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Orange Book drug · Brand (NDA)

Zynrelef Kit

Bupivacaine; Meloxicam

RLDNDA 211988 4 strengths Heron Theraps Inc
Approved
May 12, 2021
Strengths
4
Listed patents
16

What does the FDA Orange Book show for Zynrelef Kit?

Zynrelef Kit contains Bupivacaine; Meloxicam and is the new drug FDA Orange Book record for NDA 211988. The application has 4 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 211988

New drug application identity from the Orange Book snapshot.

Application holder
Heron Therapeutics Inc

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

Product presentations
4

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Discontinued and 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
16

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
00160MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)SOLUTION, EXTENDED RELEASEPERIARTICULARDiscontinuedNone posted
RLD
002200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)SOLUTION, EXTENDED RELEASEPERIARTICULARPrescriptionNone posted
RLDRS
003300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)SOLUTION, EXTENDED RELEASEPERIARTICULARDiscontinuedNone posted
RLD
004400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)SOLUTION, EXTENDED RELEASEPERIARTICULARPrescriptionNone 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

Heron Therapeutics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 211988.

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

Status varies by presentation: 2 on the Discontinued Drug Product List and 2 prescription

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

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

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

The latest future date recorded across those files is Apr 21, 2036. 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 211988 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 · Periarticular

Bupivacaine; Meloxicam

1 application
Product rows
4
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-211988

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

4 approved presentations · NDA 211988
RLDDiscontinued
Strength
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)
Dosage form
SOLUTION, EXTENDED RELEASE
Route
PERIARTICULAR
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    5 yr 3 mo ago

  2. Today

  3. Exclusivity ends · I-933

    New indication exclusivity (3 years)

    in 6 mo

  4. Patent 10398686 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

  5. Patent 11253504 expires

    Listed method-of-use patent (U-3118) expiration.

    in 7 yr 9 mo

  6. Patent 9592227 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

  7. Patent 9744163 expires

    Listed drug product patent expiration.

    in 7 yr 9 mo

  8. Patent 9913909 expires

    Listed method-of-use patent (U-3118) expiration.

    in 7 yr 9 mo

  9. Patent 10098957 expires

    Listed method-of-use patent (U-3118) expiration.

    in 8 yr 10 mo

  10. Patent 10213510 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  11. Patent 10632199 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  12. Patent 10898575 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  13. Patent 10980886 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  14. Patent 11083730 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  15. Patent 11083797 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  16. Patent 11413350 expires

    Listed method-of-use patent (U-3417) expiration.

    in 8 yr 10 mo

  17. Patent 9694079 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  18. Patent 9801945 expires

    Listed drug product patent expiration.

    in 8 yr 10 mo

  19. Patent 11844837 expires

    Listed method-of-use patent (U-3417) expiration.

    in 9 yr 11 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayExclusivity I-933: 2027-01-23Exclusivity I-933Patent 10398686: 2034-03-13Patent 10398686Patent 11253504: 2034-03-13Patent 11253504Patent 9592227: 2034-03-13Patent 9592227Patent 9744163: 2034-03-13Patent 9744163Patent 9913909: 2034-03-13Patent 9913909Patent 10098957: 2035-04-20Patent 10098957Patent 10213510: 2035-04-20Patent 10213510Patent 10632199: 2035-04-20Patent 10632199Patent 10898575: 2035-04-20Patent 10898575Patent 10980886: 2035-04-20Patent 10980886Patent 11083730: 2035-04-20Patent 11083730Patent 11083797: 2035-04-20Patent 11083797Patent 11413350: 2035-04-20Patent 11413350Patent 9694079: 2035-04-20Patent 9694079Patent 9801945: 2035-04-20Patent 9801945Patent 11844837: 2036-04-21Patent 11844837
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BUPIVACAINE; MELOXICAM

Strength

60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)

Dosage form

SOLUTION, EXTENDED RELEASE

Route

PERIARTICULAR

TE code

Not listed

Application

NDA 211988

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • I-933New indication exclusivity (3 years)

    in 6 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10398686in 7 yr 9 mo
Product
11253504in 7 yr 9 mo
U-3118
9592227in 7 yr 9 mo
ProductU-3118
9744163in 7 yr 9 mo
Product
9913909in 7 yr 9 mo
U-3118
10098957in 8 yr 10 mo
U-3118
10213510in 8 yr 10 mo
ProductU-3118
10632199in 8 yr 10 mo
ProductU-3118
10898575in 8 yr 10 mo
ProductU-3118
10980886in 8 yr 10 mo
Product
11083730in 8 yr 10 mo
ProductU-3118
11083797in 8 yr 10 mo
ProductU-3118
11413350in 8 yr 10 mo
U-3417
9694079in 8 yr 10 mo
ProductU-3118
9801945in 8 yr 10 mo
ProductU-3118
11844837in 9 yr 11 mo
U-3417

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 Bupivacaine; Meloxicam 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.

Zynrelef Kit: 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 211988 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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