Niravam is a drug owned by Ucb 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 Apr 09, 2018. Details of Niravam'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). | |||
| US6221392 | Rapidly dissolving robust dosage form |
Apr, 2018
(8 years ago) |
Expired
|
| US6024981 | Rapidly dissolving robust dosage form |
Apr, 2018
(8 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Niravam 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 Niravam's family patents as well as insights into
ongoing legal events
on those patents.
Niravam's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Niravam:
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:
Niravam's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 09, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Niravam Generic API suppliers:
Alprazolam is the generic name for the brand Niravam. 25 different companies have already filed for the generic of Niravam, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Niravam's generic
How can I launch a generic of Niravam before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Niravam's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Niravam'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 Niravam -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 27 Dec, 2005 | 09 Apr, 2018 | Extinguished Eligible | 09 Jan, 2009 | Less |
About Niravam
Niravam is a drug owned by Ucb Inc. Niravam uses Alprazolam as an active ingredient. Niravam was launched by Ucb in 2005.
Approval Date:
Niravam was approved by FDA for market use on 19 January, 2005.
Active Ingredient:
Niravam uses Alprazolam as the active ingredient. Check out other Drugs and Companies using Alprazolam ingredient
Dosage:
Niravam is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |