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Primidone - Generic Drug Details
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What are the generic drug sources for primidone and what is the scope of patent protection?
Primidone
is the generic ingredient in two branded drugs marketed by Nuro Pharma, Valeant, Amneal Pharm, Anda Repository, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, and Watson Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for primidone. Sixteen suppliers are listed for this compound.
Summary for primidone
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 10 |
| NDAs: | 11 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 16 |
| Bulk Api Vendors: | 84 |
| Clinical Trials: | 24 |
| Patent Applications: | 5,295 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for primidone |
| Drug Sales Revenues: | Drug sales revenues for primidone |
| DailyMed Link: | primidone at DailyMed |
Recent Clinical Trials for primidone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Diego | Phase 1/Phase 2 |
| international essential tremor foundation | Phase 1/Phase 2 |
| Tilray | Phase 1/Phase 2 |
Pharmacology for primidone
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for primidone
Synonyms for primidone
| 125-33-7 |
| 125P337 |
| 13AFD7670Q |
| 2-Deoxyphenobarbital |
| 2-Desoxyphenobarbital |
| 4,5H)-Pyrimidinedione, 5-ethyldihydro-5-phenyl- |
| 4,6(1H,5H)-Pyrimidinedione, 5-ethyldihydro-5-phenyl- |
| 5-24-08-00102 (Beilstein Handbook Reference) |
| 5-Aethyl-5-phenyl-hexahydropyrimidin-4,6-dion |
| 5-Aethyl-5-phenyl-hexahydropyrimidin-4,6-dion [German] |
| 5-ethyl-5-phenyl-1,2,3,5-tetrahydropyrimidine-4,6-dione |
| 5-ethyl-5-phenyl-1,3-diazinane-4,6-dione |
| 5-ethyl-5-phenyl-hexahydropyrimidine-4,6-dione |
| 5-Ethyl-5-phenyldihydro-4,6(1H,5H)-pyrimidinedione |
| 5-Ethyl-5-phenyldihydro-4,6(1H,5H)-pyrimidinedione # |
| 5-ethyl-5-phenyldihydropyrimidine-4,6(1H,5H)-dione |
| 5-Ethyl-5-phenylhexahydropyrimidine-4,6-dione |
| 5-Ethyldihydro-5-phenyl-4,5H)-pyrimidinedione |
| 5-Ethyldihydro-5-phenyl-4,6(1H,5H)-pyrimidinedione |
| 5-ethyldihydro-5-phenyl-4,6[1H,5H]-pyrimidinedione |
| 5-ethylhe xahydro-4,6-dioxo-5-phenylpyrimidine |
| 5-Ethylhexahydro-4,6-dioxo-5-phenylpyrimidine |
| 5-Ethylhexahydro-5-phenylpyrimidine-4,6-dione |
| 5-Phenyl-5-aethylhexahydropyrimidindion-(4,6) |
| 5-Phenyl-5-aethylhexahydropyrimidindion-(4,6) [German] |
| 5-Phenyl-5-ethyl-hexahydropyrimidine-4,6-dione |
| A805374 |
| AB00052079 |
| AB00052079_15 |
| AB00052079_16 |
| AB00052079-14 |
| AB0013274 |
| AB2000396 |
| AC1L1J82 |
| AKOS003368409 |
| AN-22963 |
| ANW-42020 |
| API0003929 |
| Apo-Primidone |
| BC682375 |
| BG0404 |
| BIDD:GT0319 |
| Biomol-NT_000261 |
| BPBio1_000859 |
| BPBio1_000954 |
| BRD-K32247306-001-05-4 |
| BRD-K32247306-001-17-9 |
| BRN 0218034 |
| BSPBio_000866 |
| BSPBio_002225 |
| C07371 |
| CAS-125-33-7 |
| CC-33920 |
| CCG-39231 |
| CCRIS 54 |
| CHEBI:8412 |
| CHEMBL856 |
| CPD000058501 |
| CS-2381 |
| CTK8B3224 |
| Cyral |
| D00474 |
| DB00794 |
| Desoxyphenobarbital |
| Desoxyphenobarbitone |
| DivK1c_000324 |
| DQMZLTXERSFNPB-UHFFFAOYSA-N |
| DSSTox_CID_3510 |
| DSSTox_GSID_23510 |
| DSSTox_RID_77058 |
| DTXSID7023510 |
| EINECS 204-737-0 |
| EU-0101021 |
| FT-0603328 |
| GTPL5338 |
| H808 |
| Hexadiona |
| hexamidine (the antispasmodic) |
| Hexamidine (the antispasmodic) |
| Hexamidine(the antispasmodic) |
| HMS1570L08 |
| HMS1920J20 |
| HMS2092A21 |
| HMS2097L08 |
| HMS2236G03 |
| HMS3259K04 |
| HMS3263M03 |
| HMS3266H18 |
| HMS3369J12 |
| HMS3655L05 |
| HMS3714L08 |
| HMS501A06 |
| HSDB 3169 |
| HY-B0339 |
| I06-0632 |
| IDI1_000324 |
| J-005215 |
| K-1838 |
| KBio1_000324 |
| KBio2_001312 |
| KBio2_003880 |
| KBio2_006448 |
| KBio3_001725 |
| KBioGR_000969 |
| KBioSS_001312 |
| KS-00000XM8 |
| KS-5217 |
| Lepimidin |
| Lepsiral |
| Liskantin |
| Lopac-P-7295 |
| Lopac0_001021 |
| LP01021 |
| LS-48 |
| Majsolin |
| MCULE-2519004832 |
| Medi-Pets |
| Midone |
| Milepsin |
| Misodine |
| Misolyne |
| Mizodin |
| Mizolin |
| MLS000028593 |
| MLS001055411 |
| MLS001074125 |
| MolPort-001-783-659 |
| Myidone |
| Mylepsin |
| Mylepsinum |
| Mysedon |
| Mysoline |
| Mysoline (TN) |
| Mysoline;Neurosyn;Mylepsin |
| NC00532 |
| NCGC00015834-01 |
| NCGC00015834-02 |
| NCGC00015834-03 |
| NCGC00015834-04 |
| NCGC00015834-05 |
| NCGC00015834-06 |
| NCGC00015834-07 |
| NCGC00015834-08 |
| NCGC00015834-09 |
| NCGC00015834-10 |
| NCGC00015834-11 |
| NCGC00015834-12 |
| NCGC00015834-13 |
| NCGC00015834-14 |
| NCGC00015834-15 |
| NCGC00015834-16 |
| NCGC00015834-17 |
| NCGC00015834-19 |
| NCGC00016377-01 |
| NCGC00023254-02 |
| NCGC00023254-04 |
| NCGC00023254-05 |
| NCGC00023254-06 |
| NCGC00023254-07 |
| NCGC00023254-08 |
| NCGC00023254-09 |
| NCGC00023254-10 |
| NCGC00257146-01 |
| NCGC00259497-01 |
| NCGC00261706-01 |
| NCI-C56360 |
| Neurosyn |
| NINDS_000324 |
| NSC 41701 |
| NSC-41701 |
| NSC-757291 |
| NSC41701 |
| NSC757291 |
| Opera_ID_1083 |
| P 7295 |
| P1906 |
| Pharmakon1600-01500501 |
| Pms Primidone |
| Prestwick0_000933 |
| Prestwick1_000933 |
| Prestwick2_000933 |
| Prestwick3_000933 |
| Prilepsin |
| Primacione |
| Primaclone |
| Primacone |
| Primakton |
| Primidon |
| Primidona |
| Primidona [INN-Spanish] |
| Primidone (JP17/USP/INN) |
| Primidone (Mysoline) |
| Primidone (primaclone) |
| Primidone [USAN:INN:BAN:JAN] |
| Primidone [USP:INN:BAN:JAN] |
| Primidone for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Primidone Methanol Solution |
| Primidone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Primidone, analytical standard |
| Primidone, European Pharmacopoeia (EP) Reference Standard |
| Primidone, United States Pharmacopeia (USP) Reference Standard |
| Primidone(Mysoline) |
| Primidonum |
| Primidonum [INN-Latin] |
| Primoline |
| Prysoline |
| Pyrimidone ''Medi-pets'' |
| Pyrimidone 'Medi-pets' |
| Pyrimidone "Medi-pets" |
| Pyrimidone Medi-pets |
| Resimatil |
| Roe 101 |
| s1965 |
| SAM002554925 |
| SBB017254 |
| SBI-0050994.P004 |
| SC-18998 |
| SCHEMBL34221 |
| Sertan |
| SMP1_000135 |
| SMR000058501 |
| SPBio_001325 |
| SPBio_003035 |
| Spectrum_000832 |
| SPECTRUM1500501 |
| Spectrum2_001293 |
| Spectrum3_000553 |
| Spectrum4_000485 |
| Spectrum5_001144 |
| SR-01000003162 |
| SR-01000003162-2 |
| SR-01000003162-4 |
| SR-01000003162-5 |
| SR-01000003162-8 |
| ST076725 |
| SW196576-3 |
| Tocris-0830 |
| Tox21_110238 |
| Tox21_110238_1 |
| Tox21_201948 |
| Tox21_303194 |
| Tox21_501021 |
| TR-003816 |
| UNII-13AFD7670Q |
| WLN: T6MV DVMTJ C2 CR |
| ZB000454 |
| ZINC1979 |
US Patents and Regulatory Information for primidone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | PRIMIDONE | primidone | TABLET;ORAL | 085052-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Anda Repository | PRIMIDONE | primidone | TABLET;ORAL | 040626-002 | Sep 29, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal Pharm | PRIMIDONE | primidone | TABLET;ORAL | 040866-002 | Apr 23, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Impax Labs | PRIMIDONE | primidone | TABLET;ORAL | 040717-001 | Feb 12, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Impax Labs | PRIMIDONE | primidone | TABLET;ORAL | 040717-002 | Feb 12, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Lannett | PRIMIDONE | primidone | TABLET;ORAL | 084903-001 | Approved Prior to Jan 1, 1982 | AB | RX | 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 |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.