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# Organon Wants Generic Nexplanon Restrictions
- URL: https://www.fdaweb.com/organon-wants-generic-nexplanon-restrictions/
- Published: 2024-03-21T12:00:00.000Z
- Updated: 2026-09-14T14:26:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156603

Organon is asking FDA to impose requirements on any ANDAs that cite its Nexplanon (etonogestrel implant) as the reference-listed drug. The company’s 3/1 [petition](https://downloads.regulations.gov/FDA-2024-P-1378-0001/attachment%5F2.pdf?ref=fdaweb.com) asks that the agency specifically:

- require that an ANDA applicant establish bioequivalence (BE) of the generic drug through **(1)** an *in vivo* BE study with pharmacokinetic endpoints evaluating the full duration of the approved, labeled in-use period of Nexplanon, which is the duration of use for which the generic contraceptive implant also would be labeled; or **(2)** a validated *in vivo-in vitro* correlation model covering the labeled duration of use; and require that the ANDA applicant conduct comparative dissolution testing profiles in three different media and data on dissolution profile comparison in water;
- to the extent that FDA determines that a proposed ANDA product does not need to demonstrate BE as described above, it should require a demonstration of physiochemical and structural sameness between the proposed ANDA product and the reference-listed drug;
- require generic etonogestrel implants to have equivalent device constituents;
- require an ANDA applicant to implement measures to ensure appropriate training on the use of the generic product; and
- revise the agency’s product-specific guidance for etonogestrel implants to reflect the above requirements.

Organon says that while it supports access to safe and effective generic contraceptive products, including generic etonogestrel implants, it has concerns that an 8/2022 FDA draft product-specific guidance on etonogestrel will not ensure the approval of safe and effective generic etonogestrel implants.