.

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): 205488

« Back to Dashboard
NDA 205488 describes NATESTO, which is a drug marketed by Aytu Bioscience Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NATESTO profile page.

The generic ingredient in NATESTO is testosterone. There are sixty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the testosterone profile page.

Summary for NDA: 205488

Tradename:
NATESTO
Applicant:
Aytu Bioscience Inc
Ingredient:
testosterone
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 205488

Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists

Suppliers and Packaging for NDA: 205488

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NATESTO
testosterone
GEL, METERED;NASAL 205488 NDA Endo Pharmaceuticals 63481-239 63481-239-01 1 BOTTLE, PUMP in 1 CARTON (63481-239-01) > 60 GEL in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;NASALStrength5.5MG/0.122GM ACTUATION
Approval Date:May 28, 2014TE:RLD:No
Patent:8,574,622Patent Expiration:Feb 4, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,784,869Patent Expiration:Feb 4, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:8,784,882Patent Expiration:Feb 4, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF TESTOSTERONE GEL FORMULATION.


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