Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
Merck
Farmers Insurance
Federal Trade Commission
AstraZeneca

Generated: March 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021463

« Back to Dashboard

NDA 021463 describes FORTESTA, which is a drug marketed by Endo Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FORTESTA profile page.

The generic ingredient in FORTESTA is testosterone. There are sixty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 021463
Tradename:FORTESTA
Applicant:Endo Pharms
Ingredient:testosterone
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021463
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 021463
Suppliers and Packaging for NDA: 021463
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463 NDA AUTHORIZED GENERIC Par Pharmaceutical 0603-7831 0603-7831-88 1 CANISTER in 1 CARTON (0603-7831-88) > 60 g in 1 CANISTER
FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463 NDA Endo Pharmaceuticals, Inc. 63481-183 63481-183-16 1 CANISTER in 1 CARTON (63481-183-16) > 60 g in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength10MG/0.5GM ACTUATION
Approval Date:Dec 29, 2010TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 9, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Patent:➤ Sign UpPatent Expiration:Nov 9, 2018Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021463

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463-001 Dec 29, 2010 ➤ Sign Up ➤ Sign Up
Endo Pharms FORTESTA testosterone GEL, METERED;TRANSDERMAL 021463-001 Dec 29, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

UBS
Express Scripts
Federal Trade Commission
Baxter
Argus Health
Johnson and Johnson

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.