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Orange Book drug · Brand (NDA)

Giapreza

Angiotensin II Acetate

RLDNDA 209360 3 strengths LA Jolla Pharma
Approved
Dec 21, 2017
Strengths
3
Listed patents
11

What does the FDA Orange Book show for Giapreza?

Giapreza contains Angiotensin II Acetate and is the new drug FDA Orange Book record for NDA 209360. The application has 3 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 209360

New drug application identity from the Orange Book snapshot.

Application holder
LA Jolla Pharma LLC

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

Product presentations
3

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

Marketing categories
Prescription and Discontinued

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
AP

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 2.5MG BASE/ML (EQ 2.5MG BASE/ML)SOLUTIONINTRAVENOUSPrescriptionAP
RLDRS
002EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)SOLUTIONINTRAVENOUSDiscontinuedNone posted
RLD
003EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)SOLUTIONINTRAVENOUSPrescriptionNone 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

LA Jolla Pharma LLC

The Orange Book identifies this organization as the applicant responsible for NDA 209360.

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 prescription and 1 on the Discontinued Drug Product List

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

TE code AP across rated presentations

An AP code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group. 2 presentations in the application have no posted TE 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 06, 2037. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

1 other ANDA and 0 other NDAs found

1 of the related ANDA application is 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 209360 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 NDA-209360

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

3 approved presentations · NDA 209360
TE APRLDRS
Strength
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 9 mo ago

  2. Today

  3. Patent 10335451 expires

    Listed method-of-use patent (U-2581) expiration.

    in 3 yr 5 mo

  4. Patent 10500247 expires

    Listed method-of-use patent (U-2681) expiration.

    in 3 yr 5 mo

  5. Patent 10500247 expires

    Listed method-of-use patent (U-2680) expiration.

    in 3 yr 5 mo

  6. Patent 10548943 expires

    Listed method-of-use patent (U-2740) expiration.

    in 3 yr 5 mo

  7. Patent 10548943 expires

    Listed method-of-use patent (U-2739) expiration.

    in 3 yr 5 mo

  8. Patent 9867863 expires

    Listed method-of-use patent (U-2231) expiration.

    in 3 yr 5 mo

  9. Patent 9572856 expires

    Listed method-of-use patent (U-2221) expiration.

    in 5 yr 1 mo

  10. Patent 10028995 expires

    Listed method-of-use patent (U-2338) expiration.

    in 8 yr 6 mo

  11. Patent 10493124 expires

    Listed method-of-use patent (U-2679) expiration.

    in 8 yr 6 mo

  12. Patent 11096983 expires

    Listed method-of-use patent (U-3211) expiration.

    in 8 yr 6 mo

  13. Patent 11096983 expires

    Listed method-of-use patent (U-3212) expiration.

    in 8 yr 6 mo

  14. Patent 11559559 expires

    Listed method-of-use patent (U-3514) expiration.

    in 8 yr 6 mo

  15. Patent 9220745 expires

    Listed method-of-use patent (U-2218) expiration.

    in 8 yr 6 mo

  16. Patent 9220745 expires

    Listed method-of-use patent (U-2217) expiration.

    in 8 yr 6 mo

  17. Patent 11219662 expires

    Listed method-of-use patent (U-3262) expiration.

    in 10 yr 7 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 10335451: 2029-12-16Patent 10335451Patent 10500247: 2029-12-16Patent 10500247Patent 10500247: 2029-12-16Patent 10500247Patent 10548943: 2029-12-16Patent 10548943Patent 10548943: 2029-12-16Patent 10548943Patent 9867863: 2029-12-16Patent 9867863Patent 9572856: 2031-07-18Patent 9572856Patent 10028995: 2034-12-18Patent 10028995Patent 10493124: 2034-12-18Patent 10493124Patent 11096983: 2034-12-18Patent 11096983Patent 11096983: 2034-12-18Patent 11096983Patent 11559559: 2034-12-18Patent 11559559Patent 9220745: 2034-12-18Patent 9220745Patent 9220745: 2034-12-18Patent 9220745Patent 11219662: 2037-01-06Patent 11219662
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

ANGIOTENSIN II ACETATE

Strength

EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

NDA 209360

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
10335451in 3 yr 5 mo
U-2581
10500247in 3 yr 5 mo
U-2681
10500247in 3 yr 5 mo
U-2680
10548943in 3 yr 5 mo
U-2740
10548943in 3 yr 5 mo
U-2739
9867863in 3 yr 5 mo
U-2231
9572856in 5 yr 1 mo
U-2221
10028995in 8 yr 6 mo
U-2338
10493124in 8 yr 6 mo
U-2679
11096983in 8 yr 6 mo
U-3211
11096983in 8 yr 6 mo
U-3212
11559559in 8 yr 6 mo
U-3514
9220745in 8 yr 6 mo
U-2218
9220745in 8 yr 6 mo
U-2217
11219662in 10 yr 7 mo
U-3262

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 Angiotensin II Acetate 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.

Giapreza: 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 209360 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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