Diastat Acudial 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 Acudial'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 Acudial 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 Acudial's family patents as well as insights into ongoing legal events on those patents.
Diastat Acudial's Family Patents
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Generic Launch
Generic Release Date:
Diastat Acudial'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 Acudial Generic API suppliers:
Diazepam is the generic name for the brand Diastat Acudial. 34 different companies have already filed for the generic of Diastat Acudial, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Diastat Acudial's generic
How can I launch a generic of Diastat Acudial before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Diastat Acudial's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Diastat Acudial'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 Acudial -
| 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 Acudial
There are several other brand drugs using the same active ingredient (Diazepam) as Diastat Acudial. 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 Diazepam, Diastat Acudial's active ingredient. Check the complete list of approved generic manufacturers for Diastat Acudial
About Diastat Acudial
Diastat Acudial is a drug owned by Bausch Health Us Llc. Diastat Acudial uses Diazepam as an active ingredient. Diastat Acudial was launched by Bausch in 1997.
Approval Date:
Diastat Acudial was approved by FDA for market use on 29 July, 1997.
Active Ingredient:
Diastat Acudial uses Diazepam as the active ingredient. Check out other Drugs and Companies using Diazepam ingredient
Dosage:
Diastat Acudial is available in gel form for rectal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG/4ML (5MG/ML) | GEL | Prescription | RECTAL |
| 10MG/2ML (5MG/ML) | GEL | Prescription | RECTAL |