Diastat 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 17, 2013. Details of Diastat'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). | |||
| US5462740 | Rectally-administered, epileptic-seizure-inhibiting composition |
Sep, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Diastat 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 Diastat's family patents as well as insights into ongoing legal events on those patents.
Diastat's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Diastat's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 17, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Diastat Generic API suppliers:
Diazepam is the generic name for the brand Diastat. 34 different companies have already filed for the generic of Diastat, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Diastat's generic
How can I launch a generic of Diastat before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Diastat's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Diastat'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 Diastat -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL 15 mg/3 mL 20 mg/4 mL | 23 Mar, 2004 | 1 | 31 Oct, 2012 | Extinguished | |
| 5 mg/mL, 4mL pre- filled syringe | 08 Dec, 2008 | 1 | 17 Sep, 2013 | Extinguished | |
| 5 mg/mL, 2mL pre-filled syringe | 23 Dec, 2008 | 1 | 17 Sep, 2013 | Extinguished |
Alternative Brands for Diastat
There are several other brand drugs using the same active ingredient (Diazepam) as Diastat. 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 | |
|---|---|---|
| Aquestive |
| |
| Bausch |
| |
| Neurelis Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diazepam, Diastat's active ingredient. Check the complete list of approved generic manufacturers for Diastat
About Diastat
Diastat is a drug owned by Bausch Health Us Llc. Diastat uses Diazepam as an active ingredient. Diastat was launched by Bausch in 1997.
Approval Date:
Diastat was approved by FDA for market use on 29 July, 1997.
Active Ingredient:
Diastat uses Diazepam as the active ingredient. Check out other Drugs and Companies using Diazepam ingredient
Dosage:
Diastat is available in gel form for rectal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | RECTAL |
| 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | RECTAL |
| 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | RECTAL |
| 2.5MG/0.5ML (5MG/ML) | GEL | Prescription | RECTAL |
| 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | RECTAL |