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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020578

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NDA 020578 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 020578
Tradename:ZOLADEX
Applicant:Tersera Theraps Llc
Ingredient:goserelin acetate
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 020578
Generic Entry Date for 020578*:
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: 020578
Medical Subject Heading (MeSH) Categories for 020578
Suppliers and Packaging for NDA: 020578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578 NDA AstraZeneca Pharmaceuticals LP 0310-0951 0310-0951-30 1 POUCH in 1 CARTON (0310-0951-30) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE
ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578 NDA TerSera Therapeutics LLC 70720-951 70720-951-30 1 POUCH in 1 CARTON (70720-951-30) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 10.8MG BASE
Approval Date:Jan 11, 1996TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 13, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 9, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Feb 26, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 020578

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
Merck
Farmers Insurance
Cerilliant
Federal Trade Commission
Chubb
Daiichi Sankyo
Queensland Health

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