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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKinsey
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Deloitte
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Harvard Business School
Dow
US Department of Justice

Generated: July 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021529

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NDA 021529 describes NEXPLANON, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the NEXPLANON profile page.

The generic ingredient in NEXPLANON is etonogestrel. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the etonogestrel profile page.
Summary for 021529
Tradename:NEXPLANON
Applicant:Organon Usa Inc
Ingredient:etonogestrel
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021529
Generic Entry Date for 021529*:
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: 021529
Ingredient-typeProgesterone Congeners
Suppliers and Packaging for NDA: 021529
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529 NDA Organon USA Inc. 0052-0272 N 0052-0272-01
IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529 NDA Organon USA Inc. 0052-0274 N 0052-0274-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:IMPLANT;IMPLANTATIONStrength68MG/IMPLANT
Approval Date:Jul 17, 2006TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Jul 28, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrength68MG/IMPLANT
Approval Date:May 31, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 28, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Aug 28, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021529

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 ➤ Sign Up ➤ Sign Up
Organon Usa Inc IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 ➤ 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:

Julphar
Queensland Health
McKinsey
Chubb
Cipla
Express Scripts
Baxter
Farmers Insurance
Dow

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