FDA Orange Book · active-ingredient family
Beclomethasone dipropionate
Beclomethasone dipropionate is approved as 8 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:QVAR REDIHALER · NDA 207921
8
Brand (NDA)
1
Generics (ANDA)
20
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QVAR REDIHALERRLD×2 | NORTON WATERFORD | NDA 207921 | — | Aug 03, 2017 | |
| QNASLRLD×2 | TEVA BRANDED PHARM | NDA 202813 | — | Dec 17, 2014 | |
| QVAR 40RLD×2 | TEVA BRANDED PHARM | NDA 020911 | — | Sep 15, 2000 | |
| VANCERIL DOUBLE STRENGTH | SCHERING | NDA 020486 | — | Dec 24, 1996 | |
| BECLOVENT | GLAXOSMITHKLINE | NDA 018153 | — | Approved Prior to Jan 1, 1982 | |
| VANCERIL | SCHERING | NDA 017573 | — | Approved Prior to Jan 1, 1982 | |
| BECONASE | GLAXOSMITHKLINE | NDA 018584 | — | Approved Prior to Jan 1, 1982 | |
| VANCENASE | SCHERING | NDA 018521 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BECLOMETHASONE DIPROPIONATE×2 | AMNEAL IRELAND LTD | ANDA 213811 | — | Dec 16, 2025 |
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8132712 | Sep 07, 2028 | in 2 yr 3 mo | ProductDelisted |
| 10022510 | May 18, 2031 | in 5 yr | ProductDelisted |
| 10086156 | May 18, 2031 | in 5 yr | ProductDelisted |
| 9808587 | May 18, 2031 | in 5 yr | ProductDelisted |
| 9463289 | May 18, 2031 | in 5 yr | ProductDelisted |
| 10022509 | May 18, 2031 | in 5 yr | ProductDelisted |
| 11395889 | May 18, 2031 | in 5 yr | ProductDelisted |
| 10695512 | May 18, 2031 | in 5 yr | ProductDelisted |
| 8931476 | Jul 17, 2031 | in 5 yr 2 mo | Product |
| 10188811 | Oct 21, 2031 | in 5 yr 5 mo | Product |
| 10561808 | Jan 01, 2032 | in 5 yr 7 mo | ProductDelisted |
| 12296089 | Jan 26, 2038 | in 11 yr 9 mo | Product |
| 11793953 | Jan 26, 2038 | in 11 yr 9 mo | Product |
| 11395888 | Jan 26, 2038 | in 11 yr 9 mo | Product |
| 11865247 | Jan 26, 2038 | in 11 yr 9 mo | ProductDelisted |
| 11896759 | Jan 26, 2038 | in 11 yr 9 mo | ProductDelisted |
| 10792447 | Jan 25, 2039 | in 12 yr 9 mo | Product |
| 11559637 | Jul 21, 2039 | in 13 yr 3 mo | Product |
| 11957832 | May 05, 2041 | in 15 yr 1 mo | Product |
| 11583643 | Aug 19, 2041 | in 15 yr 5 mo | Product |
Beclomethasone dipropionate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
