Delstrigo is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is protected by 3 US drug patents filed from 2018 to 2021 out of which none have expired yet. Delstrigo's patents have been open to challenges since 30 August, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 29, 2036. Details of Delstrigo'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. | |||
| US8486975 | Non-nucleoside reverse transcriptase inhibitors |
Oct, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10603282 | Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine |
Nov, 2036
(11 years from now) | Active |
| US10842751 | Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine |
Nov, 2036
(11 years from now) | Active |
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 Delstrigo's patents.
Latest Legal Activities on Delstrigo's Patents
Given below is the list of recent legal activities going on the following patents of Delstrigo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Apr, 2024 | US10842751 |
| Notice of Final Determination -Eligible | 14 Mar, 2024 | US8486975 |
| FDA Final Eligibility Letter Critical | 07 Mar, 2024 | US8486975 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 16 Feb, 2024 | US8486975 |
| Requirement for information sent under 37 CFR 1.750 | 22 Jan, 2024 | US8486975 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Aug, 2023 | US10603282 |
| transaction for FDA Determination of Regulatory Review Period | 04 Aug, 2023 | US8486975 |
| transaction for FDA Determination of Regulatory Review Period | 14 Jul, 2023 | US8486975 |
| Second letter to regulating agency to determine regulatory review period | 11 May, 2021 | US8486975 |
| Recordation of Patent Grant Mailed Critical | 24 Nov, 2020 | US10842751 |
FDA has granted several exclusivities to Delstrigo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Delstrigo, 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 Delstrigo.
Exclusivity Information
Delstrigo holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Delstrigo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-806) | Sep 19, 2022 |
| New Chemical Entity Exclusivity(NCE) | Aug 30, 2023 |
| New Patient Population(NPP) | Jan 27, 2025 |
US patents provide insights into the exclusivity only within the United States, but Delstrigo 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 Delstrigo's family patents as well as insights into ongoing legal events on those patents.
Delstrigo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Delstrigo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 29, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Delstrigo Generics:
There are no approved generic versions for Delstrigo as of now.
How can I launch a generic of Delstrigo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Delstrigo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Delstrigo'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 Delstrigo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg/300 mg/ 300 mg | 30 Aug, 2022 | 1 | 29 Nov, 2036 |
About Delstrigo
Delstrigo is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is used for treating HIV-1 infection in pediatric patients weighing at least 35kg without prior antiretroviral treatment or replacing current regimen in virologically suppressed patients. Delstrigo uses Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate as an active ingredient. Delstrigo was launched by Msd Merck Co in 2018.
Approval Date:
Delstrigo was approved by FDA for market use on 30 August, 2018.
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 Delstrigo is 30 August, 2018, its NCE-1 date is estimated to be 30 August, 2022.
Active Ingredient:
Delstrigo uses Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate as the active ingredient. Check out other Drugs and Companies using Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate ingredient
Treatment:
Delstrigo is used for treating HIV-1 infection in pediatric patients weighing at least 35kg without prior antiretroviral treatment or replacing current regimen in virologically suppressed patients.
Dosage:
Delstrigo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG;300MG;300MG | TABLET | Prescription | ORAL |