Carbatrol is a drug owned by Takeda Pharmaceuticals Usa Inc. 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 Jun 15, 2016. Details of Carbatrol'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). | |||
| US5912013 | Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine |
Jun, 2016
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Carbatrol 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 Carbatrol's family patents as well as insights into
ongoing legal events
on those patents.
Carbatrol's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Carbatrol:
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:
Carbatrol's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 15, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Carbatrol Generic API suppliers:
Carbamazepine is the generic name for the brand Carbatrol. 34 different companies have already filed for the generic of Carbatrol, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Carbatrol's generic
How can I launch a generic of Carbatrol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Carbatrol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Carbatrol'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 Carbatrol -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| None | |||||
| 02 Feb, 2006 | 15 Jun, 2016 | Extinguished | Less |
Alternative Brands for Carbatrol
Carbatrol which is used for treating neurological and other disorders such as epilepsy with twice daily oral dosing., has several other brand drugs using the same active ingredient (Carbamazepine). 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 Carbamazepine, Carbatrol's active ingredient. Check the complete list of approved generic manufacturers for Carbatrol
About Carbatrol
Carbatrol is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating neurological and other disorders such as epilepsy with twice daily oral dosing. Carbatrol uses Carbamazepine as an active ingredient. Carbatrol was launched by Takeda in 1997.
Approval Date:
Carbatrol was approved by FDA for market use on 30 September, 1997.
Active Ingredient:
Carbatrol uses Carbamazepine as the active ingredient. Check out other Drugs and Companies using Carbamazepine ingredient
Treatment:
Carbatrol is used for treating neurological and other disorders such as epilepsy with twice daily oral dosing.
Dosage:
Carbatrol is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 300MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 100MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |