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Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020263

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NDA 020263 describes LUPRON DEPOT-PED, which is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the LUPRON DEPOT-PED profile page.

The generic ingredient in LUPRON DEPOT-PED is leuprolide acetate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for NDA: 020263

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020263

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION 020263 NDA AbbVie Inc. 0074-2108 0074-2108-03 1 KIT in 1 CARTON (0074-2108-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION 020263 NDA AbbVie Inc. 0074-2282 0074-2282-03 1 KIT in 1 CARTON (0074-2282-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength7.5MG/VIAL
Approval Date:Apr 16, 1993TE:RLD:Yes
Patent:6,036,976Patent Expiration:Dec 13, 2016Product Flag?Substance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength3.75MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 16, 1993TE:RLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength7.5MG/VIAL,7.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 16, 1993TE:RLD:Yes

Expired Orange Book Patents for NDA: 020263

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-003Apr 16, 19935,643,607► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-008Aug 15, 20115,716,640► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-005Jan 21, 19945,631,021► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-003Apr 16, 19935,716,640► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-005Jan 21, 19945,480,656► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Accenture
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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.

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