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Orange Book drug · Generic (ANDA)

Buprenorphine Hydrochloride And Naloxone Hydrochloride

Buprenorphine Hydrochloride; Naloxone Hydrochloride

ANDA 203326 2 strengths Hikma
Approved
Jun 27, 2014
Strengths
2
Listed patents
0
Applications
20

What does the FDA Orange Book show for Buprenorphine Hydrochloride And Naloxone Hydrochloride?

Buprenorphine Hydrochloride And Naloxone Hydrochloride contains Buprenorphine Hydrochloride; Naloxone Hydrochloride and appears in 20 FDA Orange Book applications. ANDA 203326 is the lead filing, with 2 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
20; lead ANDA 203326

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Hikma Pharmaceuticals USA 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
RS

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

TE codes
AB

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

Listed patents
0

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 2MG BASE;EQ 0.5MG BASETABLETSUBLINGUALPrescriptionAB
None posted
002EQ 8MG BASE;EQ 2MG BASETABLETSUBLINGUALPrescriptionAB
RS

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

Hikma Pharmaceuticals USA Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 203326.

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

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

0 other ANDAs and 5 other NDAs found

0 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

ANDA 203326 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue ANDA-203326

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 · ANDA 203326
TE AB
Strength
EQ 2MG BASE;EQ 0.5MG BASE
Dosage form
TABLET
Route
SUBLINGUAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 3 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Dosage form

TABLET

Route

SUBLINGUAL

TE code

AB

Application

ANDA 203326

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

No

Reference standard (RS)

No

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Other FDA applications for Buprenorphine Hydrochloride And Naloxone Hydrochloride

19 additional filings · 19 generic

The FDA has approved 20 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Buprenorphine Hydrochloride And Naloxone Hydrochloride, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
ANDA 091149Teva Pharms USASep 08, 20142—Discontinued
ANDA 091422Actavis ElizabethFeb 22, 20132ABPrescription
ANDA 201633Sun PharmAug 05, 20162ABPrescription
ANDA 203136Amneal PharmsFeb 22, 20132ABPrescription
ANDA 204431EthypharmOct 16, 20152ABPrescription
ANDA 205022Lannett Co IncSep 19, 20162ABPrescription
ANDA 205299DR Reddys Labs SaJun 14, 20182ABPrescription
ANDA 205601Rhodes PharmsMar 30, 20202ABPrescription
ANDA 205806DR Reddys Labs SaJun 14, 20182ABPrescription
ANDA 205954AlvogenJan 24, 20194ABPrescription
ANDA 206953DR Reddys Labs SaJul 17, 20202—Discontinued
ANDA 207000Specgx LLCDec 13, 20172ABPrescription
ANDA 207607Mylan TechnologiesJun 14, 20182ABPrescription
ANDA 209069Wes Pharma IncJul 17, 20202ABPrescription
ANDA 211785Mylan TechnologiesApr 17, 20202ABPrescription
ANDA 212756Difgen PharmsFeb 13, 20254ABPrescription
ANDA 214930Alkem Labs LtdJun 15, 20212ABPrescription
ANDA 219727Ascent Pharms IncDec 15, 20252ABPrescription
ANDA 219850Ascent Pharms IncJan 21, 20264ABPrescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Buprenorphine Hydrochloride; Naloxone Hydrochloride

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.

Buprenorphine Hydrochloride And Naloxone Hydrochloride: 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 ANDA 203326 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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