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Gabapentin - Generic Drug Details
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What are the generic sources for gabapentin and what is the scope of gabapentin patent protection?
Gabapentin
is the generic ingredient in four branded drugs marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Epic Pharma Llc, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro Pharm, Teva Pharms, Watson Labs, Pfizer Pharms, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Taro, Tris Pharma Inc, Parke Davis, Alkem Labs Ltd, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Assertio, and Arbor Pharms Llc, and is included in fifty-three NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are twenty-eight drug master file entries for gabapentin. One hundred and eleven suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for gabapentin
| US Patents: | 14 |
| Tradenames: | 4 |
| Applicants: | 39 |
| NDAs: | 53 |
| Drug Master File Entries: | 28 |
| Suppliers / Packagers: | 111 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 330 |
| Patent Applications: | 6,656 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for gabapentin |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for gabapentin |
| DailyMed Link: | gabapentin at DailyMed |
Pharmacology for gabapentin
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Synonyms for gabapentin
| (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 (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 |
| 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 gabapentin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ivax Sub Teva Pharms | GABAPENTIN | gabapentin | TABLET;ORAL | 076017-003 | Apr 28, 2004 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Amneal Pharms | GABAPENTIN | gabapentin | SOLUTION;ORAL | 202024-001 | Mar 23, 2012 | AA | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | BX | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Hikma Pharms | GABAPENTIN | gabapentin | TABLET;ORAL | 078782-001 | Jul 21, 2011 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Acella Pharms Llc | GABAPENTIN | gabapentin | SOLUTION;ORAL | 076403-001 | May 1, 2012 | AA | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for gabapentin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-003 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-001 | Oct 9, 1998 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-001 | Oct 9, 1998 | ➤ Sign Up | ➤ Sign Up |
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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International Patents for gabapentin
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Israel | 158359 | ➤ Sign Up |
| Tunisia | SN03125 | ➤ Sign Up |
| Hungary | 0401366 | ➤ Sign Up |
| Japan | 2013224324 | ➤ Sign Up |
| Georgia, Republic of | P20053620 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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