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Last Updated: May 19, 2022

Details for New Drug Application (NDA): 021529


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NDA 021529 describes NEXPLANON, which is a drug marketed by Organon and is included in one NDA. There are four 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. Additional details are available on the etonogestrel profile page.
Summary for 021529
Tradename:NEXPLANON
Applicant:Organon
Ingredient:etonogestrel
Patents:4
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:IMPLANT;IMPLANTATIONStrength68MG/IMPLANT
Approval Date:Jul 17, 2006TE:RLD:No
Patent:See Plans and PricingPatent 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:See Plans and PricingPatent Expiration:May 31, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Sep 28, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021529

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 See Plans and Pricing See Plans and Pricing
Organon IMPLANON etonogestrel IMPLANT;IMPLANTATION 021529-001 Jul 17, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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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 verification 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.