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
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 |
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.
Anatomical Therapeutic Chemical (ATC) Classes for DUTREBIS
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 |
---|---|---|---|
Yugoslavia | 35604 | ⤷ Try a Trial | |
Cyprus | 1112859 | ⤷ Try a Trial | |
Croatia | P20120066 | ⤷ Try a Trial | |
Spain | 2370136 | ⤷ 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 | 08C0026 | France | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102 |
1441735 | SPC010/2008 | Ireland | ⤷ Try a Trial | SPC010/2008: 20091119, EXPIRES: 20221219 |
1441735 | 300340 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102 |
1441735 | C01441735/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI S.P.A., IT |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |