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Gemfibrozil - Generic Drug Details
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What are the generic sources for gemfibrozil and what is the scope of freedom to operate?
Gemfibrozil
is the generic ingredient in two branded drugs marketed by Mylan, Purepac Pharm, Pfizer Pharms, Apotex, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Sun Pharm Inds Inc, Teva, Watson Labs, Yaopharma Co Ltd, and Zydus Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for gemfibrozil
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 17 |
| NDAs: | 20 |
| Suppliers / Packagers: | 34 |
| Bulk Api Vendors: | 99 |
| Clinical Trials: | 36 |
| Patent Applications: | 5,974 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for gemfibrozil |
| Drug Sales Revenues: | Drug sales revenues for gemfibrozil |
| DailyMed Link: | gemfibrozil at DailyMed |
Recent Clinical Trials for gemfibrozil
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Seattle Genetics, Inc. | Phase 1 |
| Celgene | Phase 1 |
| Laboratorios Grossman, S.A. | Phase 3 |
Generic filers with tentative approvals for GEMFIBROZIL
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 300MG | CAPSULE;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 gemfibrozil
| Drug Class | Peroxisome Proliferator Receptor alpha Agonist |
| Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Medical Subject Heading (MeSH) Categories for gemfibrozil
Synonyms for gemfibrozil
| 2,2-Dimethyl-5-(2,5-dimethylphenoxy)-pentanoic acid |
| 2,2-Dimethyl-5-(2,5-dimethylphenoxy)pentanoic acid |
| 2,2-Dimethyl-5-(2,5-dimethylphenoxy)valeriansaeure |
| 2,2-Dimethyl-5-(2,5-dimethylphenoxy)valeric Acid |
| 2,2-Dimethyl-5-(2,5-xylyloxy)valeriansaeure |
| 2,2-Dimethyl-5-(2,5-xylyloxy)valeric acid |
| 2,2-Dimethyl-5-(2,5-zlyloxy)valeric acid |
| 25812-30-0 |
| 4TX |
| 5-(2,5-Dimethyl-Phenoxy)-2,2-Dimethyl-Pentanoic Acid |
| 5-(2,5-dimethylphenoxy)-2,2- |
| 5-(2,5-dimethylphenoxy)-2,2-dimethyl-pentanoic acid |
| 5-(2,5-Dimethylphenoxy)-2,2-dimethylpentanoic acid |
| 5-[(2,5-dimethylphenyl)oxy]-2,2-dimethylpentanoic acid |
| A0G461 |
| A818037 |
| AB00052003 |
| AB00052003_17 |
| AB00052003_18 |
| AB00052003-15 |
| AB00052003-16 |
| AB0013344 |
| AB03034 |
| AB2000253 |
| AC-4225 |
| AC1L1FZT |
| AC1Q2JC7 |
| AKOS001606691 |
| AN-12208 |
| API0002816 |
| Apo-Gemfibrozil |
| ARONIS24091 |
| Ausgem |
| AX8032912 |
| BB_SC-04837 |
| BBC/228 |
| BBL010807 |
| BCP08437 |
| BDBM50110590 |
| BG0205 |
| Bolutol |
| BPBio1_000251 |
| BRD-K11129031-001-05-1 |
| BRN 1881200 |
| Brozil |
| BSPBio_000227 |
| BSPBio_002060 |
| C-15436 |
| C07020 |
| CAS-25812-30-0 |
| CC-28946 |
| CCG-40111 |
| CCRIS 318 |
| CG0035 |
| CHEBI:5296 |
| CHEMBL457 |
| Cholespid |
| CI 719 |
| CI-719 |
| Clearol |
| CPD000058393 |
| CS-2244 |
| D00334 |
| DB01241 |
| Decrelip |
| dimethylpentanoic acid |
| DivK1c_000138 |
| DL-414 |
| DSSTox_CID_652 |
| DSSTox_GSID_20652 |
| DSSTox_RID_75712 |
| DTXSID0020652 |
| EINECS 247-280-2 |
| Elmogan |
| Fetinor |
| Fibratol |
| Fibrocit |
| FT-0626641 |
| FT-0700924 |
| G0368 |
| Gem-S |
| Gemcor |
| Gemcor;Jezil;Gen-Fibro;Lopid |
| Gemd |
| Gemfibril |
| Gemfibromax |
| Gemfibrosil |
| Gemfibrozil (JAN/USP/INN) |
| Gemfibrozil (Lopid) |
| GEMFIBROZIL (SEE ALSO PEROXISOME PROJECT (GEMFIBROZIL)) |
| Gemfibrozil [USAN:BAN:INN] |
| Gemfibrozil [USAN:USP:INN:BAN] |
| Gemfibrozil for system suitability, European Pharmacopoeia (EP) Reference Standard |
| Gemfibrozil, 98% |
| Gemfibrozil, analytical standard |
| Gemfibrozil, British Pharmacopoeia (BP) Reference Standard |
| Gemfibrozil, European Pharmacopoeia (EP) Reference Standard |
| Gemfibrozil, Pharmaceutical Secondary Standard; Certified Reference Material |
| Gemfibrozil, United States Pharmacopeia (USP) Reference Standard |
| Gemfibrozil,(S) |
| Gemfibrozilo |
| Gemfibrozilo [INN-Spanish] |
| Gemfibrozilum |
| Gemfibrozilum [INN-Latin] |
| Gemlipid |
| Gemnpid |
| Gen-Fibro |
| Genlip |
| Gevilon Uno |
| Gozid |
| GP1460 |
| GTPL3439 |
| H900 |
| HEMJJKBWTPKOJG-UHFFFAOYSA-N |
| Hidil |
| Hipolixan |
| HMS1568L09 |
| HMS1920B07 |
| HMS2090K14 |
| HMS2091H11 |
| HMS2095L09 |
| HMS2230H24 |
| HMS3259M12 |
| HMS3655C06 |
| HMS3712L09 |
| HMS500G20 |
| HSDB 7735 |
| HY-B0258 |
| I01-1855 |
| IDI1_000138 |
| Innogem |
| Innogen |
| Ipolipid |
| J10068 |
| Jezil |
| KBio1_000138 |
| KBio2_001305 |
| KBio2_003873 |
| KBio2_006441 |
| KBio3_001280 |
| KBioGR_000964 |
| KBioSS_001305 |
| KS-00000VK6 |
| KS-000046JO |
| KS-5192 |
| Lanaterom |
| Lifibron |
| Lipazil |
| Lipigem |
| Lipira |
| Lipizyl |
| Lipozid |
| Lipur |
| Litarek |
| Lopid |
| Lopid (TN) |
| Lopid R |
| Low-Lip |
| LS-1085 |
| MCULE-4563546953 |
| MFCD00079335 |
| Micolip |
| MLS000028421 |
| MLS001055364 |
| MLS006011850 |
| MolPort-001-794-413 |
| NC00565 |
| NCGC00016794-01 |
| NCGC00016794-02 |
| NCGC00016794-03 |
| NCGC00016794-04 |
| NCGC00016794-05 |
| NCGC00016794-06 |
| NCGC00016794-07 |
| NCGC00016794-08 |
| NCGC00016794-09 |
| NCGC00016794-10 |
| NCGC00016794-11 |
| NCGC00016794-13 |
| NCGC00016794-14 |
| NCGC00022722-03 |
| NCGC00022722-04 |
| NCGC00022722-05 |
| NCGC00022722-06 |
| NCGC00022722-07 |
| NCGC00256601-01 |
| NCGC00259546-01 |
| NINDS_000138 |
| Normolip |
| Novo-Gemfibrozil |
| NSC-757024 |
| NSC757024 |
| Nu-Gemfibrozil |
| Opera_ID_1658 |
| Pentanoic acid, 5-(2,5-dimethylphenoxy)-2,2-dimethyl- |
| PEROXISOME PROJECT (GEMFIBROZIL) (SEE ALSO GEMFIBROZIL) |
| Pharmakon1600-10500313 |
| Pilder |
| Polyxit |
| Prestwick_637 |
| Prestwick0_000214 |
| Prestwick1_000214 |
| Prestwick2_000214 |
| Prestwick3_000214 |
| Progemzal |
| Q8X02027X3 |
| Reducel |
| Regulip |
| Renabrazin |
| s1729 |
| SAM002564211 |
| SBB012457 |
| SBI-0051391.P003 |
| SC-17669 |
| SCHEMBL4813 |
| SEL11160931 |
| Sinelip |
| SMR000058393 |
| SPBio_001174 |
| SPBio_002148 |
| Spectrum_000825 |
| SPECTRUM1500313 |
| Spectrum2_001097 |
| Spectrum3_000440 |
| Spectrum4_000562 |
| Spectrum5_000750 |
| Spectrum5_001991 |
| SR-01000000056 |
| SR-01000000056-3 |
| SR-01000000056-4 |
| SR-01000000056-6 |
| SR-01000000056-7 |
| ST072198 |
| STK618740 |
| SW196802-3 |
| Synbrozil |
| Taborcil |
| Tentroc |
| TEVA-A |
| TL8002081 |
| Tox21_110613 |
| Tox21_110613_1 |
| Tox21_201997 |
| Tox21_302784 |
| Trialmin |
| UNII-Q8X02027X3 |
| VA11004 |
| Valeric acid, 2,2-dimethyl-5-(2,5-xylyloxy)- |
| W-107216 |
| WL-Gemfibrozil |
| Z-0832 |
| ZINC1530641 |
| ZX-AS004442 |
US Patents and Regulatory Information for gemfibrozil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yaopharma Co Ltd | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074615-001 | Sep 29, 1995 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Teva | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074256-001 | Oct 31, 1993 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan | GEMFIBROZIL | gemfibrozil | CAPSULE;ORAL | 073466-001 | Jan 25, 1993 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hikma Pharms | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 078599-001 | Aug 16, 2010 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074156-001 | Oct 24, 1994 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074452-001 | Feb 16, 1995 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Purepac Pharm | GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 074360-001 | Aug 31, 1994 | DISCN | No | No | Start Trial | Start Trial | 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 gemfibrozil
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Pharms | LOPID | gemfibrozil | CAPSULE;ORAL | 018422-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| Pfizer Pharms | LOPID | gemfibrozil | CAPSULE;ORAL | 018422-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.