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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 primidone freedom to operate?
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: | 72 |
| Clinical Trials: | 21 |
| Patent Applications: | 5,205 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for primidone |
| DailyMed Link: | primidone at DailyMed |
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 |
| 4,4'-(Hexamethylenedioxy)dibenzamidine |
| 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 |
| Apo-Primidone (TN) |
| Apotex Brand of Primidone |
| Astra Brand of Primidone |
| AstraZeneca Brand of Primidone |
| BC682375 |
| BG0404 |
| BIDD:GT0319 |
| Biomol-NT_000261 |
| BPBio1_000859 |
| BPBio1_000954 |
| BRD-K32247306-001-05-4 |
| 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 |
| D0U5RT |
| DB00794 |
| Desitin Brand of Primidone |
| Desoxyphenobarbital |
| Desoxyphenobarbitone |
| DivK1c_000324 |
| DQMZLTXERSFNPB-UHFFFAOYSA-N |
| DR000411 |
| Draxis Brand of Primidone |
| DSSTox_CID_3510 |
| DSSTox_GSID_23510 |
| DSSTox_RID_77058 |
| DTXSID7023510 |
| EINECS 204-737-0 |
| EU-0101021 |
| FT-0603328 |
| GTPL5338 |
| H808 |
| HE288366 |
| HE303716 |
| Hexadiona |
| hexamidine (the antispasmodic) |
| Hexamidine (the antispasmodic) |
| Hexamidine(the antispasmodic) |
| HMS1570L08 |
| HMS1920J20 |
| HMS2092A21 |
| HMS2097L08 |
| HMS2236G03 |
| HMS3259K04 |
| HMS3263M03 |
| HMS3266H18 |
| HMS3369J12 |
| HMS3655L05 |
| HMS501A06 |
| Holsten Brand of Primidone |
| 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 |
| Liskantin (TN) |
| 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 |
| Mylepsinum (TN) |
| 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 |
| Primidon Holsten |
| Primidona |
| Primidona [INN-Spanish] |
| Primidone (JP15/USP/INN) |
| 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, analytical standard |
| Primidone, European Pharmacopoeia (EP) Reference Standard |
| Primidone, United States Pharmacopeia (USP) Reference Standard |
| Primidone(Mysoline) |
| Primidonum |
| Primidonum [INN-Latin] |
| Primoline |
| Prysoline |
| Prysoline (TN) |
| Pyrimidone ''Medi-pets'' |
| Pyrimidone 'Medi-pets' |
| Pyrimidone "Medi-pets" |
| Pyrimidone (Medi-pets) |
| Pyrimidone Medi-pets |
| Resimatil |
| Resimatil (TN) |
| Roe 101 |
| s1965 |
| SAM002554925 |
| Sanofi-Synthelabo Brand of Primidone |
| SBB017254 |
| SBI-0050994.P004 |
| SC-18998 |
| SCHEMBL34221 |
| Sertan |
| Sertan (TN) |
| SMP1_000135 |
| SMR000058501 |
| SPBio_001325 |
| SPBio_003035 |
| Spectrum_000832 |
| SPECTRUM1500501 |
| Spectrum2_001293 |
| Spectrum3_000553 |
| Spectrum4_000485 |
| Spectrum5_001144 |
| SR-01000003162 |
| SR-01000003162-2 |
| ST076725 |
| Tocris-0830 |
| Tox21_110238 |
| Tox21_110238_1 |
| Tox21_201948 |
| Tox21_303194 |
| Tox21_501021 |
| TR-003816 |
| UNII-13AFD7670Q |
| WLN: T6MV DVMTJ C2 CR |
| Xcel Brand of Primidone |
| ZB000454 |
| Zeneca Brand of Primidone |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma Intl Pharms | PRIMIDONE | primidone | TABLET;ORAL | 040667-002 | Jul 27, 2006 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Watson Labs | PRIMIDONE | primidone | TABLET;ORAL | 083551-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Valeant | MYSOLINE | primidone | TABLET;ORAL | 009170-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Oxford Pharms | PRIMIDONE | primidone | TABLET;ORAL | 040586-001 | Feb 24, 2005 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Lannett | PRIMIDONE | primidone | TABLET;ORAL | 084903-002 | May 24, 2001 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Impax Labs | PRIMIDONE | primidone | TABLET;ORAL | 040717-001 | Feb 12, 2008 | DISCN | 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 |
see a sample report or, see our see our flat-rate plans
see a sample report or, see our see our flat-rate plans
For more information try a trial or see the plans and pricing
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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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