Aklief is a drug owned by Galderma Laboratories Lp. It is protected by 5 US drug patents filed from 2019 to 2021 out of which none have expired yet. Aklief's patents have been open to challenges since 05 October, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be May 30, 2033. Details of Aklief'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. | |||
| US7807708 | Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof |
Jul, 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). | |||
| US9498465 | Topical compositions in the form of a gel containing a particular solubilized retinoid |
May, 2033
(8 years from now) | Active |
| US9084778 | Topical compositions containing a retinoid of the oil-in-water emulsion type |
May, 2033
(8 years from now) | Active |
| US8470871 | Ligands that modulate RAR receptors |
Dec, 2025
(11 months from now) | Active |
| US8227507 | Ligands that modulate RAR receptors |
Dec, 2025
(11 months 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 Aklief's patents.
Latest Legal Activities on Aklief's Patents
Given below is the list of recent legal activities going on the following patents of Aklief.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 May, 2024 | US9498465 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jan, 2024 | US8227507 |
| Patent Term Extension Certificate Critical | 25 May, 2023 | US7807708 |
| Withdrawal of Application for PTE Critical | 18 May, 2023 | US8227507 |
| Withdrawal of Application for PTE Critical | 18 May, 2023 | US8470871 |
| Notice of Final Determination -Election Required | 13 Apr, 2023 | US7807708 |
| Notice of Final Determination -Election Required | 13 Apr, 2023 | US8227507 |
| Notice of Final Determination -Election Required | 13 Apr, 2023 | US8470871 |
| FDA Final Eligibility Letter Critical | 29 Jul, 2022 | US7807708 |
| FDA Final Eligibility Letter Critical | 29 Jul, 2022 | US8470871 |
FDA has granted several exclusivities to Aklief. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aklief, 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 Aklief.
Exclusivity Information
Aklief holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Aklief's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 04, 2024 |
Several oppositions have been filed on Aklief'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 Aklief's generic, the next section provides detailed information on ongoing and past EP oppositions related to Aklief patents.
Aklief's Oppositions Filed in EPO
Aklief has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 26, 2019, by Generics (Uk) Ltd. This opposition was filed on patent number EP13728696A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13726504A | Apr, 2019 | Generics (U.K.) Limited | Patent maintained as amended |
| EP13728696A | Mar, 2019 | Generics (UK) Ltd | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Aklief 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 Aklief's family patents as well as insights into ongoing legal events on those patents.
Aklief's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aklief's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 30, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aklief Generics:
There are no approved generic versions for Aklief as of now.
Alternative Brands for Aklief
Aklief which is used for treating acne vulgaris by activating RARgamma receptor topically., has several other brand drugs in the same treatment category . 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Almirall |
| |||||||||
| Bausch |
| |||||||||
| Galderma Labs Lp |
| |||||||||
About Aklief
Aklief is a drug owned by Galderma Laboratories Lp. It is used for treating acne vulgaris by activating RARgamma receptor topically. Aklief uses Trifarotene as an active ingredient. Aklief was launched by Galderma Labs Lp in 2019.
Approval Date:
Aklief was approved by FDA for market use on 04 October, 2019.
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 Aklief is 04 October, 2019, its NCE-1 date is estimated to be 05 October, 2023.
Active Ingredient:
Aklief uses Trifarotene as the active ingredient. Check out other Drugs and Companies using Trifarotene ingredient
Treatment:
Aklief is used for treating acne vulgaris by activating RARgamma receptor topically.
Dosage:
Aklief is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.005% | CREAM | Prescription | TOPICAL |