dutrebis Drug Patent Profile
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When do Dutrebis patents expire, and what generic alternatives are available?
Dutrebis is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.
This drug has ninety-five patent family members in forty-three countries.
The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; raltegravir potassium profile page.
DrugPatentWatch® Generic Entry Outlook for Dutrebis
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 11, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for dutrebis
| International Patents: | 95 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 21 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | dutrebis at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dutrebis
*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.
US Patents and Regulatory Information for dutrebis
dutrebis is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of dutrebis is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting dutrebis
N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Potassium salt of an HIV integrase inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | Y | ⤷ Sign Up | |||
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | DISCN | No | No | ⤷ 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 |
Expired US Patents for dutrebis
| 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 dutrebis
| 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 dutrebis
When does loss-of-exclusivity occur for dutrebis?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2034
Patent: SAL POTASICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH
Estimated Expiration: ⤷ Sign Up
Patent: 1429
Patent: SAL POTÁSICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 05311671
Patent: Potassium salt of an HIV integrase inhibitor
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 18844
Estimated Expiration: ⤷ Sign Up
Patent: 34645
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0518760
Patent: sal de potÁssio do composto, e, composiÇço farmacÊutica
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 88398
Patent: SELS DE POTASSIUM D'UN INHIBITEUR D'INTEGRASE HIV (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1068793
Patent: Potassium salt of an HIV integrase inhibitor
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 46
Patent: SAL POTASICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0120066
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 12859
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 19700
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2418
Patent: КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 0701204
Patent: КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19683
Patent: SELS DE POTASSIUM D'UN INHIBITEUR D'INTEGRASE HIV (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 19700
Patent: SEL DE POTASSIUM D'UN INHIBITEUR DE L'INTEGRASE DU VIH (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0105086
Patent: POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 15011
Patent: POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR HIV
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3614
Patent: ANHYDROUS CRYSTALLINE POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 05956
Estimated Expiration: ⤷ Sign Up
Patent: 08521933
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4320
Patent: POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07006639
Patent: SAL DE POTASIO DE UN INHIBIDOR DE LA INTEGRASA DEL VIRUS DE INMUNODEFICIENCIA HUMANA. (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 985
Patent: KALIJUMOVA SO INHIBITORA HIV INTEGRAZE (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 120
Patent: SEL DE POTASSIUM D'UN INHIBITEUR DE L'INTEGRASE DU VIH
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5376
Patent: Anhydrous crystalline monopotassium salt of raltegravir
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 0700138
Patent: SAL POTASICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 8784
Estimated Expiration: ⤷ Sign Up
Patent: 073404
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 061148
Patent: SAL POTASICA DE N-(4-FLUOROBENCIL)-5-HIDROXI-1-METIL-2-(1-METIL-1-{[(5-METIL-1,3,4-OXADIAZOL-2-IL)CARBONIL]AMINO}ETIL)-6-OXO-1,6-DIHIDROPIRIMIDIN-4-CARBOXAMIDA
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 19700
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 19700
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 197
Patent: KALIJUMOVA SO INHIBITORA HIV INTEGRAZE (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 19700
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0704130
Patent: Protassium salt of an HIV integrase inhibitor
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1350420
Estimated Expiration: ⤷ Sign Up
Patent: 070089990
Patent: POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Patent: 130122031
Patent: POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 70136
Estimated Expiration: ⤷ Sign Up
Patent: 75788
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 44463
Estimated Expiration: ⤷ Sign Up
Patent: 0631944
Patent: Potassium salt of an HIV integrase inhibitor
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 07215
Patent: POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 884
Patent: БЕЗВОДНАЯ КРИСТАЛЛИЧЕСКАЯ КАЛИЕВАЯ СОЛЬ ИНГИБИТОРА ВИЧ-ИНТЕГРАЗЫ;БЕЗВОДНА КРИСТАЛІЧНА КАЛІЄВА СІЛЬ ІНГІБІТОРА ВІЛ-ІНТЕГРАЗИ (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering dutrebis around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2002334207 | ⤷ Sign Up | |
| Hungary | 230248 | N-szubsztituált hidroxipirimidinon-karboxamid HIV-integráz inhibitorok (N-substituted hydroxypyrimidinone carboxamide inhibitors of hiv integrase) | ⤷ Sign Up |
| Peru | 20061148 | SAL POTASICA DE N-(4-FLUOROBENCIL)-5-HIDROXI-1-METIL-2-(1-METIL-1-{[(5-METIL-1,3,4-OXADIAZOL-2-IL)CARBONIL]AMINO}ETIL)-6-OXO-1,6-DIHIDROPIRIMIDIN-4-CARBOXAMIDA | ⤷ Sign Up |
| Poland | 1819700 | ⤷ Sign Up | |
| Ukraine | 77454 | N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE | ⤷ Sign Up |
| Taiwan | 200631944 | Potassium salt of an HIV integrase inhibitor | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dutrebis
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1441735 | CA 2008 00021 | Denmark | ⤷ Sign Up | |
| 1441735 | SPC/GB08/020 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102 |
| 1441735 | 122008000016 | 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 |
| 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 | PA2008007 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220 |
| 1441735 | SZ 30/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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