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Orange Book drug · Brand (NDA)

Qvar Redihaler

Beclomethasone Dipropionate

RLDNDA 207921 2 strengths Norton Waterford
Approved
Aug 03, 2017
Strengths
2
Listed patents
17

What does the FDA Orange Book show for Qvar Redihaler?

Qvar Redihaler contains Beclomethasone Dipropionate and is the new drug FDA Orange Book record for NDA 207921. The application has 2 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 207921

New drug application identity from the Orange Book snapshot.

Application holder
Norton Waterford Ltd

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

Product presentations
2

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
17

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
0010.04MG/INHAEROSOL, METEREDINHALATIONPrescriptionNone posted
RLDRS
0020.08MG/INHAEROSOL, METEREDINHALATIONPrescriptionNone 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

Norton Waterford Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 207921.

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

2 presentations 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

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

The latest future date recorded across those files is Aug 19, 2041. 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 7 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 207921 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-207921

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

2 approved presentations · NDA 207921
RLDRS
Strength
0.04MG/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    9 yr 1 mo ago

  2. Today

  3. Patent 8132712 expires

    Listed drug product patent expiration.

    in 2 yr 2 mo

  4. Patent 10022509 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  5. Patent 10022510 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  6. Patent 10086156 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  7. Patent 10695512 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  8. Patent 11395889 expires

    Listed drug product patent expiration.

    in 4 yr 11 mo

  9. Patent 8931476 expires

    Listed drug product patent expiration.

    in 5 yr 1 mo

  10. Patent 10561808 expires

    Listed drug product patent expiration.

    in 5 yr 6 mo

  11. Patent 11395888 expires

    Listed drug product patent expiration.

    in 11 yr 8 mo

  12. Patent 11793953 expires

    Listed drug product patent expiration.

    in 11 yr 8 mo

  13. Patent 12296089 expires

    Listed drug product patent expiration.

    in 11 yr 8 mo

  14. Patent 10792447 expires

    Listed drug product patent expiration.

    in 12 yr 8 mo

  15. Patent 11559637 expires

    Listed drug product patent expiration.

    in 13 yr 2 mo

  16. Patent 11957832 expires

    Listed drug product patent expiration.

    in 15 yr

  17. Patent 11583643 expires

    Listed drug product patent expiration.

    in 15 yr 3 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayPatent 8132712: 2028-09-07Patent 8132712Patent 10022509: 2031-05-18Patent 10022509Patent 10022510: 2031-05-18Patent 10022510Patent 10086156: 2031-05-18Patent 10086156Patent 10695512: 2031-05-18Patent 10695512Patent 11395889: 2031-05-18Patent 11395889Patent 8931476: 2031-07-17Patent 8931476Patent 10561808: 2032-01-01Patent 10561808Patent 11395888: 2038-01-26Patent 11395888Patent 11793953: 2038-01-26Patent 11793953Patent 12296089: 2038-01-26Patent 12296089Patent 10792447: 2039-01-25Patent 10792447Patent 11559637: 2039-07-21Patent 11559637Patent 11957832: 2041-05-05Patent 11957832Patent 11583643: 2041-08-19Patent 11583643
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BECLOMETHASONE DIPROPIONATE

Strength

0.04MG/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 207921

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
8132712in 2 yr 2 mo
ProductDelisted
10022509in 4 yr 11 mo
ProductDelisted
10022510in 4 yr 11 mo
ProductDelisted
10086156in 4 yr 11 mo
ProductDelisted
10695512in 4 yr 11 mo
ProductDelisted
11395889in 4 yr 11 mo
ProductDelisted
8931476in 5 yr 1 mo
Product
10561808in 5 yr 6 mo
ProductDelisted
11395888in 11 yr 8 mo
Product
11793953in 11 yr 8 mo
Product
12296089in 11 yr 8 mo
Product
10792447in 12 yr 8 mo
Product
11559637in 13 yr 2 mo
Product
11957832in 15 yr
Product
11583643in 15 yr 3 mo
Product

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 Beclomethasone Dipropionate 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.

Qvar Redihaler: 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 207921 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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