Lastacaft is a drug owned by Abbvie Inc. It is protected by 3 US drug patents filed from 2013 to 2020. Out of these, 2 drug patents are active and 1 has expired. Lastacaft's patents have been open to challenges since 28 July, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 23, 2027. Details of Lastacaft'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). | |||
| US8664215 | Ocular allergy treatments with alcaftadine |
Dec, 2027
(3 years from now) | Active |
| US10617695 | Ophthalmic compositions containing alcaftadine |
Mar, 2027
(2 years from now) | Active |
| US5468743 | Imidazo[2,1-b]benzazepine derivatives, compositions and method of use |
Nov, 2013
(10 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 Lastacaft's patents.
Latest Legal Activities on Lastacaft's Patents
Given below is the list of recent legal activities going on the following patents of Lastacaft.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Sep, 2023 | US10617695 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Sep, 2021 | US8664215 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 14 Apr, 2020 | US10617695 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Apr, 2020 | US10617695 |
| Email Notification Critical | 26 Mar, 2020 | US10617695 |
| Issue Notification Mailed Critical | 25 Mar, 2020 | US10617695 |
| Dispatch to FDC | 17 Mar, 2020 | US10617695 |
| Application Is Considered Ready for Issue Critical | 17 Mar, 2020 | US10617695 |
| Email Notification Critical | 10 Mar, 2020 | US10617695 |
| Filing Receipt - Corrected | 10 Mar, 2020 | US10617695 |
FDA has granted several exclusivities to Lastacaft. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lastacaft, 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 Lastacaft.
Exclusivity Information
Lastacaft holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Lastacaft's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 28, 2015 |
US patents provide insights into the exclusivity only within the United States, but Lastacaft 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 Lastacaft's family patents as well as insights into ongoing legal events on those patents.
Lastacaft's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lastacaft's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 23, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lastacaft Generic API suppliers:
Alcaftadine is the generic name for the brand Lastacaft. 3 different companies have already filed for the generic of Lastacaft, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lastacaft's generic
How can I launch a generic of Lastacaft before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lastacaft's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lastacaft'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 Lastacaft -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0025 | 30 Jul, 2014 | 1 | 05 Oct, 2029 | Extinguished |
About Lastacaft
Lastacaft is a drug owned by Abbvie Inc. It is used for temporarily relieving itchy eyes caused by allergens such as pollen, ragweed, grass, animal hair, and dander. Lastacaft uses Alcaftadine as an active ingredient. Lastacaft was launched by Abbvie in 2010.
Approval Date:
Lastacaft was approved by FDA for market use on 28 July, 2010.
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 Lastacaft is 28 July, 2010, its NCE-1 date is estimated to be 28 July, 2014.
Active Ingredient:
Lastacaft uses Alcaftadine as the active ingredient. Check out other Drugs and Companies using Alcaftadine ingredient
Treatment:
Lastacaft is used for temporarily relieving itchy eyes caused by allergens such as pollen, ragweed, grass, animal hair, and dander.
Dosage:
Lastacaft is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.25% | SOLUTION/DROPS | Over the counter | OPHTHALMIC |