DrugPatentWatch Database Preview
ISENTRESS HD Drug Profile
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 fourteen 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.
Summary for ISENTRESS HD
| International Patents: | 114 |
| 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 | |||
| >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 |
|---|---|---|
| Germany | 60209381 | Start Trial |
| Israel | 183614 | Start Trial |
| Spain | 2375788 | 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 | C01441735/01 | Switzerland | Start Trial | FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT |
| 1441735 | CA 2008 00021 | Denmark | Start Trial | |
| 1441735 | SPC010/2008 | Ireland | Start Trial | SPC010/2008: 20091119, EXPIRES: 20221219 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
