FDA Orange Book · active-ingredient family
Oxybutynin chloride
Oxybutynin chloride is approved as 4 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GELNIQUE · NDA 022204
4
Brand (NDA)
34
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · gel, syrup, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GELNIQUERLD | ABBVIE | NDA 022204 | — | Jan 27, 2009 | |
| DITROPAN XLRLD×3 | JANSSEN PHARMS | NDA 020897 | — | Dec 16, 1998 | |
| DITROPANRLD | ORTHO MCNEIL JANSSEN | NDA 018211 | — | Approved Prior to Jan 1, 1982 | |
| DITROPANRLD | JANSSEN PHARMS | NDA 017577 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (34)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXYBUTYNIN CHLORIDE×2 | STRIDES PHARMA INTL | ANDA 075079 | AB | Mar 10, 2026 | |
| OXYBUTYNIN CHLORIDE×2 | RISING | ANDA 209025 | AB | Feb 07, 2023 | |
| OXYBUTYNIN CHLORIDE | REGCON HOLDINGS | ANDA 213550 | AB | Jul 14, 2022 | |
| OXYBUTYNIN CHLORIDE | STRIDES PHARMA | ANDA 208165 | AB | Dec 17, 2020 | |
| OXYBUTYNIN CHLORIDE×3 | RUBICON RESEARCH | ANDA 214415 | AB | Oct 27, 2020 | |
| OXYBUTYNIN CHLORIDE | LEADING | ANDA 212798 | AB | Apr 06, 2020 | |
| OXYBUTYNIN CHLORIDE×3 | BIONPHARMA | ANDA 210717 | AB | Dec 17, 2019 | |
| OXYBUTYNIN CHLORIDE | NOVAST LABS | ANDA 210611 | AB | Oct 30, 2019 | |
| OXYBUTYNIN CHLORIDE | AVET LIFESCIENCES | ANDA 211682 | AB | May 10, 2019 | |
| OXYBUTYNIN CHLORIDE×3 | AJANTA PHARMA LTD | ANDA 211655 | AB | Feb 28, 2019 | |
| OXYBUTYNIN CHLORIDE | HIBROW HLTHCARE | ANDA 211062 | — | Feb 06, 2019 | |
| OXYBUTYNIN CHLORIDE | TP ANDA HOLDINGS | ANDA 210125 | AB | Sep 06, 2018 | |
| OXYBUTYNIN CHLORIDE | CHARTWELL RX | ANDA 207329 | — | May 31, 2018 | |
| OXYBUTYNIN CHLORIDE | ABHAI LLC | ANDA 209335 | AB | Dec 22, 2017 | |
| OXYBUTYNIN CHLORIDE | NOVITIUM PHARMA | ANDA 209823 | AB | Oct 23, 2017 | |
| OXYBUTYNIN CHLORIDE×3 | ZYDUS PHARMS | ANDA 202332 | AB | Jun 26, 2017 | |
| OXYBUTYNIN CHLORIDE×3 | UNIQUE | ANDA 206121 | AB | May 27, 2016 | |
| OXYBUTYNIN CHLORIDE×3 | ACCORD HLTHCARE | ANDA 207138 | AB | Feb 29, 2016 | |
| OXYBUTYNIN CHLORIDE×3 | AMNEAL PHARMS | ANDA 204010 | AB | Nov 23, 2015 | |
| OXYBUTYNIN CHLORIDE×3 | OSMOTICA PHARM US | ANDA 078503 | AB | Feb 04, 2009 | |
| OXYBUTYNIN CHLORIDE×3 | IMPAX PHARMS | ANDA 076745 | — | May 09, 2007 | |
| OXYBUTYNIN CHLORIDE | PHARMOBEDIENT | ANDA 076702 | — | Nov 09, 2006 | |
| OXYBUTYNIN CHLORIDE×2 | PHARMOBEDIENT | ANDA 076644 | — | Nov 09, 2006 | |
| OXYBUTYNIN CHLORIDE | LANNETT CO INC | ANDA 076682 | — | Dec 28, 2004 | |
| OXYBUTYNIN CHLORIDE | CHARTWELL RX | ANDA 075039 | AA | Jan 29, 1999 | |
| OXYBUTYNIN CHLORIDE | PHARM ASSOC | ANDA 075137 | — | Dec 18, 1998 | |
| OXYBUTYNIN CHLORIDE | PHARM ASSOC | ANDA 074997 | — | Oct 15, 1997 | |
| OXYBUTYNIN CHLORIDE | PHARMOBEDIENT CNSLTG | ANDA 074868 | — | Feb 12, 1997 | |
| OXYBUTYNIN CHLORIDE | AIPING PHARM INC | ANDA 074625 | AB | Jul 31, 1996 | |
| OXYBUTYNIN CHLORIDE | LANNETT CO INC | ANDA 074520 | AA | Mar 29, 1996 | |
| OXYBUTYNIN CHLORIDE | WATSON LABS | ANDA 072485 | — | Apr 19, 1989 | |
| OXYBUTYNIN CHLORIDE | QUANTUM PHARMICS | ANDA 072296 | — | Dec 08, 1988 | |
| OXYBUTYNIN CHLORIDE | TEVA PHARMS USA | ANDA 071655 | AB | Nov 14, 1988 | |
| OXYBUTYNIN CHLORIDE | USL PHARMA | ANDA 070746 | — | Mar 10, 1988 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10449173 | Nov 06, 2029 | in 3 yr 5 mo | ProductU-2637 |
| 9259388 | Nov 06, 2029 | in 3 yr 5 mo | U-1644 |
| 8920392 | Mar 26, 2031 | in 4 yr 10 mo | U-1644 |
Oxybutynin chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
