Skip to content
Assyro AI
Orange Book drug · Brand (NDA)

Zubsolv

Buprenorphine Hydrochloride; Naloxone Hydrochloride

RLDNDA 204242 6 strengths Edenbridge Pharms
Approved
Jul 03, 2013
Strengths
6
Listed patents
10

What does the FDA Orange Book show for Zubsolv?

Zubsolv contains Buprenorphine Hydrochloride; Naloxone Hydrochloride and is the new drug FDA Orange Book record for NDA 204242. The application has 6 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 204242

New drug application identity from the Orange Book snapshot.

Application holder
Edenbridge Pharmaceuticals LLC Dba Dexcel Pharma USA

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

Product presentations
6

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
10

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
001EQ 1.4MG BASE;EQ 0.36MG BASETABLETSUBLINGUALPrescriptionNone posted
RLD
002EQ 5.7MG BASE;EQ 1.4MG BASETABLETSUBLINGUALPrescriptionNone posted
RLD
003EQ 8.6MG BASE;EQ 2.1MG BASETABLETSUBLINGUALPrescriptionNone posted
RLD
004EQ 11.4MG BASE;EQ 2.9MG BASETABLETSUBLINGUALPrescriptionNone posted
RLDRS
005EQ 2.9MG BASE;EQ 0.71MG BASETABLETSUBLINGUALPrescriptionNone posted
RLD
006EQ 0.7MG BASE;EQ 0.18MG BASETABLETSUBLINGUALPrescriptionNone posted
RLD

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

Edenbridge Pharmaceuticals LLC Dba Dexcel Pharma USA

The Orange Book identifies this organization as the applicant responsible for NDA 204242.

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

6 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

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

The latest future date recorded across those files is Sep 18, 2032. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

20 other ANDAs and 4 other NDAs found

18 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 204242 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Sublingual

Buprenorphine Hydrochloride; Naloxone Hydrochloride

15 applications
Product rows
34
Active applications
12
Active with AB row
11
Suboxone · NDA 020733Buprenorphine Hydrochloride And Naloxone Hydrochloride · ANDA 219727Buprenorphine Hydrochloride And Naloxone Hydrochloride · ANDA 214930Buprenorphine Hydrochloride And Naloxone Hydrochloride · ANDA 206953Buprenorphine Hydrochloride And Naloxone Hydrochloride · ANDA 209069Buprenorphine Hydrochloride And Naloxone Hydrochloride · ANDA 205601

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-204242

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

6 approved presentations · NDA 204242
RLD
Strength
EQ 1.4MG BASE;EQ 0.36MG BASE
Dosage form
TABLET
Route
SUBLINGUAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    13 yr 3 mo ago

  2. Today

  3. Patent 8658198 expires

    Listed drug product patent expiration.

    in 1 yr 5 mo

  4. Patent 8470361 expires

    Listed drug product patent expiration.

    in 3 yr 11 mo

  5. Patent 10946010 expires

    Listed drug product patent expiration.

    in 6 yr 3 mo

  6. Patent 11020388 expires

    Listed drug product patent expiration.

    in 6 yr 3 mo

  7. Patent 11433066 expires

    Listed method-of-use patent (U-3131) expiration.

    in 6 yr 3 mo

  8. Patent 8940330 expires

    Listed drug product patent expiration.

    in 6 yr 3 mo

  9. Patent 9259421 expires

    Listed drug product patent expiration.

    in 6 yr 3 mo

  10. Patent 9439900 expires

    Listed drug product patent expiration.

    in 6 yr 3 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033TodayPatent 8658198: 2027-12-03Patent 8658198Patent 8470361: 2030-05-22Patent 8470361Patent 10946010: 2032-09-18Patent 10946010Patent 11020388: 2032-09-18Patent 11020388Patent 11433066: 2032-09-18Patent 11433066Patent 8940330: 2032-09-18Patent 8940330Patent 9259421: 2032-09-18Patent 9259421Patent 9439900: 2032-09-18Patent 9439900
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Strength

EQ 1.4MG BASE;EQ 0.36MG BASE

Dosage form

TABLET

Route

SUBLINGUAL

TE code

Not listed

Application

NDA 204242

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8658198in 1 yr 5 mo
ProductU-1494
8470361in 3 yr 11 mo
ProductU-1425
10946010in 6 yr 3 mo
Product
11020388in 6 yr 3 mo
ProductU-3131
11433066in 6 yr 3 mo
U-3131
8940330in 6 yr 3 mo
Product
9259421in 6 yr 3 mo
Product
9439900in 6 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 Buprenorphine Hydrochloride; Naloxone Hydrochloride 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.

Zubsolv: 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 204242 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

Related FDA reference tools

Agent CTA Background

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

Book a Demo