Picato Patent Expiration

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
US9861603 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US8372827 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US9833429 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US8377919 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US8372828 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US9833428 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US8536163 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US8716271 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US9820959 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US8735375 Therapeutic compositions
Dec, 2026

(2 years from now)

Active
US6844013 Methods of stimulating the immune system
Dec, 2018

(5 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.

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

Activity Date Patent Number
Patent litigations
Correspondence Address Change 26 Jun, 2024 US9820959
Correspondence Address Change 26 Jun, 2024 US8716271 (Litigated)
Correspondence Address Change 26 Jun, 2024 US9789078
Correspondence Address Change 26 Jun, 2024 US8536163 (Litigated)
Correspondence Address Change 26 Jun, 2024 US8278292 (Litigated)
Correspondence Address Change 26 Jun, 2024 US8372828 (Litigated)
Correspondence Address Change 26 Jun, 2024 US8372827 (Litigated)
Correspondence Address Change 26 Jun, 2024 US8735375 (Litigated)
Correspondence Address Change 26 Jun, 2024 US8377919 (Litigated)
Correspondence Address Change 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

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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
Patent litigations
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

Picato has patent protection in a total of 21 countries. It's US patent count contributes only to 37.2% of its total global patent coverage. 10 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 Picato.

Family Patents

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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 Generics:

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.

Drug Owner Drug Name Treatment Area
Bausch
Zyclara Used for treating skin conditions caused by certain types of viruses.
Valeant Pharms North
Carac Used for treating actinic keratosis.





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