Assyro AI

Orange Book product · Brand (NDA)

XYOSTED (AUTOINJECTOR)

TESTOSTERONE ENANTHATE

Brand (NDA)NDA 209863RX ANTARES PHARMA INC

At a glance

Sep 28, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

24

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 28, 2018

    7 yr 10 mo ago

  2. Patent 10478560 expires

    Listed drug product patent expiration.

    Jan 24, 2026

    5 mo ago

  3. Patent 11446441 expires

    Listed drug product patent expiration.

    Jan 24, 2026

    5 mo ago

  4. Patent 8562564 expires

    Listed drug product patent expiration.

    Jan 24, 2026

    5 mo ago

  5. Patent 9180259 expires

    Listed drug product patent expiration.

    Jan 24, 2026

    5 mo ago

  6. Patent 9533102 expires

    Listed drug product patent expiration.

    Jan 24, 2026

    5 mo ago

  7. Patent 9629959 expires

    Listed drug product patent expiration.

    Jan 24, 2026

    5 mo ago

  8. Today

  9. Patent 8021335 expires

    Listed drug product patent expiration.

    Oct 04, 2026

    in 4 mo

  10. Patent 11497753 expires

    Listed drug product patent expiration.

    Mar 19, 2030

    in 3 yr 10 mo

  11. Patent 10279131 expires

    Listed drug product patent expiration.

    Jul 31, 2031

    in 5 yr 2 mo

  12. Patent 10357609 expires

    Listed drug product patent expiration.

    Aug 21, 2031

    in 5 yr 3 mo

  13. Patent 10905827 expires

    Listed drug product patent expiration.

    Aug 21, 2031

    in 5 yr 3 mo

  14. Patent 11446440 expires

    Listed drug product patent expiration.

    Aug 21, 2031

    in 5 yr 3 mo

  15. Patent 10821072 expires

    Listed drug product patent expiration.

    Jun 04, 2033

    in 7 yr 1 mo

  16. Patent 11844804 expires

    Listed method-of-use patent (U-2418) expiration.

    Jun 04, 2033

    in 7 yr 1 mo

  17. Patent 10881798 expires

    Listed drug product patent expiration.

    Feb 11, 2034

    in 7 yr 9 mo

  18. Patent 11160751 expires

    Listed drug product patent expiration.

    Oct 07, 2034

    in 8 yr 5 mo

  19. Patent 10238662 expires

    Listed drug product patent expiration.

    Feb 19, 2035

    in 8 yr 10 mo

  20. Patent 10912782 expires

    Listed drug product patent expiration.

    Feb 19, 2035

    in 8 yr 10 mo

  21. Patent 11813435 expires

    Listed drug product patent expiration.

    Feb 25, 2035

    in 8 yr 10 mo

  22. Patent 12629483 expires

    Listed drug product patent expiration.

    Aug 07, 2035

    in 9 yr 3 mo

  23. Patent 11191908 expires

    Listed drug product patent expiration.

    Oct 18, 2035

    in 9 yr 6 mo

  24. Patent 9744302 expires

    Listed drug product patent expiration.

    Nov 19, 2035

    in 9 yr 7 mo

  25. Patent 9950125 expires

    Listed drug product patent expiration.

    Sep 04, 2036

    in 10 yr 4 mo

  26. Patent 10646495 expires

    Listed drug product patent expiration.

    Aug 30, 2038

    in 12 yr 5 mo

Pharmaceutical detail

Active ingredient

TESTOSTERONE ENANTHATE

Strength

50MG/0.5ML (50MG/0.5ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 209863

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (24)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10478560Jan 24, 20265 mo ago
Product
11446441Jan 24, 20265 mo ago
Product
8562564Jan 24, 20265 mo ago
Product
9180259Jan 24, 20265 mo ago
Product
9533102Jan 24, 20265 mo ago
Product
9629959Jan 24, 20265 mo ago
Product
8021335Oct 04, 2026in 4 mo
Product
11497753Mar 19, 2030in 3 yr 10 mo
Product
10279131Jul 31, 2031in 5 yr 2 mo
Product
10357609Aug 21, 2031in 5 yr 3 mo
Product
10905827Aug 21, 2031in 5 yr 3 mo
Product
11446440Aug 21, 2031in 5 yr 3 mo
Product
10821072Jun 04, 2033in 7 yr 1 mo
ProductU-2418
11844804Jun 04, 2033in 7 yr 1 mo
U-2418
10881798Feb 11, 2034in 7 yr 9 mo
Product
11160751Oct 07, 2034in 8 yr 5 mo
ProductU-2418
10238662Feb 19, 2035in 8 yr 10 mo
ProductU-2418
10912782Feb 19, 2035in 8 yr 10 mo
ProductU-2418
11813435Feb 25, 2035in 8 yr 10 mo
Product
12629483Aug 07, 2035in 9 yr 3 mo
Product
11191908Oct 18, 2035in 9 yr 6 mo
Product
9744302Nov 19, 2035in 9 yr 7 mo
Product
9950125Sep 04, 2036in 10 yr 4 mo
ProductU-2418
10646495Aug 30, 2038in 12 yr 5 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.