrase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
International Patents for ISENTRESS HD
See the table below for patents covering ISENTRESS HD around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Malaysia | 162494 | SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING AN INTEGRASE INHIBITOR | See Plans and Pricing |
Mexico | 2007006639 | SAL DE POTASIO DE UN INHIBIDOR DE LA INTEGRASA DEL VIRUS DE INMUNODEFICIENCIA HUMANA. (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR.) | See Plans and Pricing |
Eurasian Patent Organization | 012418 | КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITORS) | See Plans and Pricing |
South Korea | 20130122031 | POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR | See Plans and Pricing |
Croatia | P20211826 | See Plans and Pricing | |
China | 102229605 | See Plans and Pricing | |
Colombia | 5580777 | INHIBIDORES DE HIDROXIPIRIMIDINONA CARBOXAMIDA N-SUSTITUIDOS DE VIH INTEGRASA | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ISENTRESS HD
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1441735 | PA2008 007, C1441735 | Lithuania | See Plans and Pricing | PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
1441735 | 122008000016 | Germany | See Plans and Pricing | PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
1441735 | PA2008007,C1441735 | Lithuania | See Plans and Pricing | PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220 |
1441735 | C20080001 | Estonia | See Plans and Pricing | PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222 |
1441735 | C300340 | Netherlands | See Plans and Pricing | PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
1441735 | 08C0026 | France | See Plans and Pricing | PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102 |
1441735 | SZ 30/2008 | Austria | See Plans and Pricing | PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |