Isentress Hd is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 12 US drug patents filed from 2017 to 2023. Out of these, 6 drug patents are active and 6 have expired. Isentress Hd'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 Mar 30, 2032. Details of Isentress Hd'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
(4 years from now) | Active |
| US7169780 | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Oct, 2023
(1 year, 1 month ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10772888 | Solid pharmaceutical compositions containing an integrase inhibitor |
Mar, 2032
(7 years from now) | Active |
|
US9649311 (Pediatric) | Solid pharmaceutical compositions containing an integrase inhibitor |
Apr, 2031
(6 years from now) | Active |
| US9649311 | Solid pharmaceutical compositions containing an integrase inhibitor |
Oct, 2030
(5 years from now) | Active |
|
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
(7 months ago) |
Expired
|
|
US7435734 (Pediatric) | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Apr, 2023
(1 year, 6 months ago) |
Expired
|
|
US7217713 (Pediatric) | N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase |
Apr, 2023
(1 year, 6 months 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 Hd's patents.
Latest Legal Activities on Isentress Hd's Patents
Given below is the list of recent legal activities going on the following patents of Isentress Hd.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Feb, 2024 | US10772888 |
| 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, 4th Year, Large Entity | 28 Sep, 2020 | US9649311 |
| Recordation of Patent Grant Mailed Critical | 15 Sep, 2020 | US10772888 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Sep, 2020 | US10772888 |
| Email Notification Critical | 27 Aug, 2020 | US10772888 |
| Issue Notification Mailed Critical | 26 Aug, 2020 | US10772888 |
| Dispatch to FDC | 18 Aug, 2020 | US10772888 |
| Application Is Considered Ready for Issue Critical | 18 Aug, 2020 | US10772888 |
FDA has granted several exclusivities to Isentress Hd. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Isentress Hd, 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 Hd.
Exclusivity Information
Isentress Hd holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Isentress Hd's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | May 26, 2020 |
| New Patient Population(NPP) | Nov 22, 2020 |
| Pediatric Exclusivity(PED) | May 22, 2021 |
Several oppositions have been filed on Isentress Hd'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 Hd's generic, the next section provides detailed information on ongoing and past EP oppositions related to Isentress Hd patents.
Isentress Hd's Oppositions Filed in EPO
Isentress Hd has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 11, 2017, by Ter Meer Steinmeister & Partner Patentanwälte Mbb. This opposition was filed on patent number EP05852790A. 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 |
US patents provide insights into the exclusivity only within the United States, but Isentress Hd 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 Hd's family patents as well as insights into ongoing legal events on those patents.
Isentress Hd's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Isentress Hd's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 30, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Isentress Hd Generics:
There are no approved generic versions for Isentress Hd as of now.
How can I launch a generic of Isentress Hd before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Isentress Hd's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Isentress Hd'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 Hd -
| 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 Hd
Isentress Hd which is used for treating HIV infection., 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 |
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| Gilead Sciences |
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| Gilead Sciences Inc |
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| Glaxosmithkline |
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| Merck Sharp Dohme |
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| Msd Sub Merck |
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| Viiv Hlthcare |
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About Isentress Hd
Isentress Hd is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for treating HIV infection. Isentress Hd uses Raltegravir Potassium as an active ingredient. Isentress Hd was launched by Msd Sub Merck in 2007.
Approval Date:
Isentress Hd 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 Hd is 12 October, 2007, its NCE-1 date is estimated to be 22 May, 2020.
Active Ingredient:
Isentress Hd uses Raltegravir Potassium as the active ingredient. Check out other Drugs and Companies using Raltegravir Potassium ingredient
Treatment:
Isentress Hd is used for treating HIV infection.
Dosage:
Isentress Hd is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 600MG BASE | TABLET | Prescription | ORAL |