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Orange Book drug · Brand (NDA)

Xyosted (autoinjector)

Testosterone Enanthate

RLDNDA 209863 3 strengths Antares Pharma Inc
Approved
Sep 28, 2018
Strengths
3
Listed patents
24

What does the FDA Orange Book show for Xyosted (autoinjector)?

Xyosted (autoinjector) contains Testosterone Enanthate and is the new drug FDA Orange Book record for NDA 209863. The application has 3 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 209863

New drug application identity from the Orange Book snapshot.

Application holder
Antares Pharma Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
3

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
24

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
00150MG/0.5ML (50MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
00275MG/0.5ML (75MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS
003100MG/0.5ML (100MG/0.5ML)SOLUTIONSUBCUTANEOUSPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Antares Pharma Inc

The Orange Book identifies this organization as the applicant responsible for NDA 209863.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

3 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

18 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Aug 30, 2038. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

7 other ANDAs and 1 other NDA found

3 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 209863 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Subcutaneous

Testosterone Enanthate

1 application
Product rows
3
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-209863

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

3 approved presentations · NDA 209863
RLDRS
Strength
50MG/0.5ML (50MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 11 mo ago

  2. Patent 10478560 expires

    Listed drug product patent expiration.

    6 mo ago

  3. Patent 11446441 expires

    Listed drug product patent expiration.

    6 mo ago

  4. Patent 8562564 expires

    Listed drug product patent expiration.

    6 mo ago

  5. Patent 9180259 expires

    Listed drug product patent expiration.

    6 mo ago

  6. Patent 9533102 expires

    Listed drug product patent expiration.

    6 mo ago

  7. Patent 9629959 expires

    Listed drug product patent expiration.

    6 mo ago

  8. Today

  9. Patent 8021335 expires

    Listed drug product patent expiration.

    in 2 mo

  10. Patent 11497753 expires

    Listed drug product patent expiration.

    in 3 yr 8 mo

  11. Patent 10279131 expires

    Listed drug product patent expiration.

    in 5 yr 1 mo

  12. Patent 10357609 expires

    Listed drug product patent expiration.

    in 5 yr 2 mo

  13. Patent 10905827 expires

    Listed drug product patent expiration.

    in 5 yr 2 mo

  14. Patent 11446440 expires

    Listed drug product patent expiration.

    in 5 yr 2 mo

  15. Patent 10821072 expires

    Listed drug product patent expiration.

    in 7 yr

  16. Patent 11844804 expires

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

    in 7 yr

  17. Patent 10881798 expires

    Listed drug product patent expiration.

    in 7 yr 8 mo

  18. Patent 11160751 expires

    Listed drug product patent expiration.

    in 8 yr 4 mo

  19. Patent 10238662 expires

    Listed drug product patent expiration.

    in 8 yr 8 mo

  20. Patent 10912782 expires

    Listed drug product patent expiration.

    in 8 yr 8 mo

  21. Patent 11813435 expires

    Listed drug product patent expiration.

    in 8 yr 9 mo

  22. Patent 12629483 expires

    Listed drug product patent expiration.

    in 9 yr 2 mo

  23. Patent 11191908 expires

    Listed drug product patent expiration.

    in 9 yr 4 mo

  24. Patent 9744302 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  25. Patent 9950125 expires

    Listed drug product patent expiration.

    in 10 yr 3 mo

  26. Patent 10646495 expires

    Listed drug product patent expiration.

    in 12 yr 3 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 10478560: 2026-01-24Patent 10478560Patent 11446441: 2026-01-24Patent 11446441Patent 8562564: 2026-01-24Patent 8562564Patent 9180259: 2026-01-24Patent 9180259Patent 9533102: 2026-01-24Patent 9533102Patent 9629959: 2026-01-24Patent 9629959Patent 8021335: 2026-10-04Patent 8021335Patent 11497753: 2030-03-19Patent 11497753Patent 10279131: 2031-07-31Patent 10279131Patent 10357609: 2031-08-21Patent 10357609Patent 10905827: 2031-08-21Patent 10905827Patent 11446440: 2031-08-21Patent 11446440Patent 10821072: 2033-06-04Patent 10821072Patent 11844804: 2033-06-04Patent 11844804Patent 10881798: 2034-02-11Patent 10881798Patent 11160751: 2034-10-07Patent 11160751Patent 10238662: 2035-02-19Patent 10238662Patent 10912782: 2035-02-19Patent 10912782Patent 11813435: 2035-02-25Patent 11813435Patent 12629483: 2035-08-07Patent 12629483Patent 11191908: 2035-10-18Patent 11191908Patent 9744302: 2035-11-19Patent 9744302Patent 9950125: 2036-09-04Patent 9950125Patent 10646495: 2038-08-30Patent 10646495
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

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

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
104785606 mo ago
Product
114464416 mo ago
Product
85625646 mo ago
Product
91802596 mo ago
Product
95331026 mo ago
Product
96299596 mo ago
Product
8021335in 2 mo
Product
11497753in 3 yr 8 mo
Product
10279131in 5 yr 1 mo
Product
10357609in 5 yr 2 mo
Product
10905827in 5 yr 2 mo
Product
11446440in 5 yr 2 mo
Product
10821072in 7 yr
ProductU-2418
11844804in 7 yr
U-2418
10881798in 7 yr 8 mo
Product
11160751in 8 yr 4 mo
ProductU-2418
10238662in 8 yr 8 mo
ProductU-2418
10912782in 8 yr 8 mo
ProductU-2418
11813435in 8 yr 9 mo
Product
12629483in 9 yr 2 mo
Product
11191908in 9 yr 4 mo
Product
9744302in 9 yr 5 mo
Product
9950125in 10 yr 3 mo
ProductU-2418
10646495in 12 yr 3 mo
Product

Active-ingredient family

Brand + generics

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

View full Testosterone Enanthate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Xyosted (autoinjector): frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 209863 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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