Vtama Patent Expiration

Vtama is a drug owned by Dermavant Sciences Inc. It is protected by 9 US drug patents filed from 2022 to 2023 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.
US10647649 Process for preparing tapinarof
Nov, 2038

(14 years from now)

Active
US11597692 Process for preparing tapinarof
Nov, 2038

(14 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).
US11590088 Use of Tapinarof for the treatment of chronic plaque psoriasis
Nov, 2039

(15 years from now)

Active
US11617724 Topical pharmaceutical compositions
May, 2036

(11 years from now)

Active
US10195160 Topical pharmaceutical compositions
May, 2036

(11 years from now)

Active
US11622945 Topical pharmaceutical compositions
May, 2036

(11 years from now)

Active
US11458108 Topical pharmaceutical compositions
May, 2036

(11 years from now)

Active
US11612573 Topical pharmaceutical compositions
May, 2036

(11 years from now)

Active
US10426743 Topical pharmaceutical compositions
May, 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 Vtama's patents.

Given below is the list of recent legal activities going on the following patents of Vtama.

Activity Date Patent Number
Patent litigations
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 11 Apr, 2023 US11622945
Recordation of Patent Grant Mailed 11 Apr, 2023 US11622945
Patent Issue Date Used in PTA Calculation 04 Apr, 2023 US11617724
Recordation of Patent Grant Mailed 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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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 1 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

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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
Patent litigations
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

Vtama has patent protection in a total of 37 countries. It's US patent count contributes only to 28.8% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Vtama.

Family Patents

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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.

Drug Owner Drug Name Treatment Area
Bausch
Bryhali Used for treating plaque psoriasis in adults.
Duobrii Used for treating plaque psoriasis in adults.





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


Vtama News

Organon expands its presence in the dermatology sector through the acquisition of Roivant's dermatology subsidiary

18 Sep, 2024

Organon to acquire Dermavant and its steroid-free skin cream Vtama for a sum up to $1.2B

18 Sep, 2024

See More