Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Baxter
Medtronic
Colorcon
AstraZeneca

Last Updated: January 22, 2020

DrugPatentWatch Database Preview

ISENTRESS HD Drug Profile

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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

Isentress Hd is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and fifteen patent family members in forty-four countries.

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

US ANDA Litigation and Generic Entry Outlook for Isentress Hd

  Start Trial

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

Summary for ISENTRESS HD
Drug patent expirations by year for ISENTRESS HD
Drug Prices for ISENTRESS HD

See drug prices for ISENTRESS HD

Recent Clinical Trials for ISENTRESS HD

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

SponsorPhase
CIHR Canadian HIV Trials NetworkPhase 2
St. Michael's Hospital, TorontoPhase 2
Canadian Institutes of Health Research (CIHR)Phase 2

See all ISENTRESS HD clinical trials

Pharmacology for ISENTRESS HD
Paragraph IV (Patent) Challenges for ISENTRESS HD
Tradename Dosage Ingredient NDA Submissiondate
ISENTRESS TABLET;ORAL raltegravir potassium 022145 2011-10-12
ISENTRESS HD TABLET;ORAL raltegravir potassium 022145 2011-10-12

US Patents and Regulatory Information for ISENTRESS HD

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 ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ISENTRESS HD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441735 C300340 Netherlands   Start Trial PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735 C 2008 008 Romania   Start Trial 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 SPC/GB08/020 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/020 GRANTED TO ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. IN RESPECT OF THE PRODUCT RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6346 DATED 05 JANUARY 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 01 JANUARY 2023.
1441735 20221021 Netherlands   Start Trial 20221021, EXPIRES: 20221219
1441735 C20080001 00016 Estonia   Start Trial PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1441735 30/2008 Austria   Start Trial PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436/001- EU/1/07/436/002 20071220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim
Mallinckrodt
Baxter
Harvard Business School

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 verifification 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.