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Orange Book drug · Brand (NDA)

Tyrvaya

Varenicline Tartrate

RLDNDA 213978 Oyster Point Pharma
Approved
Oct 15, 2021
Strengths
1
Listed patents
11

What does the FDA Orange Book show for Tyrvaya?

Tyrvaya contains Varenicline Tartrate and is the new drug FDA Orange Book record for NDA 213978. 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 213978

New drug application identity from the Orange Book snapshot.

Application holder
Oyster Point Pharma 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
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 0.03MG BASE/SPRAYSPRAYNASALPrescriptionNone 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

Oyster Point Pharma Inc

The Orange Book identifies this organization as the applicant responsible for NDA 213978.

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

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

The latest future date recorded across those files is Oct 19, 2035. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

21 other ANDAs and 1 other NDA found

19 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 213978 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Spray · Nasal

Varenicline Tartrate

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-213978

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 213978
RLDRS
Strength
EQ 0.03MG BASE/SPRAY
Dosage form
SPRAY
Route
NASAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    4 yr 10 mo ago

  2. Today

  3. Patent 10456396 expires

    Listed drug product patent expiration.

    in 9 yr 4 mo

  4. Patent 11224598 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

  5. Patent 11903941 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

  6. Patent 11903942 expires

    Listed drug product patent expiration.

    in 9 yr 4 mo

  7. Patent 11903943 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

  8. Patent 11911380 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

  9. Patent 12576080 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

  10. Patent 9504644 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

  11. Patent 9504645 expires

    Listed drug product patent expiration.

    in 9 yr 4 mo

  12. Patent 9532944 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

  13. Patent 9597284 expires

    Listed method-of-use patent (U-1900) expiration.

    in 9 yr 4 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033203420352036TodayPatent 10456396: 2035-10-19Patent 10456396Patent 11224598: 2035-10-19Patent 11224598Patent 11903941: 2035-10-19Patent 11903941Patent 11903942: 2035-10-19Patent 11903942Patent 11903943: 2035-10-19Patent 11903943Patent 11911380: 2035-10-19Patent 11911380Patent 12576080: 2035-10-19Patent 12576080Patent 9504644: 2035-10-19Patent 9504644Patent 9504645: 2035-10-19Patent 9504645Patent 9532944: 2035-10-19Patent 9532944Patent 9597284: 2035-10-19Patent 9597284
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

VARENICLINE TARTRATE

Strength

EQ 0.03MG BASE/SPRAY

Dosage form

SPRAY

Route

NASAL

TE code

Not listed

Application

NDA 213978

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
10456396in 9 yr 4 mo
ProductU-1900
11224598in 9 yr 4 mo
U-1900
11903941in 9 yr 4 mo
U-1900
11903942in 9 yr 4 mo
Product
11903943in 9 yr 4 mo
U-1900
11911380in 9 yr 4 mo
U-1900
12576080in 9 yr 4 mo
U-1900
9504644in 9 yr 4 mo
U-1900
9504645in 9 yr 4 mo
Product
9532944in 9 yr 4 mo
U-1900
9597284in 9 yr 4 mo
U-1900

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 Varenicline Tartrate 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.

Tyrvaya: 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 213978 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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