Ozobax is a drug owned by Metacel Pharmaceuticals Llc. It is protected by 1 US drug patent filed in 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 30, 2039. Details of Ozobax'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). | |||
| US10610502 | Oral baclofen solutions |
Aug, 2039
(14 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 Ozobax's patents.
Latest Legal Activities on Ozobax's Patents
Given below is the list of recent legal activities going on the following patents of Ozobax.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Surcharge for late Payment, Small Entity | 08 Nov, 2023 | US10610502 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 08 Nov, 2023 | US10610502 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Apr, 2020 | US10610502 |
| Application ready for PDX access by participating foreign offices Critical | 07 Apr, 2020 | US10610502 |
| Recordation of Patent Grant Mailed Critical | 07 Apr, 2020 | US10610502 |
| Email Notification Critical | 19 Mar, 2020 | US10610502 |
| Issue Notification Mailed Critical | 18 Mar, 2020 | US10610502 |
| Email Notification Critical | 16 Mar, 2020 | US10610502 |
| Mail Response to 312 Amendment (PTO-271) Critical | 16 Mar, 2020 | US10610502 |
| Printer Rush- No mailing | 16 Mar, 2020 | US10610502 |
US patents provide insights into the exclusivity only within the United States, but Ozobax 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 Ozobax's family patents as well as insights into ongoing legal events on those patents.
Ozobax's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ozobax's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 30, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ozobax Generic API suppliers:
Baclofen is the generic name for the brand Ozobax. 34 different companies have already filed for the generic of Ozobax, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ozobax's generic
How can I launch a generic of Ozobax before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ozobax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ozobax'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 Ozobax -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/5 mL | 26 Jul, 2021 | 1 | 30 Aug, 2039 |
Alternative Brands for Ozobax
Ozobax which is used for managing spasticity., has several other brand drugs using the same active ingredient (Baclofen). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Baclofen, Ozobax's active ingredient. Check the complete list of approved generic manufacturers for Ozobax
About Ozobax
Ozobax is a drug owned by Metacel Pharmaceuticals Llc. It is used for managing spasticity. Ozobax uses Baclofen as an active ingredient. Ozobax was launched by Metacel Pharms Llc in 2019.
Approval Date:
Ozobax was approved by FDA for market use on 18 September, 2019.
Active Ingredient:
Ozobax uses Baclofen as the active ingredient. Check out other Drugs and Companies using Baclofen ingredient
Treatment:
Ozobax is used for managing spasticity.
Dosage:
Ozobax is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/5ML | SOLUTION | Discontinued | ORAL |