Raltegravir potassium - Generic Drug Details

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What are the generic drug 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				⤷ 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	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		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	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011		RX	Yes	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 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
Croatia	P20120066		⤷ Sign Up
Canada	2588445	PREPARATION PHARMACEUTIQUE CONTENANT UNE COMPOSITION DE CONTROLE DU TAUX DE LIBERATION (PHARMACEUTICAL FORMULATION OF CARBOXAMIDE HIV INTEGRASE INHIBITORS CONTAINING A RELEASE RATE CONTROLLING COMPOSITION)	⤷ Sign Up
Israel	183615	PHARMACEUTICAL FORMULATION OF CARBOXAMIDE HIV INTEGRASE INHIBITORS CONTAINING A RELEASE RATE CONTROLLING COMPOSITION	⤷ Sign Up
Cyprus	1124914		⤷ Sign Up
Iceland	7213		⤷ Sign Up
Australia	2005311652	Pharmaceutical formulation of carboxamide HIV integrase inhibitors containing a release rate controlling composition	⤷ 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	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	08C0026	France	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
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	SPC010/2008	Ireland	⤷ Sign Up	SPC010/2008: 20091119, EXPIRES: 20221219
1441735	91428	Luxembourg	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080102
1441735	300340	Netherlands	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102
>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.