Lamivudine; raltegravir potassium - Generic Drug Details
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What are the generic drug sources for lamivudine; raltegravir potassium and what is the scope of patent protection?
Lamivudine; raltegravir potassium
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lamivudine; raltegravir potassium has ninety-five patent family members in forty-three countries.
Summary for lamivudine; raltegravir potassium
| International Patents: | 95 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| DailyMed Link: | lamivudine; raltegravir potassium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lamivudine; raltegravir potassium
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for lamivudine; raltegravir potassium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. James's Hospital, Ireland | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for lamivudine; raltegravir potassium
US Patents and Regulatory Information for lamivudine; raltegravir potassium
| 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 | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for lamivudine; raltegravir potassium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for lamivudine; raltegravir potassium
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme Limited | Dutrebis | lamivudine, raltegravir potassium | EMEA/H/C/003823 Dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1). |
Withdrawn | no | no | no | 2015-03-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for lamivudine; raltegravir potassium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P20040373 | N-SUPSTITUIRANI HIDROKSIPIRIDINON KARBOKSAMID INHIBITORI HIV INTEGRAZE (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE) | ⤷ Sign Up |
| Morocco | 29120 | SEL DE POTASSIUM D'UN INHIBITEUR DE L'INTEGRASE DU VIH | ⤷ Sign Up |
| Brazil | PI0213522 | compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto | ⤷ Sign Up |
| Brazil | 0213522 | compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lamivudine; raltegravir potassium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3494972 | 2024C/522 | Belgium | ⤷ Sign Up | PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703 |
| 1441735 | PA2008007,C1441735 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220 |
| 1441735 | C20080001 00016 | Estonia | ⤷ Sign Up | PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801 |
| 1441735 | 08C0026 | France | ⤷ Sign Up | PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
