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Gabapentin - Generic Drug Details
What are the generic drug 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, Epic Pharma Llc, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, 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-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. One hundred and nine suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for gabapentin
| International Patents: | 106 |
| US Patents: | 14 |
| Tradenames: | 4 |
| Applicants: | 40 |
| NDAs: | 54 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 109 |
| Bulk Api Vendors: | 118 |
| Clinical Trials: | 379 |
| Patent Applications: | 6,722 |
| 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 |
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Invagen Pharms | GABAPENTIN | gabapentin | CAPSULE;ORAL | 090705-001 | Dec 30, 2009 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Invagen Pharms | GABAPENTIN | gabapentin | CAPSULE;ORAL | 090705-003 | Dec 30, 2009 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Glenmark Pharms Ltd | GABAPENTIN | gabapentin | TABLET;ORAL | 077662-001 | Aug 18, 2006 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Actavis Elizabeth | GABAPENTIN | gabapentin | CAPSULE;ORAL | 075350-001 | Sep 12, 2003 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Aurobindo Pharma Ltd | GABAPENTIN | gabapentin | TABLET;ORAL | 200651-002 | Oct 6, 2011 | AB | 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 |
Expired US Patents for gabapentin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Pharms | NEURONTIN | gabapentin | TABLET;ORAL | 020882-002 | Oct 9, 1998 | ➤ Sign Up | ➤ Sign Up |
| Pfizer Pharms | NEURONTIN | gabapentin | CAPSULE;ORAL | 020235-001 | 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 | CAPSULE;ORAL | 020235-001 | Dec 30, 1993 | ➤ Sign Up | ➤ Sign Up |
| Assertio | GRALISE | gabapentin | TABLET;ORAL | 022544-001 | Jan 28, 2011 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for gabapentin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1446106 | ➤ Sign Up |
| Ukraine | 75138 | ➤ Sign Up |
| Canada | 2412671 | ➤ Sign Up |
| Slovakia | 286227 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007079195 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
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Major Patent Expirations 2019 - 2020
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ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.
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