Neurontin is a drug owned by Viatris Specialty Llc. It is protected by 4 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 Nov 28, 2022. Details of Neurontin'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). | |||
|
US7256216 (Pediatric) | Liquid pharmaceutical compositions |
Nov, 2022
(2 years ago) |
Expired
|
| US7256216 | Liquid pharmaceutical compositions |
May, 2022
(2 years ago) |
Expired
|
|
US6054482 (Pediatric) | Lactam-free amino acids |
Oct, 2017
(7 years ago) |
Expired
|
| US6054482 | Lactam-free amino acids |
Apr, 2017
(8 years ago) |
Expired
|
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 Neurontin's patents.
Latest Legal Activities on Neurontin's Patents
Given below is the list of recent legal activities going on the following patents of Neurontin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 17 Aug, 2021 | US7256216 |
| Email Notification Critical | 17 Aug, 2021 | US7256216 |
| Correspondence Address Change Critical | 16 Aug, 2021 | US7256216 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jan, 2019 | US7256216 |
| Recordation of Patent Grant Mailed Critical | 14 Aug, 2007 | US7256216 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Aug, 2007 | US7256216 |
| Issue Notification Mailed Critical | 25 Jul, 2007 | US7256216 |
| Dispatch to FDC | 09 Jul, 2007 | US7256216 |
| Application Is Considered Ready for Issue Critical | 09 Jul, 2007 | US7256216 |
| Workflow - Request for RCE - Finish | 09 Jul, 2007 | US7256216 |
US patents provide insights into the exclusivity only within the United States, but Neurontin 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 Neurontin's family patents as well as insights into ongoing legal events on those patents.
Neurontin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Neurontin's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 28, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Neurontin Generic API suppliers:
Gabapentin is the generic name for the brand Neurontin. 46 different companies have already filed for the generic of Neurontin, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Neurontin's generic
How can I launch a generic of Neurontin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Neurontin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Neurontin'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 Neurontin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg, 300 mg and 400 mg | |||||
| 100 mg, 300 mg and 400 mg | |||||
| 250 mg/5 mL | |||||
| 600 mg and 800 mg |
Alternative Brands for Neurontin
There are several other brand drugs using the same active ingredient (Gabapentin) as Neurontin. 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 Gabapentin, Neurontin's active ingredient. Check the complete list of approved generic manufacturers for Neurontin
About Neurontin
Neurontin is a drug owned by Viatris Specialty Llc. Neurontin uses Gabapentin as an active ingredient. Neurontin was launched by Viatris in 2000.
Approval Date:
Neurontin was approved by FDA for market use on 02 March, 2000.
Active Ingredient:
Neurontin uses Gabapentin as the active ingredient. Check out other Drugs and Companies using Gabapentin ingredient
Dosage:
Neurontin is available in the following dosage forms - capsule form for oral use, solution form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/5ML | SOLUTION | Prescription | ORAL |
| 300MG | CAPSULE | Prescription | ORAL |
| 400MG | CAPSULE | Prescription | ORAL |
| 600MG | TABLET | Prescription | ORAL |
| 800MG | TABLET | Prescription | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |