Lidoderm is a drug owned by Teikoku Pharma Usa Inc. It is protected by 2 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 Oct 27, 2015. Details of Lidoderm'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). | |||
| US5827529 | External preparation for application to the skin containing lidocaine |
Oct, 2015
(10 years ago) |
Expired
|
| US5741510 | Adhesive patch for applying analgesic medication to the skin |
Mar, 2014
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Lidoderm 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 Lidoderm's family patents as well as insights into
ongoing legal events
on those patents.
Lidoderm's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Lidoderm:
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:
Lidoderm's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 27, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lidoderm Generic API suppliers:
Lidocaine is the generic name for the brand Lidoderm. 28 different companies have already filed for the generic of Lidoderm, with Carlisle having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lidoderm's generic
How can I launch a generic of Lidoderm before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lidoderm's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lidoderm'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 Lidoderm -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 13 Nov, 2009 | 27 Oct, 2015 | Deferred | 23 Aug, 2012 | Less |
Alternative Brands for Lidoderm
Lidoderm which is used for local pain relief on the skin., 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 |
| |
| Scilex Pharms |
| |
| Thea Pharma |
| |
| Vyteris |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Lidocaine, Lidoderm's active ingredient. Check the complete list of approved generic manufacturers for Lidoderm
About Lidoderm
Lidoderm is a drug owned by Teikoku Pharma Usa Inc. It is used for local pain relief on the skin. Lidoderm uses Lidocaine as an active ingredient. Lidoderm was launched by Teikoku in 1999.
Approval Date:
Lidoderm was approved by FDA for market use on 19 March, 1999.
Active Ingredient:
Lidoderm uses Lidocaine as the active ingredient. Check out other Drugs and Companies using Lidocaine ingredient
Treatment:
Lidoderm is used for local pain relief on the skin.
Dosage:
Lidoderm is available in patch form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% | PATCH | Prescription | TOPICAL |