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Tobramycin - Generic Drug Details
What are the generic drug sources for tobramycin and what is the scope of patent protection?
Tobramycin
is the generic ingredient in eleven branded drugs marketed by Novartis, Mylan Speciality Lp, Akorn, Alcon Pharms Ltd, Alembic Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Somerset Theraps Llc, Sandoz Inc, Chiesi Usa Inc, Pulmoflow Inc, Akorn Inc, Amneal Pharms, Dr Reddys Labs Sa, Lupin, Mylan, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, X Gen Pharms, and Xellia Pharms Aps, and is included in fifty-two NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tobramycin has two hundred and seventy-five patent family members in forty-four countries.
There are eighteen drug master file entries for tobramycin. Twenty-eight suppliers are listed for this compound.
Summary for tobramycin
| International Patents: | 275 |
| US Patents: | 14 |
| Tradenames: | 11 |
| Applicants: | 29 |
| NDAs: | 52 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 28 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 103 |
| Patent Applications: | 6,604 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for tobramycin |
| Drug Sales Revenues: | Drug sales revenues for tobramycin |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tobramycin |
| DailyMed Link: | tobramycin at DailyMed |
Recent Clinical Trials for tobramycin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sutphin Drugs | Early Phase 1 |
| University of Dundee | Phase 2 |
| Maisonneuve-Rosemont Hospital | Phase 1 |
Recent Litigation for tobramycin
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Chiesi U.S.A., Inc. v. Teva Pharmaceuticals USA, Inc. | 2017-12-07 |
| Novartis AG v. Lee | 2013-01-14 |
| NOVARTIS AG v. KAPPOS | 2011-05-03 |
Pharmacology for tobramycin
| Drug Class | Aminoglycoside Antibacterial |
Medical Subject Heading (MeSH) Categories for tobramycin
Synonyms for tobramycin
| (1S,2S,3R,4S,6R)-4,6-diamino-3-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyloxy)-2-hydroxycyclohexyl 3-amino-3-deoxy-alpha-D-glucopyranoside |
| (1S,2S,3R,4S,6R)-4,6-diamino-3-[(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl)oxy]-2-hydroxycyclohexyl 3-amino-3-deoxy-alpha-D-glucopyranoside |
| (2S,3R,4S,5S,6R)-4-amino-2-(((1S,2S,3R,4S,6R)-4,6-diamino-3-(((2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-6-(hydroxymethyl)tetrahyd |
| (2S,3R,4S,5S,6R)-4-amino-2-(((1S,2S,3R,4S,6R)-4,6-diamino-3-(((2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,5-diol |
| (2S,3R,4S,5S,6R)-4-amino-2-((1S,2S,3R,4S,6R)-4,6-diamino-3-((2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxytetrahydro-2H-pyran-2-yloxy)-2-hydroxycyclohexyloxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,5-diol |
| (2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxy-tetrahydropyran-2-yl]oxy-2-hydroxy-cyclohexoxy]-6-(hydroxymethyl)tetrahydropyran-3,5-diol |
| (2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol |
| (2S,3R,4S,5S,6R)-4-amino-2-{[(1S,2S,3R,4S,6R)-4,6-diamino-3-{[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy}-2-hydroxycyclohexyl]oxy}-6-(hydroxymethyl)oxane-3,5-diol |
| 1-Epitobramycin |
| 11098-01-4 |
| 11111-45-8 |
| 3'-Deoxykanamycin B |
| 32986-56-4 |
| 34337-51-4 |
| 37321-13-4 |
| 4-(2,6-Diamino-2,3,6-trideoxy-alpha-D-glycopyranosyl)-6-(3-amino-3-deoxy-alpha-D-glycopyranosyl)-2-deoxystreptamine |
| 4-AMINO-2-[4,6-DIAMINO-3-(3-AMINO-6-AMINOMETHYL-5-HYDROXY-TETRAHYDRO-PYRAN-2-YLOXY)-2-HYDROXY-CYCLOHEXYLOXY]-6-HYDROXYMETHYL-TETRAHYDRO-PYRAN-3,5-DIOL |
| 49842-07-1 (Sulfate) |
| 54330-95-9 |
| 70322-33-7 |
| 986T564 |
| A-8891 |
| AB00052438_13 |
| AB00052438_14 |
| AB00052438-12 |
| AB00513858 |
| AB2000616 |
| AC1L1VI0 |
| AC1Q2AOW |
| AKOS016339662 |
| Aktob |
| AN-9578 |
| AOB5629 |
| API0004434 |
| BDBM50366778 |
| Bethkis |
| Bethkis (TN) |
| BIDD:GT0503 |
| BIT0802 |
| BPBio1_000647 |
| BRD-K05619559-001-12-7 |
| BRN 1357507 |
| Brulamycin |
| BSPBio_000587 |
| BSPBio_002036 |
| C-22669 |
| C00397 |
| C18H37N5O9 |
| CAS-32986-56-4 |
| CC-35084 |
| CCG-39936 |
| CHEBI:28864 |
| CHEMBL1747 |
| CPD000058793 |
| CS-2547 |
| D-Streptamine, O-3-amino-3-deoxy-.alpha.-D-glucopyranosyl-(1->6)-O-[2,6-diamino-2,3,6-trideoxy-.alpha.-D-ribo-hexopyranosyl-(1->4)]-2-deoxy- |
| D-Streptamine, O-3-amino-3-deoxy-.alpha.-D-glucopyranosyl-(1->6)-O-[2,6-diamino-2,3,6-trideoxy-.alpha.-D-ribohexopyranosyl-(1->4)]-2-deoxy- |
| D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1->6)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1->4))-2-deoxy- |
| D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1-4))-2-deoxy- |
| D00063 |
| DB00684 |
| Deoxykanamycin B |
| Distobram |
| DSSTox_CID_3680 |
| DSSTox_GSID_23680 |
| DSSTox_RID_77144 |
| DTXSID8023680 |
| EINECS 251-322-5 |
| Gernebcin |
| Gotabiotic |
| HMS2090B16 |
| HMS2092M17 |
| HMS2096N09 |
| HMS3713N09 |
| HSDB 3259 |
| HY-B0441 |
| J10405 |
| KBio2_001552 |
| KBio2_004120 |
| KBio2_006688 |
| KBio3_001536 |
| KBioGR_001104 |
| KBioSS_001552 |
| Kitabis Pak |
| KS-1405 |
| Lilly 47663 |
| LS-146940 |
| LS-187329 |
| MFCD00077885 |
| MLS000069544 |
| MolPort-003-665-548 |
| NCGC00016814-01 |
| NCGC00178852-01 |
| NCGC00178852-02 |
| Nebcin |
| Nebcin (Sulfate) |
| Nebicin |
| NEBRAMYCIN |
| Nebramycin 6 |
| Nebramycin factir 6 |
| Nebramycin factor 6 |
| Nebramycin VI |
| Nebramycin-Faktor 6 |
| NLVFBUXFDBBNBW-PBSUHMDJSA-N |
| NSC 180514 |
| NSC-757352 |
| NSC757352 |
| O-[3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-->6)]-O-[2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-->4)]-2-deoxy-D-streptamine |
| O-[3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1->6)]-O-[2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1->4)]-2-deoxy-D-streptamine |
| O-3-Amino-3-deoxy-?-D-glucopyranosyl-(1-6)-O-[2,6-diamino-2,3,6-trideoxy-?-D-ribohexopyranosyl-(1-4)]-2-deoxy-D-streptamine |
| O-3-Amino-3-deoxy-a-D-glucopyranosyl-(1-6)-O-[2,6-diamino-2,3,6-trideoxy-a -D-ribo-hexopyranosyl-(1-4)]-2-deoxy-D-streptamine |
| O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribo-hexopyranosyl-(1-6))-2-deoxy-L-streptamine |
| O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-4))-2-deoxy-D-streptamine |
| O-3-Amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-4))-2-deoxy-D-streptamine |
| Obramycin |
| Pharmakon1600-01500579 |
| Prestwick3_000544 |
| Q-201837 |
| ro-2H-pyran-3,5-diol |
| s2514 |
| SAM001246911 |
| SBI-0051915.P003 |
| SC-45657 |
| SCHEMBL2838 |
| SMR000058793 |
| SPBio_000295 |
| Spectrum_001072 |
| SPECTRUM1500579 |
| Spectrum2_000078 |
| Spectrum3_000588 |
| Spectrum4_000752 |
| Spectrum5_001038 |
| SPRC-AB01 |
| SR-01000721898 |
| SR-01000721898-2 |
| SR-05000001726 |
| SR-05000001726-1 |
| SR-05000001726-2 |
| Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-trideoxy-alpha-D-ribohexopyranosyl-(1-6))-2-deoxy-, D- |
| Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-4)-O-(2,6-diamino-2,3,6-tyrideoxy-alpha-D-ribohexopyranosyl-(1-6))-2-deoxy-, D- |
| Sybryx |
| Tenebrimycin |
| Tenemycin |
| TOA-(1-6)2TB-(4-1)TOC |
| TOA-(1-6)TOB-(4-1)TOC |
| Tobacin |
| Tobi |
| Tobi (TN) |
| Tobi Podhaler |
| Tobracin |
| Tobracin (TN) |
| Tobradex |
| Tobradistin |
| Tobralex |
| Tobramaxin |
| Tobramicin |
| Tobramicina |
| Tobramicina [INN-Spanish] |
| Tobramitsetin |
| Tobramycetin |
| Tobramycin (JP17/USP) |
| Tobramycin [2M+H] |
| Tobramycin [USAN:BAN:INN:JAN] |
| Tobramycin [USAN:USP:INN:BAN:JAN] |
| Tobramycin Base |
| Tobramycin for Inhalation |
| tobramycin solution for inhalation |
| TOBRAMYCIN SULFATE |
| Tobramycin, 97% |
| Tobramycin, Antibiotic for Culture Media Use Only |
| Tobramycin,(S) |
| Tobramycine |
| Tobramycine [INN-French] |
| Tobramycinum |
| Tobramycinum [INN-Latin] |
| Tobrased |
| Tobrasone |
| Tobrex |
| Tobrex (TN) |
| torbamycin |
| Tox21_110626 |
| TOY |
| UNII-NQJ13I4Z9U component NLVFBUXFDBBNBW-PBSUHMDJSA-N |
| UNII-VZ8RRZ51VK |
| VZ8RRZ51VK |
| ZINC8214692 |
| ZX-AFC000193 |
Paragraph IV (Patent) Challenges for TOBRAMYCIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BETHKIS | SOLUTION;INHALATION | tobramycin | 201820 | 2017-08-31 |
| TOBI | SOLUTION;INHALATION | tobramycin | 050753 | 2009-06-29 |
US Patents and Regulatory Information for tobramycin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Fresenius Kabi Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 065122-002 | Nov 29, 2002 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Hospira | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063161-001 | May 29, 1991 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Fresenius Kabi Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 050789-001 | Jul 13, 2004 | AP | 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 |
Expired US Patents for tobramycin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | Start Trial | Start Trial |
| Mylan Speciality Lp | TOBI | tobramycin | SOLUTION;INHALATION | 050753-001 | Dec 22, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tobramycin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1280520 | Start Trial |
| Japan | 4943838 | Start Trial |
| Japan | 2001517691 | Start Trial |
| Japan | 2011116788 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tobramycin
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1280520 | 300722 | Netherlands | Start Trial | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 |
| 1273292 | C01273292/01 | Switzerland | Start Trial | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009 |
| 1280520 | 92678 | Luxembourg | Start Trial | PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725 |
| 1280520 | CA 2015 00017 | Denmark | Start Trial | PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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ISSN: 2162-2639
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Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.