Picato is a drug owned by Leo Laboratories Ltd. It is protected by 16 US drug patents filed from 2013 to 2018. Out of these, 12 drug patents are active and 4 have expired. Picato's patents have been open to challenges since 24 January, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be May 15, 2033. Details of Picato's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9789078 | Method of topically treating actinic keratosis with ingenol mebutate cycle therapy |
May, 2033
(8 years from now) | Active |
| US8278292 | Therapeutic compositions |
Jul, 2027
(2 years from now) | Active |
| US8735375 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US8536163 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US8716271 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US9833429 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US8377919 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US8372828 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US9833428 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US8372827 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US9820959 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US9861603 | Therapeutic compositions |
Dec, 2026
(1 year, 7 months from now) | Active |
| US6844013 | Methods of stimulating the immune system |
Dec, 2018
(6 years ago) |
Expired
|
| US7410656 | Anti-cancer compounds |
Aug, 2018
(6 years ago) |
Expired
|
| US6787161 | Anti-cancer compounds |
Aug, 2018
(6 years ago) |
Expired
|
| US6432452 | Anti-cancer compounds |
Aug, 2018
(6 years ago) |
Expired
|
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 Picato's patents.
Latest Legal Activities on Picato's Patents
Given below is the list of recent legal activities going on the following patents of Picato.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 26 Jun, 2024 | US9820959 |
| Correspondence Address Change Critical | 26 Jun, 2024 | US8716271 (Litigated) |
| Correspondence Address Change Critical | 26 Jun, 2024 | US9789078 |
| Correspondence Address Change Critical | 26 Jun, 2024 | US8536163 (Litigated) |
| Correspondence Address Change Critical | 26 Jun, 2024 | US8278292 (Litigated) |
| Correspondence Address Change Critical | 26 Jun, 2024 | US8372828 (Litigated) |
| Correspondence Address Change Critical | 26 Jun, 2024 | US8372827 (Litigated) |
| Correspondence Address Change Critical | 26 Jun, 2024 | US8735375 (Litigated) |
| Correspondence Address Change Critical | 26 Jun, 2024 | US8377919 (Litigated) |
| Correspondence Address Change Critical | 26 Jun, 2024 | US9833428 |
FDA has granted several exclusivities to Picato. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Picato, 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 Picato.
Exclusivity Information
Picato holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Picato's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 23, 2017 |
| M(M-169) | Nov 19, 2018 |
Several oppositions have been filed on Picato'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 Picato's generic, the next section provides detailed information on ongoing and past EP oppositions related to Picato patents.
Picato's Oppositions Filed in EPO
Picato has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 11, 2014, by Sandoz Ag. This opposition was filed on patent number EP06820561A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06820561A | Nov, 2014 | Actavis PTC ehf | Revoked |
| EP06820561A | Nov, 2014 | Galenicum Health S.L. | Revoked |
| EP06820561A | Nov, 2014 | Sandoz AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Picato 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 Picato's family patents as well as insights into ongoing legal events on those patents.
Picato's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Picato's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Picato Generic API suppliers:
Ingenol Mebutate is the generic name for the brand Picato. 1 company has already filed for the generic of Picato. Check out the entire list of companies who have already received approval for Picato's generic
How can I launch a generic of Picato before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Picato's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Picato's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Picato -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 27 Jan, 2016 | 2 | 09 Jan, 2019 | 06 Jul, 2027 | Eligible |
| 0.00015 | 27 Jan, 2016 | 2 | 07 Jan, 2019 | 06 Jul, 2027 | Eligible |
Alternative Brands for Picato
Picato which is used for treating actinic keratosis by inhibiting proliferative activity of neoplastic cells and stimulating the immune system., 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 Picato
Picato is a drug owned by Leo Laboratories Ltd. It is used for treating actinic keratosis by inhibiting proliferative activity of neoplastic cells and stimulating the immune system. Picato uses Ingenol Mebutate as an active ingredient. Picato was launched by Leo Labs in 2012.
Approval Date:
Picato was approved by FDA for market use on 23 January, 2012.
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 Picato is 23 January, 2012, its NCE-1 date is estimated to be 24 January, 2016.
Active Ingredient:
Picato uses Ingenol Mebutate as the active ingredient. Check out other Drugs and Companies using Ingenol Mebutate ingredient
Treatment:
Picato is used for treating actinic keratosis by inhibiting proliferative activity of neoplastic cells and stimulating the immune system.
Dosage:
Picato is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.015% | GEL | Discontinued | TOPICAL |
| 0.05% | GEL | Discontinued | TOPICAL |