.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050810

« Back to Dashboard
NDA 050810 describes AZASITE, which is a drug marketed by Oak Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AZASITE profile page.

The generic ingredient in AZASITE is azithromycin. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the azithromycin profile page.

Summary for NDA: 050810

Tradename:
AZASITE
Applicant:
Oak Pharms Inc
Ingredient:
azithromycin
Patents:5
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050810

Ingredient-typeMacrolides

Suppliers and Packaging for NDA: 050810

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZASITE
azithromycin
SOLUTION/DROPS;OPHTHALMIC 050810 NDA Akorn, Inc. 17478-307 17478-307-01 1 BOTTLE, DROPPER in 1 CARTON (17478-307-01) > 1 mL in 1 BOTTLE, DROPPER
AZASITE
azithromycin
SOLUTION/DROPS;OPHTHALMIC 050810 NDA Akorn, Inc. 17478-307 17478-307-03 1 BOTTLE, DROPPER in 1 CARTON (17478-307-03) > 2.5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength1%
Approval Date:Apr 27, 2007TE:RLD:Yes
Patent:6,159,458Patent Expiration:Nov 4, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT
Patent:6,239,113Patent Expiration:Mar 31, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT
Patent:6,569,443Patent Expiration:Mar 31, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT

Expired Orange Book Patents for NDA: 050810

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc
AZASITE
azithromycin
SOLUTION/DROPS;OPHTHALMIC050810-001Apr 27, 20075,192,535► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc