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Last Updated: March 29, 2024

DUTREBIS Drug Patent Profile


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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: 25
Formulation / Manufacturing:see details
DailyMed Link:DUTREBIS at DailyMed
Drug patent expirations by year for DUTREBIS
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DUTREBIS
Generic Entry Date for DUTREBIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Potassium salt of an HIV integrase inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme DUTREBIS lamivudine; raltegravir potassium TABLET;ORAL 206510-001 Feb 6, 2015 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Patent: 1429
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05311671
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 18844
Estimated Expiration: ⤷  Try a Trial

Patent: 34645
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0518760
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 88398
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1068793
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 46
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120066
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12859
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2418
Estimated Expiration: ⤷  Try a Trial

Patent: 0701204
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 19683
Estimated Expiration: ⤷  Try a Trial

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0105086
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 15011
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3614
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 05956
Estimated Expiration: ⤷  Try a Trial

Patent: 08521933
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4320
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07006639
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 985
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 120
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5376
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 0700138
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 8784
Estimated Expiration: ⤷  Try a Trial

Patent: 073404
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 061148
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 197
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 19700
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0704130
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1350420
Estimated Expiration: ⤷  Try a Trial

Patent: 070089990
Estimated Expiration: ⤷  Try a Trial

Patent: 130122031
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 70136
Estimated Expiration: ⤷  Try a Trial

Patent: 75788
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 44463
Estimated Expiration: ⤷  Try a Trial

Patent: 0631944
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 07215
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 884
Estimated Expiration: ⤷  Try a Trial

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
China 1700918 ⤷  Try a Trial
Hungary 230248 N-szubsztituált hidroxipirimidinon-karboxamid HIV-integráz inhibitorok (N-substituted hydroxypyrimidinone carboxamide inhibitors of hiv integrase) ⤷  Try a Trial
Germany 60209381 ⤷  Try a Trial
Montenegro 01985 KALIJUMOVA SO INHIBITORA HIV INTEGRAZE (POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR) ⤷  Try a Trial
Georgia, Republic of P20063848 N-SUBSTITUTED HYDROXYPYRIMI-DINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUTREBIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 DO 67; 3-2008 Slovakia ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
1441735 SZ 30/2008 Austria ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735 SPC/GB08/020 United Kingdom ⤷  Try a Trial PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
1441735 SPC010/2008 Ireland ⤷  Try a Trial SPC010/2008: 20091119, EXPIRES: 20221219
1441735 C20080001 Estonia ⤷  Try a Trial PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
>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.