Ztlido is a drug owned by Scilex Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2018 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 10, 2031. Details of Ztlido'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). | |||
| US11793766 | Non-aqueous patch for the relief of pain |
May, 2031
(4 years from now) | Active |
| US9925264 | Non-aqueous patch |
May, 2031
(4 years from now) | Active |
| US9283174 | Non-aqueous patch |
May, 2031
(4 years from now) | Active |
| US11786455 | Non-aqueous patch |
May, 2031
(4 years from now) | Active |
| US10765749 | Non-aqueous patch |
May, 2031
(4 years from now) | Active |
| US9931403 | Non-aqueous patch |
May, 2031
(4 years from now) | Active |
| US11278623 | Non-aqueous patch |
May, 2031
(4 years from now) | Active |
| US10765640 | Non-aqueous patch |
May, 2031
(4 years from now) | Active |
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 Ztlido's patents.
Latest Legal Activities on Ztlido's Patents
Given below is the list of recent legal activities going on the following patents of Ztlido.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Sep, 2025 | US9931403 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Sep, 2025 | US11278623 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Sep, 2025 | US9925264 |
| Email Notification | 10 Jan, 2025 | US11793766 |
| Change in Power of Attorney (May Include Associate POA) | 10 Jan, 2025 | US10765749 |
| Change in Power of Attorney (May Include Associate POA) | 10 Jan, 2025 | US11278623 |
| Change in Power of Attorney (May Include Associate POA) | 10 Jan, 2025 | US11786455 |
| Email Notification | 10 Jan, 2025 | US11278623 |
| Email Notification | 10 Jan, 2025 | US10765749 |
| Email Notification | 10 Jan, 2025 | US11786455 |
FDA has granted several exclusivities to Ztlido. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Ztlido, 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
Ztlido.
Exclusivity Information
Ztlido holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Ztlido's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 28, 2021 |
US patents provide insights into the exclusivity only within the United States, but
Ztlido 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 Ztlido's family patents as well as insights into
ongoing legal events
on those patents.
Ztlido's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Ztlido:
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.
Generic Launch
Generic Release Date:
Ztlido's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 10, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ztlido Generic API suppliers:
Lidocaine is the generic name for the brand Ztlido. 28 different companies have already filed for the generic of Ztlido, with Carlisle having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ztlido's generic
How can I launch a generic of Ztlido before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ztlido's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ztlido'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 Ztlido -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 17 Mar, 2022 | 10 May, 2031 | Deferred | 25 Mar, 2025 | Less |
Alternative Brands for Ztlido
Ztlido which is used for managing pain associated with post-herpetic neuralgia., has several other brand drugs using the same active ingredient (Lidocaine). 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 | |
|---|---|---|
| Crescita Therap |
| |
| Dentsply Pharm |
| |
| Galen Specialty |
| |
| Medrx Usa |
| |
| Powder Pharms |
| |
| Teikoku Pharma Usa |
| |
| Thea Pharma |
| |
| Vyteris |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Lidocaine, Ztlido's active ingredient. Check the complete list of approved generic manufacturers for Ztlido
About Ztlido
Ztlido is a drug owned by Scilex Pharmaceuticals Inc. It is used for managing pain associated with post-herpetic neuralgia. Ztlido uses Lidocaine as an active ingredient. Ztlido was launched by Scilex in 2018.
Approval Date:
Ztlido was approved by FDA for market use on 28 February, 2018.
Active Ingredient:
Ztlido uses Lidocaine as the active ingredient. Check out other Drugs and Companies using Lidocaine ingredient
Treatment:
Ztlido is used for managing pain associated with post-herpetic neuralgia.
Dosage:
Ztlido is available in patch form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.8% | PATCH | Prescription | TOPICAL |