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Orange Book drug · Brand (NDA)

Genosyl

Nitric Oxide

RLDNDA 202860 Vero Biotech Inc
Approved
Dec 20, 2019
Strengths
1
Listed patents
14

What does the FDA Orange Book show for Genosyl?

Genosyl contains Nitric Oxide and is the new drug FDA Orange Book record for NDA 202860. 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 202860

New drug application identity from the Orange Book snapshot.

Application holder
Vero Biotech Inc

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
14

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
001800PPMGASINHALATIONPrescriptionNone 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

Vero Biotech Inc

The Orange Book identifies this organization as the applicant responsible for NDA 202860.

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

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

The latest future date recorded across those files is Jul 22, 2040. 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 202860 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-202860

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 202860
RLDRS
Strength
800PPM
Dosage form
GAS
Route
INHALATION
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    6 yr 8 mo ago

  2. Patent 8057742 expires

    Listed method-of-use patent (U-3037) expiration.

    6 mo ago

  3. Today

  4. Patent 7618594 expires

    Listed drug product patent expiration.

    in 3 mo

  5. Patent 7947227 expires

    Listed method-of-use patent (U-3037) expiration.

    in 3 mo

  6. Patent 7560076 expires

    Listed drug product patent expiration.

    in 9 mo

  7. Patent 9701538 expires

    Listed drug product patent expiration.

    in 2 yr 7 mo

  8. Patent 10926054 expires

    Listed drug product patent expiration.

    in 3 yr 1 mo

  9. Patent 8944049 expires

    Listed drug product patent expiration.

    in 3 yr 1 mo

  10. Patent 9604028 expires

    Listed method-of-use patent (U-2793) expiration.

    in 3 yr 1 mo

  11. Patent 11511252 expires

    Listed drug product patent expiration.

    in 3 yr 2 mo

  12. Patent 11103669 expires

    Listed drug product patent expiration.

    in 4 yr

  13. Patent 8607785 expires

    Listed drug product patent expiration.

    in 4 yr

  14. Patent 10737051 expires

    Listed drug product patent expiration.

    in 9 yr 4 mo

  15. Patent 10213572 expires

    Listed drug product patent expiration.

    in 9 yr 8 mo

  16. Patent 11672938 expires

    Listed method-of-use patent (U-3037) expiration.

    in 14 yr 2 mo

Patent & exclusivity timeline

Protection horizon
20262028203020322034203620382040TodayPatent 8057742: 2026-01-18Patent 8057742Patent 7618594: 2026-10-17Patent 7618594Patent 7947227: 2026-10-17Patent 7947227Patent 7560076: 2027-04-21Patent 7560076Patent 9701538: 2029-01-28Patent 9701538Patent 10926054: 2029-08-13Patent 10926054Patent 8944049: 2029-08-13Patent 8944049Patent 9604028: 2029-08-13Patent 9604028Patent 11511252: 2029-09-21Patent 11511252Patent 11103669: 2030-06-21Patent 11103669Patent 8607785: 2030-07-14Patent 8607785Patent 10737051: 2035-10-20Patent 10737051Patent 10213572: 2036-02-12Patent 10213572Patent 11672938: 2040-07-22Patent 11672938
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

NITRIC OXIDE

Strength

800PPM

Dosage form

GAS

Route

INHALATION

TE code

Not listed

Application

NDA 202860

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
80577426 mo ago
U-3037
7618594in 3 mo
Product
7947227in 3 mo
U-3037
7560076in 9 mo
Product
9701538in 2 yr 7 mo
Product
10926054in 3 yr 1 mo
Product
8944049in 3 yr 1 mo
Product
9604028in 3 yr 1 mo
U-2793
11511252in 3 yr 2 mo
Product
11103669in 4 yr
Product
8607785in 4 yr
Product
10737051in 9 yr 4 mo
Product
10213572in 9 yr 8 mo
Product
11672938in 14 yr 2 mo
U-3037

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.

Genosyl: 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 202860 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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