Gralise is a drug owned by Almatica Pharma Inc. It is protected by 9 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 Feb 26, 2024. Details of Gralise'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). | |||
| US7438927 | Methods of treatment using a gastric retained gabapentin dosage |
Feb, 2024
(8 months ago) |
Expired
|
| US8192756 | Gastric retained gabapentin dosage form |
Oct, 2022
(2 years ago) |
Expired
|
| US8252332 | Gastric retained gabapentin dosage form |
Oct, 2022
(2 years ago) |
Expired
|
| US7731989 | Gastric retained gabapentin dosage form |
Oct, 2022
(2 years ago) |
Expired
|
| US8333992 | Gastric retained gabapentin dosage form |
Oct, 2022
(2 years ago) |
Expired
|
| US6723340 | Optimal polymer mixtures for gastric retentive tablets |
Oct, 2021
(3 years ago) |
Expired
|
| US6488962 | Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms |
Jun, 2020
(4 years ago) |
Expired
|
| US6340475 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(8 years ago) |
Expired
|
| US6635280 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(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 Gralise's patents.
Latest Legal Activities on Gralise's Patents
Given below is the list of recent legal activities going on the following patents of Gralise.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 08 Jul, 2024 | US8192756 |
| Maintenance Fee Reminder Mailed Critical | 15 Apr, 2024 | US8252332 |
| Maintenance Fee Reminder Mailed Critical | 22 Jan, 2024 | US8192756 |
| Expire Patent Critical | 11 Jul, 2022 | US7731989 |
| Maintenance Fee Reminder Mailed Critical | 24 Jan, 2022 | US7731989 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Jun, 2020 | US8333992 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Apr, 2020 | US7438927 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Feb, 2020 | US8252332 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 05 Dec, 2019 | US8192756 |
| Review Certificate Mailed | 26 Jul, 2018 | US6723340 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Gralise and ongoing litigations to help you estimate the early arrival of Gralise generic.
Gralise's Litigations
Gralise been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 17, 2014, against patent number US6723340. The petitioner Endo Pharmaceutical Inc. et al., challenged the validity of this patent, with DepoMed, Inc. as the respondent. Click below to track the latest information on how companies are challenging Gralise's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6340475 | April, 2014 |
Final Written Decision
(21 Sep, 2015) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6635280 | April, 2014 |
Final Written Decision
(21 Sep, 2015) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6723340 | April, 2014 |
Final Written Decision
(16 Sep, 2015) | DepoMed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6340475 | January, 2014 |
FWD Entered
(08 Jul, 2015) | Depomed, Inc. | Purdue Pharma L.P. |
| US6635280 | January, 2014 |
FWD Entered
(08 Jul, 2015) | DepoMed, Inc. | Purdue Pharma L.P. |
| US6340475 | April, 2014 |
Institution Denied
(29 Sep, 2014) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6635280 | April, 2014 |
Institution Denied
(29 Sep, 2014) | Depomed, Inc. | Endo Pharmaceutical Inc. et al. |
| US6723340 | April, 2014 |
Institution Denied
(29 Sep, 2014) | DepoMed, Inc. | Endo Pharmaceutical Inc. et al. |
FDA has granted some exclusivities to Gralise. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gralise, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gralise.
Exclusivity Information
Gralise holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Gralise's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jan 28, 2014 |
| Orphan Drug Exclusivity(ODE) | Jan 28, 2018 |
| Orphan Drug Exclusivity(ODE-6) | Jan 28, 2018 |
Several oppositions have been filed on Gralise's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Gralise's generic, the next section provides detailed information on ongoing and past EP oppositions related to Gralise patents.
Gralise's Oppositions Filed in EPO
Gralise has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 03, 2014, by Purdue Pharma Lp. This opposition was filed on patent number EP02781665A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP02781665A | Jan, 2014 | Purdue Pharma LP | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Gralise 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 Gralise's family patents as well as insights into ongoing legal events on those patents.
Gralise's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gralise's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 26, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gralise Generic API suppliers:
Gabapentin is the generic name for the brand Gralise. 46 different companies have already filed for the generic of Gralise, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gralise's generic
How can I launch a generic of Gralise before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gralise's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gralise'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 Gralise -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg and 600 mg | 31 Oct, 2011 | 1 | 26 Feb, 2024 |
Alternative Brands for Gralise
Gralise which is used for managing neuropathic pain, including postherpetic neuralgia, with the medication gabapentin., has several other brand drugs using the same active ingredient (Gabapentin). 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, Gralise's active ingredient. Check the complete list of approved generic manufacturers for Gralise
About Gralise
Gralise is a drug owned by Almatica Pharma Inc. It is used for managing neuropathic pain, including postherpetic neuralgia, with the medication gabapentin. Gralise uses Gabapentin as an active ingredient. Gralise was launched by Almatica in 2011.
Approval Date:
Gralise was approved by FDA for market use on 28 January, 2011.
Active Ingredient:
Gralise uses Gabapentin as the active ingredient. Check out other Drugs and Companies using Gabapentin ingredient
Treatment:
Gralise is used for managing neuropathic pain, including postherpetic neuralgia, with the medication gabapentin.
Dosage:
Gralise is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG | TABLET | Prescription | ORAL |
| 300MG | TABLET | Prescription | ORAL |