Isentress is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 10 US drug patents filed from 2013 to 2023. Out of these, 4 drug patents are active and 6 have expired. Isentress's patents have been open to challenges since 22 May, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 02, 2030. Details of Isentress's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8771733 | Pharmaceutical composition containing an anti-nucleating agent |
Jun, 2030
(5 years from now) | Active |
| US7754731 | Potassium salt of an HIV integrase inhibitor |
Mar, 2029
(3 years from now) | Active |
| US8852632 | Pharmaceutical formulation containing a release rate controlling composition |
Jan, 2028
(2 years from now) | Active |
| US7169780 | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Oct, 2023
(1 year, 7 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7754731 (Pediatric) | Potassium salt of an HIV integrase inhibitor |
Sep, 2029
(4 years from now) | Active |
|
US7169780 (Pediatric) | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Apr, 2024
(1 year, 1 month ago) |
Expired
|
| US7169780 | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Oct, 2023
(1 year, 7 months ago) |
Expired
|
|
US7217713 (Pediatric) | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Apr, 2023
(2 years ago) |
Expired
|
|
US7435734 (Pediatric) | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Apr, 2023
(2 years ago) |
Expired
|
| US7435734 | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Oct, 2022
(2 years ago) |
Expired
|
| US7217713 | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Oct, 2022
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Isentress's patents.
Latest Legal Activities on Isentress's Patents
Given below is the list of recent legal activities going on the following patents of Isentress.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2022 | US8852632 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Dec, 2021 | US8771733 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Dec, 2021 | US7754731 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Mar, 2020 | US7435734 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Oct, 2018 | US7217713 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jun, 2018 | US7169780 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Mar, 2018 | US8852632 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Dec, 2017 | US7754731 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Dec, 2017 | US8771733 |
| Recordation of Patent Grant Mailed Critical | 07 Oct, 2014 | US8852632 |
FDA has granted several exclusivities to Isentress. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Isentress, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Isentress.
Exclusivity Information
Isentress holds 6 exclusivities. All of its exclusivities have expired in 2021. Details of Isentress's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 12, 2012 |
| New Dosage Form(NDF) | Dec 20, 2016 |
| New Patient Population(NPP) | Nov 22, 2020 |
| M(M-114) | Mar 28, 2015 |
| New Dosing Schedule(D-167) | May 26, 2020 |
| Pediatric Exclusivity(PED) | May 22, 2021 |
Several oppositions have been filed on Isentress's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Isentress's generic, the next section provides detailed information on ongoing and past EP oppositions related to Isentress patents.
Isentress's Oppositions Filed in EPO
Isentress has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 20, 2014, by Sölch, Günter. This opposition was filed on patent number EP05852839A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16198994A | Jan, 2020 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP16198994A | Dec, 2019 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP05852790A | Aug, 2017 | Georg Kalhammer/Stephan Teipel | Patent maintained as amended |
| EP05852790A | Aug, 2017 | Ter Meer Steinmeister & Partner Patentanwälte mbB | Patent maintained as amended |
| EP05852839A | Aug, 2014 | Sölch, Günter | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Isentress is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Isentress's family patents as well as insights into ongoing legal events on those patents.
Isentress's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Isentress's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 02, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Isentress Generic API suppliers:
Raltegravir Potassium is the generic name for the brand Isentress. 2 different companies have already filed for the generic of Isentress, with Hetero Labs Ltd Iii having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Isentress's generic
How can I launch a generic of Isentress before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Isentress's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Isentress's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Isentress -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg | 12 Oct, 2011 | 1 | 11 Mar, 2029 | ||
| 600 mg | 21 Oct, 2022 | 1 | 30 Mar, 2032 |
Alternative Brands for Isentress
Isentress which is used for treating HIV infection by inhibiting integrase., has several other brand drugs in the same treatment category and using the same active ingredient (Raltegravir Potassium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie |
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| Agouron Pharms |
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| Bristol Myers Squibb |
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| Gilead |
| |||||||||||||||
| Gilead Sciences |
| |||||||||||||||
| Gilead Sciences Inc |
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| Glaxosmithkline |
| |||||||||||||||
| Msd Sub Merck |
| |||||||||||||||
| Viiv Hlthcare |
| |||||||||||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Raltegravir Potassium. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Merck Sharp Dohme |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Raltegravir Potassium, Isentress's active ingredient. Check the complete list of approved generic manufacturers for Isentress
About Isentress
Isentress is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for treating HIV infection by inhibiting integrase. Isentress uses Raltegravir Potassium as an active ingredient. Isentress was launched by Msd Sub Merck in 2007.
Approval Date:
Isentress was approved by FDA for market use on 12 October, 2007.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Isentress is 12 October, 2007, its NCE-1 date is estimated to be 22 May, 2020.
Active Ingredient:
Isentress uses Raltegravir Potassium as the active ingredient. Check out other Drugs and Companies using Raltegravir Potassium ingredient
Treatment:
Isentress is used for treating HIV infection by inhibiting integrase.
Dosage:
Isentress is available in the following dosage forms - tablet, chewable form for oral use, powder form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 400MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET, CHEWABLE | Prescription | ORAL |
| EQ 100MG BASE/PACKET | POWDER | Prescription | ORAL |
| EQ 25MG BASE | TABLET, CHEWABLE | Prescription | ORAL |