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GRALISE Drug Profile
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When do Gralise patents expire, and when can generic versions of Gralise launch?
Gralise is a drug marketed by Assertio and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-four patent family members in sixteen countries.
The generic ingredient in GRALISE is gabapentin. There are twenty-nine drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
US ANDA Litigation and Generic Entry Outlook for Gralise
A generic version of GRALISE was approved as gabapentin by ACTAVIS ELIZABETH on January 20th, 2020.
Summary for GRALISE
| International Patents: | 54 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 124 |
| Clinical Trials: | 10 |
| Patent Applications: | 5,914 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GRALISE |
| Drug Sales Revenues: | Drug sales revenues for GRALISE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GRALISE |
| DailyMed Link: | GRALISE at DailyMed |
Recent Clinical Trials for GRALISE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Davis | Phase 3 |
| University of Balamand | Phase 4 |
| Roswell Park Cancer Institute | N/A |
Recent Litigation for GRALISE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| In re: Depomed, Inc. | 2015-12-30 |
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
| Purdue Pharma L.P. v. Depomed, Inc. | 2015-09-15 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Endo Pharmaceutical Inc. | 2014-04-17 |
| Purdue Pharma L.P. | 2014-01-24 |
Pharmacology for GRALISE
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for GRALISE
| (1-Aminomethyl-cyclohexyl)-acetic acid |
| [1-(AMINOMETHYL)CYCLOHEXYL]ACETIC ACID |
| 1-(Aminomethyl)-cyclohexaneacetic acid |
| 1-(Aminomethyl)-cyclohexaneacetic acid; Neurontin |
| 1-(aminomethyl)cyclohexanacetic acid |
| 1-(Aminomethyl)cyclohexaneacetic acid |
| 1-(Aminomethyl)cyclohexaneaceticAcid |
| 1-(aminomethyl)cyclohexyl-acetic Acid |
| 1-aminomethyl cyclohexaneacetic acid |
| 1-aminomethyl-1-cyclohexane-acetic acid |
| 1-Aminomethyl-1cyclohexane-acetic acid |
| 2-(1-(aminomethyl)cyclohexyl)acetic acid |
| 2-[(aminomethyl)cyclohexyl]acetic acid |
| 2-[1-(aminomethyl)cyclohexyl]acetic acid |
| 42G963 |
| 60142-96-3 |
| 6CW7F3G59X |
| AB0068842 |
| AB07485 |
| AB1000455 |
| AC-1485 |
| AC1L1FYE |
| AC1Q53PH |
| Aclonium |
| ACT03340 |
| AJ-08236 |
| AKOS000280865 |
| AM20070538 |
| AN-14914 |
| ANW-43124 |
| BBL010794 |
| BCP25698 |
| BDBM50080153 |
| BIDD:GT0656 |
| BPBio1_000993 |
| BR-35803 |
| BRN 2359739 |
| BSPBio_000901 |
| C07018 |
| C9H17NO2 |
| CAS-60142-96-3 |
| CCG-204671 |
| CCRIS 7210 |
| CHEBI:42797 |
| CHEMBL940 |
| CI 945 |
| CI-945 |
| CPD000058311 |
| CS-1545 |
| CTK3J2213 |
| Cyclohexaneacetic acid, 1-(aminomethyl)- |
| D00332 |
| DB00996 |
| DDS-2003 |
| DM-1796 |
| DM-5689 |
| DSSTox_CID_74 |
| DSSTox_GSID_20074 |
| DSSTox_RID_75350 |
| DTXSID0020074 |
| EINECS 262-076-3 |
| EN300-52516 |
| EU-0100582 |
| Fanatrex |
| FT-0626586 |
| G-154 |
| G0318 |
| Gabapen |
| gabapentin |
| Gabapentin (JAN/USAN/INN) |
| gabapentin (Neurontin) |
| Gabapentin [USAN:INN:BAN] |
| Gabapentin [USAN:USP:INN:BAN] |
| Gabapentin GR |
| Gabapentin solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Gabapentin solution, 10 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Gabapentin-ER |
| Gabapentin, European Pharmacopoeia (EP) Reference Standard |
| Gabapentin, Pharmaceutical Secondary Standard; Certified Reference Material |
| Gabapentin, solid |
| Gabapentin, United States Pharmacopeia (USP) Reference Standard |
| GABAPENTIN; NEURONTIN |
| gabapentina |
| Gabapentine |
| Gabapentine [INN-French] |
| gabapentinium |
| Gabapentino |
| Gabapentino [INN-Spanish] |
| Gabapentino [Spanish] |
| Gabapentinum |
| Gabapentinum [INN-Latin] |
| Gabapetin |
| GBN |
| Go 3450 |
| GOE 2450 |
| GOE 3450 |
| GOE 3450; CI 945; GO 3450 |
| Goe-3450 |
| Gralise (TN) |
| GTPL5483 |
| HMS1570N03 |
| HMS2089J03 |
| HMS2097N03 |
| HMS2236O03 |
| HMS3261F06 |
| HMS3650A20 |
| HMS3714N03 |
| HSDB 7364 |
| HY-A0057 |
| I06-0677 |
| KS-00000AF6 |
| KS-1064 |
| KSC492E1H |
| L000733 |
| Lopac-G-154 |
| Lopac0_000582 |
| LP00582 |
| LS-7194 |
| M-2788 |
| MCULE-5392848565 |
| MFCD00865286 |
| MFCD00865286 (98%) |
| MLS000069358 |
| MolPort-000-883-862 |
| NCGC00015466-01 |
| NCGC00015466-02 |
| NCGC00015466-03 |
| NCGC00015466-04 |
| NCGC00015466-05 |
| NCGC00015466-06 |
| NCGC00015466-07 |
| NCGC00015466-08 |
| NCGC00015466-09 |
| NCGC00015466-11 |
| NCGC00016891-01 |
| NCGC00021545-02 |
| NCGC00021545-04 |
| NCGC00021545-05 |
| NCGC00261267-01 |
| Neuontin |
| Neurentin |
| Neurontin |
| Neurontin (TN) |
| Novo-Gabapentin |
| Novo-Gabapentine |
| NSC-742194 |
| NSC742194 |
| Prestwick_151 |
| Prestwick0_000861 |
| Prestwick1_000861 |
| Prestwick2_000861 |
| Prestwick3_000861 |
| RTR-020802 |
| s2133 |
| SAM002548985 |
| SAM002589946 |
| SBB066157 |
| SBI-0206904.P001 |
| SC-12130 |
| SCHEMBL8343 |
| Sefelsa |
| Serada |
| SMR000058311 |
| SPBio_002822 |
| SR-01000000019 |
| SR-01000000019-11 |
| SR-01000000019-2 |
| SR-01000000019-6 |
| ST2410212 |
| STK598009 |
| SY005403 |
| Therapentin-90 |
| TL8003814 |
| Tocris-0806 |
| Tox21_110157 |
| Tox21_110157_1 |
| Tox21_500582 |
| TR-020802 |
| TRA0097671 |
| UGJMXCAKCUNAIE-UHFFFAOYSA-N |
| UNII-6CW7F3G59X |
| Vultin |
| Z1258578343 |
| ZINC4949 |
Paragraph IV (Patent) Challenges for GRALISE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GRALISE | TABLET;ORAL | gabapentin | 022544 | 2011-10-31 |
US Patents and Regulatory Information for GRALISE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GRALISE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | Start Trial | Start Trial |
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | Start Trial | Start Trial |
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | Start Trial | Start Trial |
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GRALISE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2013006863 | Start Trial |
| Australia | 2005267738 | Start Trial |
| Denmark | 1439825 | Start Trial |
| Australia | 2002337974 | Start Trial |
| Japan | 5421511 | Start Trial |
| New Zealand | 523214 | Start Trial |
| China | 101484153 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
