Vtama is a drug owned by Dermavant Sciences Inc. It is protected by 11 US drug patents filed from 2022 to 2025 out of which none have expired yet. Vtama's patents will be open to challenges from 23 May, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 13, 2039. Details of Vtama'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. | |||
| US11597692 | Process for preparing tapinarof |
Nov, 2038
(13 years from now) | Active |
| US10647649 | Process for preparing tapinarof |
Nov, 2038
(13 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). | |||
| US11497718 | Use of tapinarof for the treatment of atopic dermatitis |
Nov, 2039
(14 years from now) | Active |
| US11938099 | Use of tapinarof for the treatment of atopic dermatitis |
Nov, 2039
(14 years from now) | Active |
| US11590088 | Use of Tapinarof for the treatment of chronic plaque psoriasis |
Nov, 2039
(14 years from now) | Active |
| US11458108 | Topical pharmaceutical compositions |
May, 2036
(10 years from now) | Active |
| US10426743 | Topical pharmaceutical compositions |
May, 2036
(10 years from now) | Active |
| US11612573 | Topical pharmaceutical compositions |
May, 2036
(10 years from now) | Active |
| US11617724 | Topical pharmaceutical compositions |
May, 2036
(10 years from now) | Active |
| US10195160 | Topical pharmaceutical compositions |
May, 2036
(10 years from now) | Active |
| US11622945 | Topical pharmaceutical compositions |
May, 2036
(10 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 Vtama's patents.
Latest Legal Activities on Vtama's Patents
Given below is the list of recent legal activities going on the following patents of Vtama.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Petition Requesting Trial | 13 May, 2024 | US11590088 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US10195160 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US10195160 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Oct, 2023 | US10647649 |
| Second letter to regulating agency to determine regulatory review period | 30 Sep, 2023 | US10195160 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2023 | US10195160 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Apr, 2023 | US11622945 |
| Recordation of Patent Grant Mailed Critical | 11 Apr, 2023 | US11622945 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Apr, 2023 | US11617724 |
| Recordation of Patent Grant Mailed Critical | 04 Apr, 2023 | US11617724 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vtama and ongoing litigations to help you estimate the early arrival of Vtama generic.
Vtama's Litigations
Vtama been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 23, 2024, against patent number US11590088. The petitioner Encube Ethicals Pvt. Ltd., challenged the validity of this patent, with Dermavant Sciences GmbH et al. as the respondent. Click below to track the latest information on how companies are challenging Vtama's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11590088 | April, 2024 | Pending | Dermavant Sciences GmbH et al. | Encube Ethicals Pvt. Ltd. |
FDA has granted some exclusivities to Vtama. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vtama, 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 Vtama.
Exclusivity Information
Vtama holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Vtama's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 23, 2027 |
| New Indication(I-956) | Dec 12, 2027 |
Several oppositions have been filed on Vtama'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 Vtama's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vtama patents.
Vtama's Oppositions Filed in EPO
Vtama has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 03, 2023, by Sandoz Ag. This opposition was filed on patent number EP16725243A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP16725243A | Feb, 2023 | SANDOZ AG | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Vtama 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 Vtama's family patents as well as insights into ongoing legal events on those patents.
Vtama's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vtama's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 13, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vtama Generics:
There are no approved generic versions for Vtama as of now.
Alternative Brands for Vtama
Vtama which is used for managing plaque psoriasis in adults through topical application., 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.
About Vtama
Vtama is a drug owned by Dermavant Sciences Inc. It is used for managing plaque psoriasis in adults through topical application. Vtama uses Tapinarof as an active ingredient. Vtama was launched by Dermavant Sci in 2022.
Approval Date:
Vtama was approved by FDA for market use on 23 May, 2022.
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 Vtama is 23 May, 2022, its NCE-1 date is estimated to be 23 May, 2026.
Active Ingredient:
Vtama uses Tapinarof as the active ingredient. Check out other Drugs and Companies using Tapinarof ingredient
Treatment:
Vtama is used for managing plaque psoriasis in adults through topical application.
Dosage:
Vtama is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | CREAM | Prescription | TOPICAL |