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DIABETA Drug Profile
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Which patents cover Diabeta, and what generic alternatives are available?
Diabeta is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in DIABETA is glyburide. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the glyburide profile page.
US ANDA Litigation and Generic Entry Outlook for Diabeta
A generic version of DIABETA was approved as glyburide by TEVA on January 23rd, 2020.
Summary for DIABETA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 3 |
| Patent Applications: | 6,319 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DIABETA at DailyMed |
Recent Clinical Trials for DIABETA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis | Phase 2 |
| Takeda | Phase 4 |
| Takeda | Phase 3 |
Synonyms for DIABETA
| (5-chloro-2-methoxyphenyl)-N-[2-(4-{[(cyclohexylamino)carbonylamino]sulfonyl}p henyl)ethyl]carboxamide |
| 1-((p-(2-(5-Chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexyl urea |
| 1-((p-(2-(5-Chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexylurea |
| 1-(p-(2-(5-Chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexylurea |
| 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea |
| 1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulfonyl}-3-cyclohexylurea;1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulfonyl}-3-cyclohexylurea |
| 10238-21-8 |
| 5-Chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxybenzamide |
| 5-Chloro-N-(2-[4-(([(cyclohexylamino)carbonyl]amino)sulfonyl)phenyl]ethyl)-2-methoxybenzamide # |
| 5-chloro-N-(2-{4-[(cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-2-methoxybenzamide |
| 5-chloro-N-(2-{4-[N-(N-cyclohexylcarbamoyl)sulfamoyl]phenyl}ethyl)-2-methoxybenzamide |
| 5-Chloro-N-(4-(N-(cyclohexylcarbamoyl)sulfamoyl)-phenethyl)-2-methoxybenzamide |
| 5-Chloro-N-(4-(N-(cyclohexylcarbamoyl)sulfamoyl)phenethyl)-2-methoxybenzamide |
| 5-chloro-N-[2-(4-{[(cyclohexylcarbamoyl)amino]sulfonyl}phenyl)ethyl]-2-methoxybenzamide |
| 5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxy-benzamide |
| 5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide |
| 5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide. |
| 5-Chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]-amino]sulfonyl]phenyl]-ethyl]-2-methoxybenzamide |
| 5-Chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide |
| 5-Chloro-N-[2-[4-[[[(Cylcohexylamino)carbonyl]amino]sulphonyl]phenyl]ethyl]-2-methoxybenzamide |
| 5-chloro-N-[4-({[(cyclohexylamino)carbonyl]amino}sulfonyl)phenethyl]-2-methoxybenzamide |
| 5-Chloro-N-[4-(3-cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide |
| 5-Chloro-N-[4-(cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide |
| 78637-EP2270001A1 |
| 78637-EP2270011A1 |
| 78637-EP2272825A2 |
| 78637-EP2272841A1 |
| 78637-EP2275414A1 |
| 78637-EP2287165A2 |
| 78637-EP2287166A2 |
| 78637-EP2292620A2 |
| 78637-EP2298750A1 |
| 78637-EP2298776A1 |
| 78637-EP2298779A1 |
| 78637-EP2301923A1 |
| 78637-EP2301936A1 |
| 78637-EP2305648A1 |
| 78637-EP2308847A1 |
| A19539 |
| AB00051949 |
| AB00051949_18 |
| AB00051949_19 |
| AB00051949-16 |
| AB00051949-17 |
| AB0012611 |
| AB2000243 |
| Abbenclamide |
| AC1L1G1Q |
| AC1Q44V7 |
| ACMC-20a66i |
| Adiab |
| AJ-23371 |
| AKOS001487495 |
| Amglidia |
| AN-20367 |
| ANW-58936 |
| AOB6214 |
| Apo-Glibenclamide |
| Azuglucon |
| Bastiverit |
| BCP05327 |
| BCP9000729 |
| BDBM50012957 |
| Benclamin |
| Benzamide, 5-chloro-N-(2-(4-((((cyclohexylamino)carbonyl)amino)sulfonyl)phenyl)ethyl)-2-methoxy- |
| Benzamide, 5-chloro-N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxy- |
| Betanase |
| Betanese 5 |
| BG0207 |
| BIDD:GT0239 |
| Bio1_000076 |
| Bio1_000565 |
| Bio1_001054 |
| Bio2_000071 |
| Bio2_000551 |
| BPBio1_000344 |
| BRD-K36927236-001-06-0 |
| BRD-K36927236-001-17-7 |
| BRN 2230085 |
| BSPBio_000312 |
| BSPBio_001351 |
| BSPBio_003053 |
| C-22898 |
| C07022 |
| C23H28ClN3O5S |
| Calabren |
| CAS-10238-21-8 |
| CBiol_001790 |
| CCG-39618 |
| CHEBI:5441 |
| CHEMBL472 |
| CPD000058229 |
| CS-1075 |
| CTK8B7917 |
| Cytagon |
| D00336 |
| Daonil |
| DB01016 |
| Debtan |
| Delmide |
| Dia-basan |
| Diabeta (TN) |
| Diabiphage |
| Dibelet |
| DivK1c_000481 |
| DSSTox_CID_17237 |
| DSSTox_GSID_37237 |
| DSSTox_RID_79313 |
| DTXSID0037237 |
| Duraglucon |
| EINECS 233-570-6 |
| EU-0100499 |
| Euclamin |
| Euglucan |
| Euglucon |
| Euglucon 5 |
| Euglucon N |
| Euglykon |
| FT-0601608 |
| G 0639 |
| G-150 |
| G0382 |
| GBM |
| GBN 5 |
| Gen-Glybe |
| Gewaglucon |
| GIBENCLAMIDE |
| Gilemal |
| Glamide |
| Glibadone |
| Gliban |
| Gliben |
| Gliben-Puren N |
| Glibenbeta |
| Glibenclamid AL |
| Glibenclamid Basics |
| Glibenclamid Fabra |
| Glibenclamid Genericon |
| Glibenclamid Heumann |
| Glibenclamid Riker M |
| Glibenclamid Riker M. |
| Glibenclamid-Cophar |
| Glibenclamid-Ratiopharm |
| Glibenclamida |
| Glibenclamida [INN-Spanish] |
| Glibenclamide |
| Glibenclamide (JP17/INN) |
| Glibenclamide [INN] |
| Glibenclamide 1.0 mg/ml in Acetonitrile |
| Glibenclamide B.P. |
| Glibenclamide for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Glibenclamide,(S) |
| Glibenclamidum |
| Glibenclamidum [INN-Latin] |
| Glibenil |
| Glibens |
| Glibesyn |
| Glibet |
| Glibetic |
| Glibil |
| Gliboral |
| Glicem |
| Glidiabet |
| Glimel |
| Glimide |
| Glimidstata |
| Glisulin |
| Glitisol |
| Glubate |
| Gluben |
| Gluco-Tablimen |
| Glucobene |
| Glucohexal |
| Glucolon |
| Glucomid |
| Glucoremed |
| Glucoven |
| Glyben |
| Glybenclamide |
| Glybenclamide, >=99% (HPLC) |
| Glybenclamide, European Pharmacopoeia (EP) Reference Standard |
| Glybenzcyclamide |
| glyburide |
| Glyburide (Diabeta) |
| glyburide (glibenclamide) |
| Glyburide (Glibenclamide), Pharmaceutical Secondary Standard; Certified Reference Material |
| Glyburide (micronized) |
| Glyburide (USP) |
| Glyburide [USAN:USP] |
| Glyburide [USAN] |
| Glyburide, meets USP testing specifications |
| Glyburide, United States Pharmacopeia (USP) Reference Standard |
| Glycolande |
| Glycomin |
| Glycron |
| Glynase |
| Glynase (TN) |
| GP8701 |
| GTPL2414 |
| HB 419 |
| HB-419 |
| HB-420 |
| HD 419 |
| Hemi-Daonil |
| Hexaglucon |
| HMS1361D13 |
| HMS1568P14 |
| HMS1791D13 |
| HMS1922L08 |
| HMS1989D13 |
| HMS2089L06 |
| HMS2093P04 |
| HMS2095P14 |
| HMS3259O12 |
| HMS3261D19 |
| HMS3267A15 |
| HMS3402D13 |
| HMS3428D15 |
| HMS3651E17 |
| HMS3712P14 |
| HMS501I03 |
| Humedia |
| HY-15206 |
| I06-0716 |
| IDI1_000481 |
| IDI1_033821 |
| J10021 |
| KB-73471 |
| KBio1_000481 |
| KBio2_000071 |
| KBio2_000730 |
| KBio2_002639 |
| KBio2_003298 |
| KBio2_005207 |
| KBio2_005866 |
| KBio3_000141 |
| KBio3_000142 |
| KBio3_002273 |
| KBioGR_000071 |
| KBioGR_001897 |
| KBioSS_000071 |
| KBioSS_000730 |
| KS-5326 |
| Lederglib |
| Libanil |
| Lisaglucon |
| Lopac-G-0639 |
| Lopac0_000499 |
| LP00499 |
| LS-159295 |
| Maninil |
| MCULE-2351642942 |
| Med-Glionil |
| Melix |
| MFCD00056625 |
| Micronase |
| Micronase (TN) |
| Micronized glyburide |
| Miglucan |
| MLS000069721 |
| MLS001077262 |
| MolPort-000-784-850 |
| N-(4-(.beta.-(2-Methoxy-5-chlorbenzamido)-aethyl)-benzolsulfonyl)-N'-cyclohexyl-harnstoff |
| N-(4-(2-(5-Chloro-2-methoxybenzamido)ethyl)phenylsulfonyl)-N'-cyclohexylurea |
| N-(4-(beta-(2-Methoxy-5-chlorbenzamido)-aethyl)-benzolsulfonyl)-N'-cyclohexyl-harnstoff |
| N-[(4-{2-[(5-chloro-2-methoxyphenyl)carbonylamino]ethyl}phenyl)sulfonyl](cyclo hexylamino)carboxamide |
| N-p-[2-(5-Chloro-2-methoxybenzamido)-ethyl]benzene-sulfonyl-N -cyclohexylurea |
| N-p-[2-(5-Chloro-2-methoxybenzamido)-ethyl]benzene-sulfonyl-N'-cyclohexylurea |
| N-p-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonyl-N'-cyclohexylurea |
| Nadib |
| NC00566 |
| NCGC00015467-01 |
| NCGC00015467-02 |
| NCGC00015467-03 |
| NCGC00015467-04 |
| NCGC00015467-05 |
| NCGC00015467-06 |
| NCGC00015467-07 |
| NCGC00015467-08 |
| NCGC00015467-09 |
| NCGC00015467-10 |
| NCGC00015467-11 |
| NCGC00015467-12 |
| NCGC00015467-13 |
| NCGC00015467-14 |
| NCGC00015467-15 |
| NCGC00015467-16 |
| NCGC00015467-17 |
| NCGC00015467-18 |
| NCGC00015467-20 |
| NCGC00015467-36 |
| NCGC00016689-01 |
| NCGC00023447-02 |
| NCGC00023447-04 |
| NCGC00023447-05 |
| NCGC00023447-06 |
| NCGC00023447-07 |
| NCGC00023447-08 |
| NCGC00023447-09 |
| NCGC00023447-10 |
| NCGC00023447-11 |
| NCGC00023447-12 |
| NCGC00254662-01 |
| NCGC00261184-01 |
| Neogluconin |
| NINDS_000481 |
| Norglicem 5 |
| Normoglucon |
| Novo-Glyburide |
| NSC-759618 |
| NSC759618 |
| Opera_ID_801 |
| Oprea1_764617 |
| Orabetic |
| Pharmakon1600-02300229 |
| Pira |
| Praeciglucon |
| PresTab |
| Prestwick_569 |
| Prestwick0_000316 |
| Prestwick1_000316 |
| Prestwick2_000316 |
| Prestwick3_000316 |
| Probes1_000431 |
| Probes2_000378 |
| Prodiabet |
| Renabetic |
| RP-1127 |
| RT-000122 |
| S1716 |
| SAM002564212 |
| SB17414 |
| SBB057426 |
| SBI-0050483.P003 |
| SC-17437 |
| SCHEMBL22009 |
| Semi-daonil |
| Semi-Euglucon |
| Semi-Gliben-Puren N |
| SMR000058229 |
| SPBio_001831 |
| SPBio_002531 |
| Spectrum_000250 |
| Spectrum2_001816 |
| SPECTRUM2300229 |
| Spectrum3_001327 |
| Spectrum4_001199 |
| Spectrum5_001631 |
| SR-01000000196 |
| SR-01000000196-2 |
| SR-01000000196-4 |
| SR-01000000196-5 |
| SR-01000000196-6 |
| SR-01000000196-8 |
| ST024780 |
| STK362992 |
| Sugril |
| Suraben |
| SW195828-5 |
| SX6K58TVWC |
| SYN3026 |
| Tiabet |
| Tocris-0911 |
| Tox21_110158 |
| Tox21_110158_1 |
| Tox21_300758 |
| Tox21_500499 |
| U 26452 |
| U-26,452 |
| U-26452 |
| UNII-SX6K58TVWC |
| UPCMLD-DP006 |
| UPCMLD-DP006:001 |
| UR 606 |
| Urea, 1-((p-(2-(chloro-o-anisamido)ethyl)phenyl)sulfonyl)-3-cyclohexyl- |
| Urea, 1-(p-(2-(5-chloro-2-methoxybenzamido)ethyl)benzenesulfonyl)-3-cyclohexyl- |
| W-108874 |
| W-5054 |
| Yuglucon |
| Z277540138 |
| ZINC537805 |
| ZNNLBTZKUZBEKO-UHFFFAOYSA-N |
US Patents and Regulatory Information for DIABETA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-001 | May 1, 1984 | AB2 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-002 | May 1, 1984 | AB2 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-003 | May 1, 1984 | AB2 | RX | Yes | Yes | 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 DIABETA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-003 | May 1, 1984 | Start Trial | Start Trial |
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-002 | May 1, 1984 | Start Trial | Start Trial |
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-001 | May 1, 1984 | Start Trial | Start Trial |
| Sanofi Aventis Us | DIABETA | glyburide | TABLET;ORAL | 017532-003 | May 1, 1984 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
