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Orange Book drug · Brand (NDA)

Vabomere

Meropenem; Vaborbactam

RLDNDA 209776 Rempex
Approved
Aug 29, 2017
Strengths
1
Listed patents
10

What does the FDA Orange Book show for Vabomere?

Vabomere contains Meropenem; Vaborbactam and is the new drug FDA Orange Book record for NDA 209776. 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 209776

New drug application identity from the Orange Book snapshot.

Application holder
Rempex Pharmaceuticals Inc A Wholly Owned Sub Of Melinta Therapeutics LLC

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
10

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

Exclusivity records
2

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
0011GM/VIAL;1GM/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

Rempex Pharmaceuticals Inc A Wholly Owned Sub Of Melinta Therapeutics LLC

The Orange Book identifies this organization as the applicant responsible for NDA 209776.

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

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

The latest future date recorded across those files is May 20, 2039. 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 209776 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

Meropenem; Vaborbactam

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-209776

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 209776
RLDRS
Strength
1GM/VIAL;1GM/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    9 yr ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    4 yr ago

  3. Today

  4. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    in 1 yr 1 mo

  5. Patent 10172874 expires

    Listed drug product patent expiration.

    in 5 yr 1 mo

  6. Patent 10183034 expires

    Listed method-of-use patent (U-2490) expiration.

    in 5 yr 1 mo

  7. Patent 10561675 expires

    Listed method-of-use patent (U-2490) expiration.

    in 5 yr 1 mo

  8. Patent 11007206 expires

    Listed method-of-use patent (U-3128) expiration.

    in 5 yr 1 mo

  9. Patent 12171772 expires

    Listed drug substance patent expiration.

    in 5 yr 1 mo

  10. Patent 9694025 expires

    Listed method-of-use patent (U-2120) expiration.

    in 5 yr 1 mo

  11. Patent 8680136 expires

    Listed drug substance patent expiration.

    in 5 yr 2 mo

  12. Patent 12478606 expires

    Listed method-of-use patent (U-3421) expiration.

    in 11 yr 7 mo

  13. Patent 11376237 expires

    Listed method-of-use patent (U-3421) expiration.

    in 12 yr 11 mo

  14. Patent 12533342 expires

    Listed method-of-use patent (U-3421) expiration.

    in 13 yr

Patent & exclusivity timeline

Protection horizon
2022202420262028203020322034203620382040TodayExclusivity NCE: 2022-08-29Exclusivity NCEExclusivity GAIN: 2027-08-29Exclusivity GAINPatent 10172874: 2031-08-08Patent 10172874Patent 10183034: 2031-08-08Patent 10183034Patent 10561675: 2031-08-08Patent 10561675Patent 11007206: 2031-08-08Patent 11007206Patent 12171772: 2031-08-08Patent 12171772Patent 9694025: 2031-08-08Patent 9694025Patent 8680136: 2031-08-29Patent 8680136Patent 12478606: 2038-01-08Patent 12478606Patent 11376237: 2039-04-06Patent 11376237Patent 12533342: 2039-05-20Patent 12533342
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

MEROPENEM; VABORBACTAM

Strength

1GM/VIAL;1GM/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 209776

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    4 yr ago

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    in 1 yr 1 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10172874in 5 yr 1 mo
Product
10183034in 5 yr 1 mo
U-2490
10561675in 5 yr 1 mo
U-2490
11007206in 5 yr 1 mo
U-3128
12171772in 5 yr 1 mo
Substance
9694025in 5 yr 1 mo
U-2120
8680136in 5 yr 2 mo
SubstanceProduct
12478606in 11 yr 7 mo
U-3421
11376237in 12 yr 11 mo
U-3421
12533342in 13 yr
U-3421

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 Meropenem; Vaborbactam 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.

Vabomere: 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 209776 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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