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 |
---|---|
St. Michael's Hospital, Toronto | Phase 2 |
Canadian Institutes of Health Research (CIHR) | Phase 2 |
Unity Health 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 | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Msd Sub Merck | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 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 |
---|---|---|---|
Hungary | S1600016 | ⤷ Try a Trial | |
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 |
Australia | 2010313571 | Solid pharmaceutical compositions containing an integrase inhibitor | ⤷ Try a Trial |
Croatia | P20211826 | ⤷ 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 00016 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801 |
1441735 | 2008/010 | Ireland | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220; |
1441735 | 08C0026 | France | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102 |
1441735 | PA2008 007, C1441735 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |