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ISENTRESS HD Drug Profile
» See Plans and Pricing
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.
This drug has one hundred and seventeen 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. 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: | 117 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 75 |
| Clinical Trials: | 42 |
| Patent Applications: | 9 |
| 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 |
|---|---|
| CIHR Canadian HIV Trials Network | 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 |
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
International Patents for ISENTRESS HD
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Montenegro | 00427 | Start Trial |
| China | 102229605 | Start Trial |
| New Zealand | 555376 | Start Trial |
| Poland | 212914 | Start Trial |
| New Zealand | 533057 | Start Trial |
| Hong Kong | 1115011 | Start Trial |
| China | 102655752 | 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 | DO 67; 3-2008 | Slovakia | Start 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 | PA2008007,C1441735 | Lithuania | Start Trial | PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220 |
| 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 | 91428 | Luxembourg | Start Trial | PRODUCT NAME: ISENTRESS- RALTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080201 |
| 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 | 319 | Finland | Start Trial | |
| 1441735 | 0890018-5 | Sweden | Start Trial | PRODUCT NAME: RALTEGRAVIR |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
