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Orange Book drug · Brand (NDA)

Sublocade

Buprenorphine

RLDNDA 209819 2 strengths Indivior
Approved
Nov 30, 2017
Strengths
2
Listed patents
13

What does the FDA Orange Book show for Sublocade?

Sublocade contains Buprenorphine and is the new drug FDA Orange Book record for NDA 209819. The application has 2 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 209819

New drug application identity from the Orange Book snapshot.

Application holder
Indivior Inc

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

Product presentations
2

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
13

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

Exclusivity records
1

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
001100MG/0.5ML (100MG/0.5ML)SOLUTION, EXTENDED RELEASESUBCUTANEOUSPrescriptionNone posted
RLD
002300MG/1.5ML (200MG/ML)SOLUTION, EXTENDED RELEASESUBCUTANEOUSPrescriptionNone 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

Indivior Inc

The Orange Book identifies this organization as the applicant responsible for NDA 209819.

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

2 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

13 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Jun 22, 2038. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

5 other ANDAs and 2 other NDAs found

4 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 209819 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, Extended Release · Subcutaneous

Buprenorphine

2 applications
Product rows
9
Active applications
2
Active with AB row
0
Brixadi · NDA 210136

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-209819

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

2 approved presentations · NDA 209819
RLD
Strength
100MG/0.5ML (100MG/0.5ML)
Dosage form
SOLUTION, EXTENDED RELEASE
Route
SUBCUTANEOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 9 mo ago

  2. Today

  3. Exclusivity ends · M-314

    New use / labeling-change exclusivity (3 years)

    in 1 yr 7 mo

  4. Patent 10198218 expires

    Listed method-of-use patent (U-2489) expiration.

    in 4 yr 11 mo

  5. Patent 10592168 expires

    Listed method-of-use patent (U-2489) expiration.

    in 4 yr 11 mo

  6. Patent 9272044 expires

    Listed method-of-use patent (U-2176) expiration.

    in 4 yr 11 mo

  7. Patent 9272044 expires

    Listed method-of-use patent (U-2209) expiration.

    in 4 yr 11 mo

  8. Patent 9272044 expires

    Listed method-of-use patent (U-2178) expiration.

    in 4 yr 11 mo

  9. Patent 9272044 expires

    Listed method-of-use patent (U-2177) expiration.

    in 4 yr 11 mo

  10. Patent 9498432 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  11. Patent 9782402 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  12. Patent 9782402 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  13. Patent 9782402 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  14. Patent 9782402 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  15. Patent 9827241 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  16. Patent 9827241 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  17. Patent 9827241 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  18. Patent 9827241 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  19. Patent 9827241 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  20. Patent 10558394 expires

    Listed drug product patent expiration.

    in 5 yr

  21. Patent 8975270 expires

    Listed drug product patent expiration.

    in 5 yr 2 mo

  22. Patent 8975270 expires

    Listed drug product patent expiration.

    in 5 yr 2 mo

  23. Patent 8921387 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  24. Patent 8921387 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  25. Patent 11000520 expires

    Listed method-of-use patent (U-3111) expiration.

    in 9 yr 5 mo

  26. Patent 11839611 expires

    Listed method-of-use patent (U-3111) expiration.

    in 9 yr 5 mo

  27. Patent 12622904 expires

    Listed method-of-use patent (U-4528) expiration.

    in 9 yr 5 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033203420352036TodayExclusivity M-314: 2028-02-21Exclusivity M-314Patent 10198218: 2031-06-06Patent 10198218Patent 10592168: 2031-06-06Patent 10592168Patent 9272044: 2031-06-06Patent 9272044Patent 9272044: 2031-06-06Patent 9272044Patent 9272044: 2031-06-06Patent 9272044Patent 9272044: 2031-06-06Patent 9272044Patent 9498432: 2031-06-06Patent 9498432Patent 9782402: 2031-06-06Patent 9782402Patent 9782402: 2031-06-06Patent 9782402Patent 9782402: 2031-06-06Patent 9782402Patent 9782402: 2031-06-06Patent 9782402Patent 9827241: 2031-06-06Patent 9827241Patent 9827241: 2031-06-06Patent 9827241Patent 9827241: 2031-06-06Patent 9827241Patent 9827241: 2031-06-06Patent 9827241Patent 9827241: 2031-06-06Patent 9827241Patent 10558394: 2031-06-25Patent 10558394Patent 8975270: 2031-09-05Patent 8975270Patent 8975270: 2031-09-05Patent 8975270Patent 8921387: 2032-01-06Patent 8921387Patent 8921387: 2032-01-06Patent 8921387Patent 11000520: 2035-11-06Patent 11000520Patent 11839611: 2035-11-06Patent 11839611Patent 12622904: 2035-11-06Patent 12622904
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BUPRENORPHINE

Strength

100MG/0.5ML (100MG/0.5ML)

Dosage form

SOLUTION, EXTENDED RELEASE

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 209819

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • M-314New use / labeling-change exclusivity (3 years)

    in 1 yr 7 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10198218in 4 yr 11 mo
U-2489
10592168in 4 yr 11 mo
U-2489
9272044in 4 yr 11 mo
U-2176
9272044in 4 yr 11 mo
U-2209
9272044in 4 yr 11 mo
U-2178
9272044in 4 yr 11 mo
U-2177
9498432in 4 yr 11 mo
ProductU-2179
9782402in 4 yr 11 mo
ProductU-2180
9782402in 4 yr 11 mo
ProductU-2176
9782402in 4 yr 11 mo
ProductU-2208
9782402in 4 yr 11 mo
ProductU-2207
9827241in 4 yr 11 mo
ProductU-2206
9827241in 4 yr 11 mo
ProductU-2211
9827241in 4 yr 11 mo
ProductU-2181
9827241in 4 yr 11 mo
ProductU-2210
9827241in 4 yr 11 mo
ProductU-2174
10558394in 5 yr
Product
8975270in 5 yr 2 mo
ProductU-2206
8975270in 5 yr 2 mo
ProductU-2175
8921387in 5 yr 6 mo
ProductU-2174
8921387in 5 yr 6 mo
ProductU-2173
11000520in 9 yr 5 mo
U-3111
11839611in 9 yr 5 mo
U-3111
12622904in 9 yr 5 mo
U-4528

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 Buprenorphine 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.

Sublocade: 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 209819 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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