Retin-a Micro is a drug owned by Bausch Health Us Llc. 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 21, 2016. Details of Retin-a Micro'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). | |||
| US5955109 | Methods and compositions for topical delivery of retinoic acid |
Sep, 2016
(8 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Retin-a Micro and ongoing litigations to help you estimate the early arrival of Retin-a Micro generic.
Retin-a Micro's Litigations
Retin-a Micro been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 26, 1995, against patent number US5955109. The petitioner , challenged the validity of this patent, with WON et al as the respondent. Click below to track the latest information on how companies are challenging Retin-a Micro's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5955109 | September, 1995 |
Decision
(18 Sep, 1997) | WON et al | |
US patents provide insights into the exclusivity only within the United States, but Retin-a Micro 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 Retin-a Micro's family patents as well as insights into ongoing legal events on those patents.
Retin-a Micro's Family Patents
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Generic Launch
Generic Release Date:
Retin-a Micro's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 21, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Retin-a Micro Generic API suppliers:
Tretinoin is the generic name for the brand Retin-a Micro. 14 different companies have already filed for the generic of Retin-a Micro, with Padagis Us having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Retin-a Micro's generic
How can I launch a generic of Retin-a Micro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Retin-a Micro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Retin-a Micro'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 Retin-a Micro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0004 | 20 Dec, 2010 | 1 | 17 Jul, 2013 | 21 Sep, 2016 | Eligible |
| 0.001 | 08 Jul, 2010 | 1 | 17 Jul, 2013 | 21 Sep, 2016 | Eligible |
Alternative Brands for Retin-a Micro
Retin-a Micro which is used for treating acne vulgaris., has several other brand drugs in the same treatment category and using the same active ingredient (Tretinoin). 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 | Treatment Area | ||
|---|---|---|---|---|
| Bausch |
| |||
| Galderma Labs Lp |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Tretinoin. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Almirall |
| ||
| Bausch |
| ||
| Concordia |
| ||
| Dow Pharm |
| ||
| Galderma Labs Lp |
| ||
| Sun Pharm |
| ||
| Sun Pharm Inds Inc |
| ||
| Valeant Pharms North |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tretinoin, Retin-a Micro's active ingredient. Check the complete list of approved generic manufacturers for Retin-a Micro
About Retin-a Micro
Retin-A Micro is a drug owned by Bausch Health Us Llc. It is used for treating acne vulgaris. Retin-A Micro uses Tretinoin as an active ingredient. Retin-A Micro was launched by Bausch in 2002.
Approval Date:
Retin-a Micro was approved by FDA for market use on 10 May, 2002.
Active Ingredient:
Retin-a Micro uses Tretinoin as the active ingredient. Check out other Drugs and Companies using Tretinoin ingredient
Treatment:
Retin-a Micro is used for treating acne vulgaris.
Dosage:
Retin-a Micro is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1% | GEL | Prescription | TOPICAL |
| 0.04% | GEL | Prescription | TOPICAL |