Lexapro is a drug owned by Abbvie Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 12, 2026. Details of Lexapro'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). | |||
|
US7420069 (Pediatric) | Crystalline composition containing escitalopram |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
|
US6916941 (Pediatric) | Crystalline composition containing escitalopram |
Feb, 2023
(1 year, 9 months ago) |
Expired
|
| US6916941 | Crystalline composition containing escitalopram |
Aug, 2022
(2 years ago) |
Expired
|
| US7420069 | Crystalline composition containing escitalopram |
Aug, 2022
(2 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 Lexapro's patents.
Latest Legal Activities on Lexapro's Patents
Given below is the list of recent legal activities going on the following patents of Lexapro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Feb, 2020 | US7420069 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 02 Sep, 2008 | US7420069 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 02 Sep, 2008 | US7420069 (Litigated) |
| Issue Notification Mailed Critical | 13 Aug, 2008 | US7420069 (Litigated) |
| Dispatch to FDC | 05 Aug, 2008 | US7420069 (Litigated) |
| Application Is Considered Ready for Issue Critical | 01 Aug, 2008 | US7420069 (Litigated) |
| Issue Fee Payment Verified Critical | 31 Jul, 2008 | US7420069 (Litigated) |
| Issue Fee Payment Received Critical | 31 Jul, 2008 | US7420069 (Litigated) |
| Response to Reasons for Allowance | 31 Jul, 2008 | US7420069 (Litigated) |
| Mail Examiner's Amendment | 21 May, 2008 | US7420069 (Litigated) |
FDA has granted several exclusivities to Lexapro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lexapro, 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 Lexapro.
Exclusivity Information
Lexapro holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Lexapro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | May 12, 2026 |
Several oppositions have been filed on Lexapro'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 Lexapro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lexapro patents.
Lexapro's Oppositions Filed in EPO
Lexapro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 11, 2005, by Egis Gyogyszergyar Rt.. This opposition was filed on patent number EP02750846A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP04029282A | Oct, 2007 | Ratiopharm GmbH | Revoked |
| EP04029282A | Oct, 2007 | Krka, Tovarna Zdravil, d.d. | Revoked |
| EP04029282A | Oct, 2007 | Generics [UK] Limited | Revoked |
| EP04029282A | Oct, 2007 | Actavis Group hf | Revoked |
| EP04029282A | Oct, 2007 | EGIS Gyógyszergyár Nyrt | Revoked |
| EP04029282A | Sep, 2007 | Pliva Hrvatska D.O.O. | Revoked |
| EP04029282A | Jan, 2007 | SANDOZ AG | Revoked |
| EP02750846A | Oct, 2005 | Egis Gyogyszergyar RT. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Lexapro 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 Lexapro's family patents as well as insights into ongoing legal events on those patents.
Lexapro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lexapro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 12, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lexapro Generic API suppliers:
Escitalopram Oxalate is the generic name for the brand Lexapro. 20 different companies have already filed for the generic of Lexapro, with Macleods Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lexapro's generic
How can I launch a generic of Lexapro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lexapro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lexapro'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 Lexapro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg | 17 Aug, 2005 | 1 | 03 Aug, 2007 | 25 Jul, 2022 | Eligible |
| 10 mg and 20 mg | 30 Mar, 2005 | 1 | 03 Aug, 2007 | 25 Jul, 2022 | Eligible |
| 5 mg, 10 mg and 20 mg |
About Lexapro
Lexapro is a drug owned by Abbvie Inc. Lexapro uses Escitalopram Oxalate as an active ingredient. Lexapro was launched by Abbvie in 2002.
Approval Date:
Lexapro was approved by FDA for market use on 14 August, 2002.
Active Ingredient:
Lexapro uses Escitalopram Oxalate as the active ingredient. Check out other Drugs and Companies using Escitalopram Oxalate ingredient
Dosage:
Lexapro is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |