Tapinarof Patent Expiration
Tapinarof is Used for managing plaque psoriasis in adults through topical application. It was first introduced by Organon Llc
Tapinarof Patents
Given below is the list of patents protecting Tapinarof, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Vtama | US12569453 | Use Of Tapinarof For The Treatment Of Atopic Dermatitis | Dec 18, 2039 | Organon Llc |
| Vtama | US11497718 | Use of tapinarof for the treatment of atopic dermatitis | Nov 13, 2039 | Organon Llc |
| Vtama | US11590088 | Use of Tapinarof for the treatment of chronic plaque psoriasis | Nov 13, 2039 | Organon Llc |
| Vtama | US11938099 | Use of tapinarof for the treatment of atopic dermatitis | Nov 13, 2039 | Organon Llc |
| Vtama | US10647649 | Process for preparing tapinarof | Nov 13, 2038 | Organon Llc |
| Vtama | US11597692 | Process for preparing tapinarof | Nov 13, 2038 | Organon Llc |
| Vtama | US10195160 | Topical pharmaceutical compositions | May 23, 2036 | Organon Llc |
| Vtama | US10426743 | Topical pharmaceutical compositions | May 19, 2036 | Organon Llc |
| Vtama | US11458108 | Topical pharmaceutical compositions | May 19, 2036 | Organon Llc |
| Vtama | US11612573 | Topical pharmaceutical compositions | May 19, 2036 | Organon Llc |
| Vtama | US11617724 | Topical pharmaceutical compositions | May 19, 2036 | Organon Llc |
| Vtama | US11622945 | Topical pharmaceutical compositions | May 19, 2036 | Organon Llc |
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 Tapinarof's patents.
Latest Legal Activities on Tapinarof's Patents
Given below is the list recent legal activities going on the following patents of Tapinarof.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Review Certificate Mailed | 17 Jul, 2025 | US11590088 |
| Notice of Final Determination -Eligible | 27 Jun, 2025 | US10195160 |
| FDA Final Eligibility Letter | 10 Jun, 2025 | US10195160 |
| Information Disclosure Statement (IDS) Filed | 10 Jun, 2025 | US10195160 |
| Review Certificate | 12 May, 2025 | US11590088 |
| Post Issue Communication - Dedicate Life of Patent to Public/Disclaimers | 13 Mar, 2025 | US11590088 |
| Termination or Final Written Decision | 07 Mar, 2025 | US11590088 |
| Request for Trial Granted | 08 Nov, 2024 | US11590088 |
| Petition Requesting Trial | 13 May, 2024 | US11590088 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US10195160 |
Tapinarof's Family Patents
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Clinical Trials
Recent Clinical Trials on Tapinarof:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis | Organon and Co | NA |
ACTIVE NOT RECRUITING
(Aug 1, 2026)
| PHASE3 |
| Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma | Indiana University | NA |
ACTIVE NOT RECRUITING
(Jun 1, 2026)
| PHASE2 |
| A Study Comparing Tapinarof Cream 1% and Vtama® Cream 1% in the Treatment of Plaque Psoriasis. | Sun Pharmaceutical Industries, Inc. | NA |
COMPLETED
(Apr 1, 2026)
| PHASE1 |