DrugPatentWatch Database Preview
GRALISE Drug Profile
When do Gralise patents expire, and when can generic versions of Gralise launch?
This drug has fifty-four patent family members in sixteen countries.
The generic ingredient in GRALISE is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and eight suppliers are listed for this compound. Additional details are available on the gabapentin profile page.
Summary for GRALISE
| International Patents: | 54 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 109 |
| Clinical Trials: | 7 |
| Patent Applications: | 4,566 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | GRALISE at DailyMed |
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-(AMINOETHYL)CYCLOHEXANEACETIC 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 |
| AK-35803 |
| AKOS000280865 |
| AM010472 |
| AM20070538 |
| AN-14914 |
| ANW-43124 |
| Apo-Gabapentin |
| Apotex brand of gabapentin |
| Aventis brand of gabapentin |
| BB_SC-1512 |
| BBL010794 |
| 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 |
| D0J0ZS |
| DB00996 |
| DDS-2003 |
| DM-1796 |
| DM-5689 |
| DR000202 |
| DSSTox_CID_74 |
| DSSTox_GSID_20074 |
| DSSTox_RID_75350 |
| DTXSID0020074 |
| EINECS 262-076-3 |
| EN300-52516 |
| EU-0100582 |
| Fanatrex |
| FT-0626586 |
| G-154 |
| G0318 |
| gabamox |
| Gabapen |
| gabapentin |
| Gabapentin (JAN/USAN/INN) |
| gabapentin (Neurontin) |
| Gabapentin [USAN:INN:BAN] |
| Gabapentin [USAN:USP:INN:BAN] |
| Gabapentin GR |
| Gabapentin Hexal |
| 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 Stada |
| Gabapentin-ER |
| Gabapentin-ratiopharm |
| Gabapentin, European Pharmacopoeia (EP) Reference Standard |
| Gabapentin, pharmaceutical secondary standard; traceable to USP |
| 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 |
| GABAPETINE |
| Gabarone |
| GBN |
| Go 3450 |
| GOE 2450 |
| GOE 3450 |
| Goe-3450 |
| Gralise (TN) |
| GTPL5483 |
| Hexal brand of gabapentin |
| HMS1570N03 |
| HMS2089J03 |
| HMS2097N03 |
| HMS2236O03 |
| HMS3261F06 |
| HMS3650A20 |
| 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 |
| 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 |
| Novopharm brand of gabapentin |
| NSC-742194 |
| NSC742194 |
| OR207423 |
| Parke Davis brand of gabapentin |
| Pfizer brand of gabapentin |
| Pharmascience brand of gabapentin |
| PMS-Gabapentin |
| Prestwick_151 |
| Prestwick0_000861 |
| Prestwick1_000861 |
| Prestwick2_000861 |
| Prestwick3_000861 |
| ratiopharm brand of gabapentin |
| 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 |
| ST2410212 |
| Stadapharm brand of gabapentin |
| STK598009 |
| Therapentin-90 |
| TL8003814 |
| Tocris-0806 |
| Tox21_110157 |
| Tox21_110157_1 |
| Tox21_500582 |
| TR-020802 |
| TRA0097671 |
| UGJMXCAKCUNAIE-UHFFFAOYSA-N |
| UNII-6CW7F3G59X |
| Vultin |
| Warner-Lambert brand of gabapentin |
| Z1258578343 |
| ZINC4949 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| 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 |
|---|---|---|---|---|---|---|---|
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | GRALISE | gabapentin | TABLET;ORAL | 022544-002 | Jan 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for GRALISE
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 300 mg and 600 mg | ➤ Subscribe | 2011-10-31 |
Non-Orange Book US Patents for GRALISE
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,580,303 | Gastric retained gabapentin dosage form | ➤ Sign Up |
| 8,475,813 | Methods of treatment using a gastric retained gabapentin dosage | ➤ Sign Up |
| 8,231,905 | Gastric retained gabapentin dosage form | ➤ Sign Up |
| 8,333,991 | Gastric retained gabapentin dosage form | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for GRALISE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Portugal | 1294363 | ➤ Sign Up |
| South Korea | 100716756 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 03035177 | ➤ Sign Up |
| Canada | 2412671 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
