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ISENTRESS HD Drug Profile
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When do Isentress Hd patents expire, 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. Five 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 12th, 2011.
Summary for ISENTRESS HD
| International Patents: | 115 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| 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 |
|---|---|
| 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
| 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 |
|---|---|---|
| Japan | 4705956 | Start Trial |
| Russian Federation | 2012121857 | Start Trial |
| India | 3377DEN2012 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03035077 | Start Trial |
| New Zealand | 555376 | Start Trial |
| Poland | 369223 | 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 | C300340 | Netherlands | Start Trial | PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
| 1441735 | C 2008 008 | Romania | Start 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 | SPC/GB08/020 | United Kingdom | Start Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023. |
| 1441735 | 20221021 | Netherlands | Start Trial | 20221021, EXPIRES: 20221219 |
| 1441735 | C20080001 00016 | Estonia | Start Trial | PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801 |
| 1441735 | 30/2008 | Austria | Start Trial | PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436/001- EU/1/07/436/002 20071220 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
