RALTEGRAVIR POTASSIUM - Generic Drug Details

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What are the generic sources for raltegravir potassium and what is the scope of patent protection?

Raltegravir potassium is the generic ingredient in two branded drugs marketed by Msd Sub Merck and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Raltegravir potassium has one hundred and fifty-eight patent family members in forty-six countries.

There are five drug master file entries for raltegravir potassium. Nine suppliers are listed for this compound.

Summary for RALTEGRAVIR POTASSIUM

International Patents:	158
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	5
Patent Applications:	239
DailyMed Link:	RALTEGRAVIR POTASSIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RALTEGRAVIR POTASSIUM

Generic Entry Dates for RALTEGRAVIR POTASSIUM^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: POWDER;ORAL
Generic Entry Dates for RALTEGRAVIR POTASSIUM^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET, CHEWABLE;ORAL
Generic Entry Dates for RALTEGRAVIR POTASSIUM^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 RALTEGRAVIR POTASSIUM

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

Sponsor	Phase
St. James's Hospital, Ireland	Phase 4
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Phase 1/Phase 2
ANRS, Emerging Infectious Diseases	Phase 1/Phase 2

See all RALTEGRAVIR POTASSIUM clinical trials

Pharmacology for RALTEGRAVIR POTASSIUM

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors

Medical Subject Heading (MeSH) Categories for RALTEGRAVIR POTASSIUM

Anti-HIV Agents
HIV Integrase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RALTEGRAVIR POTASSIUM

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

Paragraph IV (Patent) Challenges for RALTEGRAVIR POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISENTRESS HD	Tablets	raltegravir potassium	600 mg	022145	1	2022-10-21
ISENTRESS HD	Tablets	raltegravir potassium	400 mg	022145	1	2011-10-12

US Patents and Regulatory Information for RALTEGRAVIR POTASSIUM

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	⤷ 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 RALTEGRAVIR POTASSIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011	⤷ Sign Up	⤷ Sign Up
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for RALTEGRAVIR POTASSIUM

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Country	Patent Number	Title	Estimated Expiration
Montenegro	00427	N-SUPSTITUISANI HIDROKSIPIRAMIDINON KARBOKSAMIDNI INHIBITORI HIV INTEGRAZE (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE)	⤷ Sign Up
Norway	20042165		⤷ Sign Up
Japan	2005511543		⤷ Sign Up
Austria	E534645		⤷ Sign Up
Russian Federation	2382648	ФАРМАЦЕВТИЧЕСКИЙ СОСТАВ КАРБОКСАМИДНЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ, СОДЕРЖАЩИЙ КОМПОЗИЦИЮ С КОНТРОЛИРУЕМОЙ СКОРОСТЬЮ ВЫСВОБОЖДЕНИЯ (PHARMACEUTICAL COMPOSITION OF CARBOXAMIDE INHIBITORS OF HIV INTEGRASE, CONTAINING COMPOSITION WITH CONTROLLED RATE OF RELEASE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006060730		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RALTEGRAVIR POTASSIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	319	Finland	⤷ Sign Up
1441735	SZ 30/2008	Austria	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1441735	C 2008 008	Romania	⤷ Sign Up	PRODUCT NAME: N-(2-(4-(4-FLUOROBENZILCARBAMOIL)-5-HIDROXI-1-METIL-6-OXO-1,6-DIHIDROPIRIMIDIN-2-IL)PROPAN-2+IL)-5-METIL-1,3,4-OXADIAZOL-2-CARBOXAMIDA - RALTEGRAVIR SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA, INSPECIAL SAREA DE POTASIU; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF NATIONAL AUTHORISATION: 20071220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/07/436/001, EMEA EU/1/07/436/002; DATE OF FIRST AUTHORISATION IN EEA: 20071220
1441735	PA2008007	Lithuania	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
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	DO 67; 3-2008	Slovakia	⤷ Sign Up	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
>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.