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Generated: November 20, 2018

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Details for New Drug Application (NDA): 019726

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NDA 019726 describes ZOLADEX, which is a drug marketed by Tersera Theraps Llc and is included in two NDAs. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ZOLADEX profile page.

The generic ingredient in ZOLADEX is goserelin acetate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the goserelin acetate profile page.
Summary for 019726
Tradename:ZOLADEX
Applicant:Tersera Theraps Llc
Ingredient:goserelin acetate
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 019726
Generic Entry Date for 019726*:
Constraining patent/regulatory exclusivity:
Dosage:
IMPLANT;IMPLANTATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 019726
Medical Subject Heading (MeSH) Categories for 019726
Suppliers and Packaging for NDA: 019726
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726 NDA AstraZeneca Pharmaceuticals LP 0310-0950 0310-0950-36 1 POUCH in 1 CARTON (0310-0950-36) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE
ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726 NDA TerSera Therapeutics LLC 70720-950 70720-950-36 1 POUCH in 1 CARTON (70720-950-36) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 3.6MG BASE
Approval Date:Dec 29, 1989TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 13, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 9, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 26, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 019726

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 ➤ Sign Up ➤ Sign Up
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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US Department of Justice
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Federal Trade Commission

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