Pifeltro is a drug owned by Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. It is protected by 1 US drug patent filed in 2018 out of which none have expired yet. Pifeltro'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 Aug 30, 2032. Details of Pifeltro'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 |
Aug, 2032
(7 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 Pifeltro's patents.
Latest Legal Activities on Pifeltro's Patents
Given below is the list of recent legal activities going on the following patents of Pifeltro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 |
| 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 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8486975 |
| Letter from FDA or Dept of Agriculture re PTE application | 29 Nov, 2019 | US8486975 |
| Initial letter Re: PTE Application to regulating agency | 04 Jun, 2019 | US8486975 |
FDA has granted several exclusivities to Pifeltro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pifeltro, 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 Pifeltro.
Exclusivity Information
Pifeltro holds 3 exclusivities. All of its exclusivities have expired in 2025. Details of Pifeltro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-827) | 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 Pifeltro 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 Pifeltro's family patents as well as insights into ongoing legal events on those patents.
Pifeltro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pifeltro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 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)
Pifeltro Generics:
There are no approved generic versions for Pifeltro as of now.
Alternative Brands for Pifeltro
Pifeltro which is used for treating HIV-1 infection in pediatric patients., has several other brand drugs using the same active ingredient (Doravirine). 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 | |
|---|---|---|
| Msd Merck Co |
|
About Pifeltro
Pifeltro 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. Pifeltro uses Doravirine as an active ingredient. Pifeltro was launched by Msd Merck Co in 2018.
Approval Date:
Pifeltro 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 Pifeltro is 30 August, 2018, its NCE-1 date is estimated to be 30 August, 2022.
Active Ingredient:
Pifeltro uses Doravirine as the active ingredient. Check out other Drugs and Companies using Doravirine ingredient
Treatment:
Pifeltro is used for treating HIV-1 infection in pediatric patients.
Dosage:
Pifeltro is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |