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Last Updated: May 30, 2023

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. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the etonogestrel profile page.
Summary for 021529
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021529
Generic Entry Date for 021529*:
Constraining patent/regulatory exclusivity:

*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
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 LLC 78206-145 78206-145-01 1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK
NEXPLANON etonogestrel IMPLANT;IMPLANTATION 021529 NDA Organon LLC 78206-145 78206-145-01 1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK

Profile for product number 001

Approval Date:Jul 17, 2006TE:RLD:No
Patent:⤷  Try a TrialPatent Expiration:Jul 28, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrength68MG/IMPLANT
Approval Date:May 31, 2011TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:May 31, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Sep 28, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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.