LAMIVUDINE; RALTEGRAVIR POTASSIUM - Generic Drug Details

What are the generic drug sources for lamivudine; raltegravir potassium and what is the scope of freedom to operate?

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

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.

Recent Clinical Trials for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St. James's Hospital, Ireland	Phase 4

See all LAMIVUDINE; RALTEGRAVIR POTASSIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LAMIVUDINE; RALTEGRAVIR POTASSIUM

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No					Y

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
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015

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

International Patents for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112859
China	1700918
Colombia	5580777	INHIBIDORES DE HIDROXIPIRIMIDINONA CARBOXAMIDA N-SUSTITUIDOS DE VIH INTEGRASA
Hungary	230248	N-szubsztituált hidroxipirimidinon-karboxamid HIV-integráz inhibitorok (N-substituted hydroxypyrimidinone carboxamide inhibitors of hiv integrase)
Iceland	2436
Eurasian Patent Organization	200400585

Supplementary Protection Certificates for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	DO 67; 3-2008	Slovakia		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	C300340	Netherlands		PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
1441735	SPC010/2008	Ireland		SPC010/2008: 20091119, EXPIRES: 20221219
1441735	67 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102
3494972	2024C/522	Belgium		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703