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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050818

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NDA 050818 describes TOBRADEX ST, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the TOBRADEX ST profile page.

The generic ingredient in TOBRADEX ST is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

Summary for NDA: 050818

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 050818

Suppliers and Packaging for NDA: 050818

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRADEX ST
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC 050818 NDA Alcon Laboratories, Inc. 0065-0652 0065-0652-01 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-01) > 1 mL in 1 BOTTLE, DROPPER
TOBRADEX ST
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC 050818 NDA Alcon Laboratories, Inc. 0065-0652 0065-0652-05 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.05%;0.3%
Approval Date:Feb 13, 2009TE:RLD:Yes
Patent:8,450,287Patent Expiration:Dec 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:7,795,316Patent Expiration:Aug 3, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
Patent:8,101,582Patent Expiration:Dec 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS

Expired Orange Book Patents for NDA: 050818

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
TOBRADEX ST
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050818-001Feb 13, 20095,149,694► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Baxter
UBS
Moodys
Fish and Richardson
Colorcon
McKinsey
Johnson and Johnson
Queensland Health
Teva
McKesson

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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