Protopic is a drug owned by Leo Pharma As. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 09, 2014. Details of Protopic'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). | |||
| US5665727 | Use of 11,28-dioxa-4-azatricyclo[22.3.1.04,9 ]octacos-18-ene derivatives and pharmaceutical compositions containing them |
Sep, 2014
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Protopic 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 Protopic's family patents as well as insights into
ongoing legal events
on those patents.
Protopic's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Protopic:
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:
Protopic's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 09, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Protopic Generic API suppliers:
Tacrolimus is the generic name for the brand Protopic. 18 different companies have already filed for the generic of Protopic, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Protopic's generic
How can I launch a generic of Protopic before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Protopic's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Protopic'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 Protopic -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 22 Nov, 2010 | 09 Sep, 2014 | Extinguished | 09 Sep, 2014 | Less | |
| 09 Sep, 2010 | 09 Sep, 2014 | Extinguished | 09 Sep, 2014 | Less |
Alternative Brands for Protopic
Protopic which is used for treating dermatitis., has several other brand drugs using the same active ingredient (Tacrolimus). 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 | |
|---|---|---|
| Astellas |
| |
| Veloxis Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tacrolimus, Protopic's active ingredient. Check the complete list of approved generic manufacturers for Protopic
About Protopic
Protopic is a drug owned by Leo Pharma As. It is used for treating dermatitis. Protopic uses Tacrolimus as an active ingredient. Protopic was launched by Leo in 2000.
Approval Date:
Protopic was approved by FDA for market use on 08 December, 2000.
Active Ingredient:
Protopic uses Tacrolimus as the active ingredient. Check out other Drugs and Companies using Tacrolimus ingredient
Treatment:
Protopic is used for treating dermatitis.
Dosage:
Protopic is available in ointment form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.03% | OINTMENT | Prescription | TOPICAL |
| 0.1% | OINTMENT | Prescription | TOPICAL |