DrugPatentWatch Database Preview
ISENTRESS HD Drug Profile
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When do Isentress Hd patents expire, and what generic alternatives are available?
This drug has one hundred and ten patent family members in forty-three countries.
The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.
Summary for ISENTRESS HD
| International Patents: | 110 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 10 |
| Clinical Trials: | 39 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ISENTRESS HD at DailyMed |
Medical Subject Heading (MeSH) Categories for ISENTRESS HD
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Merck Sharp Dohme | ISENTRESS HD | raltegravir potassium | TABLET;ORAL | 022145-002 | May 26, 2017 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for ISENTRESS HD
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,357,798 | Process for preparing N-alkylated hydroxypyrimidinone compounds | ➤ Sign Up |
| 7,820,660 | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ISENTRESS HD
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Austria | 534645 | ➤ Sign Up |
| Norway | 338784 | ➤ Sign Up |
| South Korea | 20040047981 | ➤ Sign Up |
| Ukraine | 87884 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ISENTRESS HD
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 00340 | Netherlands | ➤ Sign Up | PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
| 2008000016 | Germany | ➤ Sign Up | PRODUCT NAME: RALTEGRAVIR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES KALIUMSALZES; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220 |
| /2008 | Austria | ➤ Sign Up | 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 |
| 2008007 | Lithuania | ➤ Sign Up | PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
