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isentress hd Drug Patent Profile

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When do Isentress Hd patents expire, and what generic alternatives are available?

Isentress Hd is a drug marketed by Msd Sub Merck and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-nine patent family members in forty-six countries.

The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

DrugPatentWatch^® Generic Entry Outlook for Isentress Hd

Isentress Hd was eligible for patent challenges on October 12, 2011.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for isentress hd

International Patents:	139
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	88
Patent Applications:	106
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for isentress hd
DailyMed Link:	isentress hd at DailyMed

Drug patent expirations by year for isentress hd

Recent Clinical Trials for isentress hd

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

Sponsor	Phase
Unity Health Toronto	Phase 2
St. Michael's Hospital, Toronto	Phase 2
Canadian Institutes of Health Research (CIHR)	Phase 2

See all isentress hd clinical trials

Pharmacology for isentress hd

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

Paragraph IV (Patent) Challenges for ISENTRESS HD

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 isentress hd

isentress hd is protected by five US patents.

Patents protecting isentress hd

Solid pharmaceutical compositions containing an integrase inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION

N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Potassium salt of an HIV integrase inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical composition containing an anti-nucleating agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Solid pharmaceutical compositions containing an integrase inhibitor
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Patent Expiration: ⤷ Sign Up

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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 HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		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
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	⤷ 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 isentress hd

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	⤷ 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 HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for isentress hd

See the table below for patents covering isentress hd around the world.

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	007060	N-ЗАМЕЩЁННЫЕ ГИДРОКСИПИРИМИДИНОН-КАРБОКСАМИДНЫЕ ИНГИБИТОРЫ ВИЧ ИНТЕГРАЗЫ (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE)	⤷ Sign Up
Poland	212914		⤷ Sign Up
Japan	2008521929		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for isentress hd

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	C20080001	Estonia	⤷ Sign Up	PRODUCT NAME: ISENTRESS; AUTHORISATION NO.: EMA/106827/2018; AUTHORISATION DATE: 20180222
1441735	67 3-2008	Slovakia	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description