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Orange Book drug · Brand (NDA)

Inomax

Nitric Oxide

RLDNDA 020845 3 strengths Mallinckrodt Ireland
Approved
Dec 23, 1999
Strengths
3
Listed patents
32

What does the FDA Orange Book show for Inomax?

Inomax contains Nitric Oxide and is the new drug FDA Orange Book record for NDA 020845. 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 020845

New drug application identity from the Orange Book snapshot.

Application holder
Mallinckrodt Pharmaceuticals Ireland Ltd

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
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
AA

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

Listed patents
32

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
002100PPMGASINHALATIONDiscontinuedNone posted
RLD
003800PPMGASINHALATIONPrescriptionAA
RLDRS
0044880PPMGASINHALATIONPrescriptionNone 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

Mallinckrodt Pharmaceuticals Ireland Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 020845.

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: 1 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

TE code AA across rated presentations

An AA 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

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

The latest future date recorded across those files is Nov 03, 2036. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

2 other ANDAs and 1 other NDA 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 020845 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-020845

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 020845
RLDDiscontinued
Strength
100PPM
Dosage form
GAS
Route
INHALATION
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    27 yr ago

  2. Today

  3. Patent 8282966 expires

    Listed method-of-use patent (U-1286) expiration.

    in 3 yr

  4. Patent 8293284 expires

    Listed method-of-use patent (U-1286) expiration.

    in 3 yr

  5. Patent 8431163 expires

    Listed method-of-use patent (U-1286) expiration.

    in 3 yr

  6. Patent 8795741 expires

    Listed method-of-use patent (U-1286) expiration.

    in 3 yr

  7. Patent 8846112 expires

    Listed method-of-use patent (U-1286) expiration.

    in 3 yr

  8. Patent 8282966*PED expires

    Listed listed patent expiration.

    in 3 yr 6 mo

  9. Patent 8293284*PED expires

    Listed listed patent expiration.

    in 3 yr 6 mo

  10. Patent 8431163*PED expires

    Listed listed patent expiration.

    in 3 yr 6 mo

  11. Patent 8795741*PED expires

    Listed listed patent expiration.

    in 3 yr 6 mo

  12. Patent 8846112*PED expires

    Listed listed patent expiration.

    in 3 yr 6 mo

  13. Patent 8291904 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  14. Patent 8573209 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  15. Patent 8573210 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  16. Patent 8776794 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  17. Patent 8776795 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  18. Patent 8291904*PED expires

    Listed listed patent expiration.

    in 5 yr

  19. Patent 8573209*PED expires

    Listed listed patent expiration.

    in 5 yr

  20. Patent 8573210*PED expires

    Listed listed patent expiration.

    in 5 yr

  21. Patent 8776794*PED expires

    Listed listed patent expiration.

    in 5 yr

  22. Patent 8776795*PED expires

    Listed listed patent expiration.

    in 5 yr

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032TodayPatent 8282966: 2029-06-30Patent 8282966Patent 8293284: 2029-06-30Patent 8293284Patent 8431163: 2029-06-30Patent 8431163Patent 8795741: 2029-06-30Patent 8795741Patent 8846112: 2029-06-30Patent 8846112Patent 8282966*PED: 2029-12-30Patent 8282966*PEDPatent 8293284*PED: 2029-12-30Patent 8293284*PEDPatent 8431163*PED: 2029-12-30Patent 8431163*PEDPatent 8795741*PED: 2029-12-30Patent 8795741*PEDPatent 8846112*PED: 2029-12-30Patent 8846112*PEDPatent 8291904: 2031-01-06Patent 8291904Patent 8573209: 2031-01-06Patent 8573209Patent 8573210: 2031-01-06Patent 8573210Patent 8776794: 2031-01-06Patent 8776794Patent 8776795: 2031-01-06Patent 8776795Patent 8291904*PED: 2031-07-06Patent 8291904*PEDPatent 8573209*PED: 2031-07-06Patent 8573209*PEDPatent 8573210*PED: 2031-07-06Patent 8573210*PEDPatent 8776794*PED: 2031-07-06Patent 8776794*PEDPatent 8776795*PED: 2031-07-06Patent 8776795*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

NITRIC OXIDE

Strength

100PPM

Dosage form

GAS

Route

INHALATION

TE code

Not listed

Application

NDA 020845

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8282966in 3 yr
U-1286
8293284in 3 yr
U-1286
8431163in 3 yr
U-1286
8795741in 3 yr
U-1286
8846112in 3 yr
U-1286
8282966*PEDin 3 yr 6 mo
8293284*PEDin 3 yr 6 mo
8431163*PEDin 3 yr 6 mo
8795741*PEDin 3 yr 6 mo
8846112*PEDin 3 yr 6 mo
8291904in 4 yr 6 mo
ProductU-1226
8573209in 4 yr 6 mo
Product
8573210in 4 yr 6 mo
ProductU-1453
8776794in 4 yr 6 mo
ProductU-1226
8776795in 4 yr 6 mo
ProductU-1226
8291904*PEDin 5 yr
8573209*PEDin 5 yr
8573210*PEDin 5 yr
8776794*PEDin 5 yr
8776795*PEDin 5 yr

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 Nitric Oxide 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.

Inomax: 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 020845 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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