testosterone enanthate · Antares Pharma Inc · NDA 209863

Xyosted (Autoinjector)

Earliest generic entry, as listed · earliest of 3 marketed strengths
4 Sep 2036

Blocked by patent: US 9950125.

Listed patents · 16 unexpired

PatentClaimsExpires
US 9950125product, use U-24184 Sep 2036
US 9744302product19 Nov 2035
US 11191908product18 Oct 2035
US 12629483product7 Aug 2035
US 11813435product25 Feb 2035
US 10238662product, use U-241819 Feb 2035
US 10912782product, use U-241819 Feb 2035
US 11160751product, use U-24187 Oct 2034
US 10881798product11 Feb 2034
US 10821072product, use U-24184 Jun 2033
US 11844804use U-24184 Jun 2033
US 10357609product21 Aug 2031
US 10905827product21 Aug 2031
US 11446440product21 Aug 2031
US 10279131product31 Jul 2031
US 11497753product19 Mar 2030

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 3

NDA · productFormStrengthListed expiry
209863 · 001 · RLDsolution, subcutaneous50MG/0.5ML (50MG/0.5ML)4 Sep 2036
209863 · 002 · RLDsolution, subcutaneous75MG/0.5ML (75MG/0.5ML)4 Sep 2036
209863 · 003 · RLDsolution, subcutaneous100MG/0.5ML (100MG/0.5ML)4 Sep 2036
Expired or delisted (7)
  • US 8021335 · product · 4 Oct 2026
  • US 10478560 · product · 24 Jan 2026
  • US 11446441 · product · 24 Jan 2026
  • US 8562564 · product · 24 Jan 2026
  • US 9180259 · product · 24 Jan 2026
  • US 9533102 · product · 24 Jan 2026
  • US 9629959 · product · 24 Jan 2026