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Orange Book drug · Brand (NDA)

Byfavo

Remimazolam Besylate

RLDNDA 212295 Acacia
Approved
Oct 06, 2020
Strengths
1
Listed patents
11

What does the FDA Orange Book show for Byfavo?

Byfavo contains Remimazolam Besylate and is the new drug FDA Orange Book record for NDA 212295. The application has 1 presentation 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 212295

New drug application identity from the Orange Book snapshot.

Application holder
Acacia Pharma Ltd

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

Product presentations
1

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
11

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 20MG BASE/VIALPOWDERINTRAVENOUSPrescriptionNone 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

Acacia Pharma Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 212295.

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

1 presentation 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

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

The latest future date recorded across those files is Jan 13, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 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

NDA 212295 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Powder · Intravenous

Remimazolam Besylate

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

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-212295

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.

Product detail

NDA 212295
RLDRS
Strength
EQ 20MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    5 yr 11 mo ago

  2. Today

  3. Patent 10472365 expires

    Listed method-of-use patent (U-2968) expiration.

    in 1 yr

  4. Patent 10961250 expires

    Listed drug product patent expiration.

    in 1 yr

  5. Patent 9777007 expires

    Listed drug product patent expiration.

    in 1 yr

  6. Patent 9914738 expires

    Listed drug product patent expiration.

    in 1 yr

  7. Patent 10052334 expires

    Listed method-of-use patent (U-2968) expiration.

    in 5 yr 4 mo

  8. Patent 10195210 expires

    Listed method-of-use patent (U-2968) expiration.

    in 5 yr 4 mo

  9. Patent 10342800 expires

    Listed method-of-use patent (U-2968) expiration.

    in 5 yr 4 mo

  10. Patent 10722522 expires

    Listed method-of-use patent (U-2968) expiration.

    in 5 yr 4 mo

  11. Patent 9737547 expires

    Listed method-of-use patent (U-2968) expiration.

    in 5 yr 4 mo

  12. Patent 9561236 expires

    Listed method-of-use patent (U-2968) expiration.

    in 6 yr 10 mo

  13. Patent 9827251 expires

    Listed method-of-use patent (U-2968) expiration.

    in 7 yr 7 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032203320342035TodayPatent 10472365: 2027-07-10Patent 10472365Patent 10961250: 2027-07-10Patent 10961250Patent 9777007: 2027-07-10Patent 9777007Patent 9914738: 2027-07-10Patent 9914738Patent 10052334: 2031-11-07Patent 10052334Patent 10195210: 2031-11-07Patent 10195210Patent 10342800: 2031-11-07Patent 10342800Patent 10722522: 2031-11-07Patent 10722522Patent 9737547: 2031-11-07Patent 9737547Patent 9561236: 2033-04-30Patent 9561236Patent 9827251: 2034-01-13Patent 9827251
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

REMIMAZOLAM BESYLATE

Strength

EQ 20MG BASE/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 212295

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
10472365in 1 yr
U-2968
10961250in 1 yr
ProductU-2968
9777007in 1 yr
Product
9914738in 1 yr
Product
10052334in 5 yr 4 mo
U-2968
10195210in 5 yr 4 mo
U-2968
10342800in 5 yr 4 mo
U-2968
10722522in 5 yr 4 mo
U-2968
9737547in 5 yr 4 mo
U-2968
9561236in 6 yr 10 mo
U-2968
9827251in 7 yr 7 mo
U-2968

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.

No other applications share this active ingredient.

View full Remimazolam Besylate 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.

Byfavo: 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 212295 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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