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ISENTRESS HD Drug Profile
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» See Plans and PricingWhich 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 five patents protecting this drug.
This drug has one hundred and fifteen patent family members in forty-four countries.
The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
US ANDA Litigation and Generic Entry Outlook for Isentress Hd
Isentress Hd was eligible for patent challenges on October 12, 2011.
Indicators of Generic Entry
Summary for ISENTRESS HD
| International Patents: | 115 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 6 |
| Clinical Trials: | 42 |
| 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 |
| CIHR Canadian HIV Trials Network | 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 |
Paragraph IV (Patent) Challenges for ISENTRESS HD
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ISENTRESS | TABLET;ORAL | raltegravir potassium | 022145 | 2011-10-12 |
| ISENTRESS HD | TABLET;ORAL | raltegravir potassium | 022145 | 2011-10-12 |
US Patents and Regulatory Information for ISENTRESS HD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | Start Trial | 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 |
International Patents for ISENTRESS HD
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2463976 | Start Trial |
| Norway | 20042165 | Start Trial |
| Austria | 534645 | Start Trial |
| Russian Federation | 2012121857 | Start Trial |
| India | 3377DEN2012 | Start Trial |
| Morocco | 29120 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ISENTRESS HD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1441735 | 08C0026 | France | Start Trial | PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102 |
| 1441735 | 122008000016 | Germany | Start 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 | PA2008 007, C1441735 | Lithuania | Start Trial | PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
| 1441735 | PA2008007 | Lithuania | Start Trial | PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220 |
| 1441735 | SPC/GB08/020 | United Kingdom | Start Trial | PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102 |
| 1441735 | CA 2008 00021 | Denmark | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
