DrugPatentWatch Database Preview
Gabapentin - Generic Drug Details
What are the generic drug sources for gabapentin and what is the scope of patent protection?
Gabapentin
is the generic ingredient in four branded drugs marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cspc Ouyi, Epic Pharma Llc, Granules India Ltd, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Pfizer Pharms, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Tris Pharma Inc, Parke Davis, Alkem Labs Ltd, Apotex Inc, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Assertio, and Arbor Pharms Llc, and is included in fifty-four NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Gabapentin has one hundred and six patent family members in forty-seven countries.
There are twenty-nine drug master file entries for gabapentin. Eighty-two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for gabapentin
| International Patents: | 106 |
| US Patents: | 14 |
| Tradenames: | 4 |
| Applicants: | 41 |
| NDAs: | 54 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 82 |
| Bulk Api Vendors: | 123 |
| Clinical Trials: | 390 |
| Patent Applications: | 6,399 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for gabapentin |
| Drug Sales Revenues: | Drug sales revenues for gabapentin |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for gabapentin |
| DailyMed Link: | gabapentin at DailyMed |
Recent Clinical Trials for gabapentin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Boston Medical Center | Phase 2 |
| Yale University | N/A |
| Dow University of Health Sciences | Phase 4 |
Recent Litigation for gabapentin
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| In re: Depomed, Inc. | 2015-12-30 |
| Purdue Pharma L.P. v. Depomed, Inc. | 2015-09-15 |
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Endo Pharmaceutical Inc. | 2014-04-17 |
| Purdue Pharma L.P. | 2014-01-24 |
Generic filers with tentative approvals for GABAPENTIN
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 300MG | TABLET; ORAL |
| Start Trial | Start Trial | 600MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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-(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 (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 |
| 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 GABAPENTIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GRALISE | TABLET;ORAL | gabapentin | 022544 | 2011-10-31 |
| NEURONTIN | CAPSULE;ORAL | gabapentin | 020235 | |
| NEURONTIN | TABLET;ORAL | gabapentin | 020882 | |
| NEURONTIN | SOLUTION;ORAL | gabapentin | 021129 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aci Healthcare Ltd | GABAPENTIN | gabapentin | TABLET;ORAL | 203244-001 | Jul 12, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Jiangsu Hengrui Med | GABAPENTIN | gabapentin | CAPSULE;ORAL | 091008-002 | Oct 26, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sandoz | GABAPENTIN | gabapentin | TABLET;ORAL | 076120-001 | Jan 27, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Arbor Pharms Llc | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | 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 gabapentin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-002 | Dec 30, 1993 | Start Trial | Start Trial |
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | Start Trial | Start Trial |
| Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | Start Trial | Start Trial |
| Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-001 | Oct 9, 1998 | Start Trial | Start Trial |
| Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-001 | Oct 9, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for gabapentin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20035200 | Start Trial |
| Israel | 158359 | Start Trial |
| European Patent Office | 1773311 | Start Trial |
| Eurasian Patent Organization | 008087 | Start Trial |
| Eurasian Patent Organization | 200301152 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.