FDA Orange Book
Generic for Qvar Redihaler
Qvar Redihaler contains beclomethasone dipropionate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Qvar Redihaler is beclomethasone dipropionate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Qvar Redihaler products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.04MG/INH | Marketed (Rx) | None | 2 | AB |
| aerosol, metered, inhalation | 0.08MG/INH | Marketed (Rx) | None | 2 | AB |
NDA 207921, held by NORTON WATERFORD LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic beclomethasone dipropionate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL IRELAND LTD | 213811 | AB (A-rated, therapeutically equivalent) | December 16, 2025 | 0.04MG/INH, 0.08MG/INH |
| AUROLIFE PHARMA LLC | 214418 | AB (A-rated, therapeutically equivalent) | September 14, 2026 | 0.04MG/INH, 0.08MG/INH |
Qvar Redihaler patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8132712 | September 7, 2028 | Drug product | None | 207921 |
| 11395889 | May 18, 2031 | Drug product | None | 207921 |
| 10022510 | May 18, 2031 | Drug product | None | 207921 |
| 10695512 | May 18, 2031 | Drug product | None | 207921 |
| 10022509 | May 18, 2031 | Drug product | None | 207921 |
| 10086156 | May 18, 2031 | Drug product | None | 207921 |
| 8931476 | July 17, 2031 | Drug product | None | 207921 |
| 10561808 | January 1, 2032 | Drug product | None | 207921 |
| 12296089 | January 26, 2038 | Drug product | None | 207921 |
| 11793953 | January 26, 2038 | Drug product | None | 207921 |
| 11395888 | January 26, 2038 | Drug product | None | 207921 |
| 11865247 | January 26, 2038 | Drug product | None | 207921 |
| 11896759 | January 26, 2038 | Drug product | None | 207921 |
| 10792447 | January 25, 2039 | Drug product | None | 207921 |
| 11559637 | July 21, 2039 | Drug product | None | 207921 |
| 11957832 | May 5, 2041 | Drug product | None | 207921 |
| 11583643 | August 19, 2041 | Drug product | None | 207921 |
Qvar Redihaler NDC codes
Questions
Is there a generic for Qvar Redihaler?
Yes. The generic name for Qvar Redihaler is beclomethasone dipropionate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Qvar Redihaler?
The active ingredient in Qvar Redihaler is beclomethasone dipropionate, per the FDA Orange Book.
When does the Qvar Redihaler patent expire?
The last patent listed for Qvar Redihaler in the Orange Book expires August 19, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Qvar Redihaler and Beclomethasone Dipropionate
- What is Qvar Redihaler used for?FDA label uses
- Is Qvar Redihaler a controlled substance?Federal schedule
- Generic for QvarFDA Orange Book
- Generic for QnaslFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 50090-3458Qvar Redihaler NDC record
- NDC 50090-3459Qvar Redihaler NDC record
- NDC 50090-5031Qvar Redihaler NDC record