FDA Orange Book · active-ingredient family
Meloxicam
Meloxicam is approved as 7 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XIFYRM · NDA 218395
7
Brand (NDA)
25
Generics (ANDA)
11
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, suspension, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XIFYRMRLD | AZURITY | NDA 218395 | — | Jun 05, 2025 | |
| QAMZOVARLD | NANJING DELOVA | NDA 217593 | — | Apr 22, 2025 | |
| ANJESORLD | BAUDAX | NDA 210583 | — | Feb 20, 2020 | |
| QMIIZ ODTRLD×2 | TERSERA | NDA 211210 | — | Oct 19, 2018 | |
| VIVLODEXRLD×2 | ICEUTICA OPERATIONS | NDA 207233 | — | Oct 22, 2015 | |
| MELOXICAMRLD | AVONDALE PHARMS | NDA 021530 | — | Jun 01, 2004 | |
| MOBICRLD×2 | BOEHRINGER INGELHEIM | NDA 020938 | — | Apr 13, 2000 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MELOXICAM×2 | ASCENT PHARMS INC | ANDA 217579 | AB | Jun 07, 2023 | |
| MELOXICAM×2 | NOVITIUM PHARMA | ANDA 211398 | AB | Mar 09, 2021 | |
| MELOXICAM×2 | LUPIN | ANDA 209487 | AB | Jun 01, 2020 | |
| MELOXICAM×2 | NOVITIUM PHARMA | ANDA 077928 | AB | May 13, 2009 | |
| MELOXICAM×2 | UNICHEM | ANDA 077927 | AB | Dec 20, 2006 | |
| MELOXICAM×2 | CR DOUBLE CRANE | ANDA 078039 | — | Dec 14, 2006 | |
| MELOXICAM×2 | YUNG SHIN PHARM | ANDA 077918 | AB | Dec 07, 2006 | |
| MELOXICAM×2 | TARO | ANDA 078102 | — | Nov 07, 2006 | |
| MELOXICAM×2 | AUROBINDO PHARMA | ANDA 078008 | AB | Oct 02, 2006 | |
| MELOXICAM×2 | RISING | ANDA 077931 | AB | Jul 25, 2006 | |
| MELOXICAM×2 | COREPHARMA | ANDA 077882 | AB | Jul 20, 2006 | |
| MELOXICAM×2 | MYLAN | ANDA 077934 | — | Jul 20, 2006 | |
| MELOXICAM×2 | AIPING PHARM INC | ANDA 077920 | AB | Jul 19, 2006 | |
| MELOXICAM×2 | CHARTWELL RX | ANDA 077936 | — | Jul 19, 2006 | |
| MELOXICAM×2 | CIPLA | ANDA 077929 | AB | Jul 19, 2006 | |
| MELOXICAM×2 | GLENMARK PHARMS LTD | ANDA 077932 | AB | Jul 19, 2006 | |
| MELOXICAM×2 | IMPAX LABS INC | ANDA 077930 | — | Jul 19, 2006 | |
| MELOXICAM×2 | LUPIN PHARMS | ANDA 077944 | — | Jul 19, 2006 | |
| MELOXICAM×2 | NATCO PHARMA | ANDA 077923 | — | Jul 19, 2006 | |
| MELOXICAM×2 | PURACAP PHARM | ANDA 077938 | AB | Jul 19, 2006 | |
| MELOXICAM×2 | ROXANE | ANDA 077925 | — | Jul 19, 2006 | |
| MELOXICAM×2 | SUN PHARM INDS INC | ANDA 077937 | — | Jul 19, 2006 | |
| MELOXICAM×2 | TP ANDA HOLDINGS | ANDA 077935 | — | Jul 19, 2006 | |
| MELOXICAM×2 | YABAO PHARM | ANDA 077933 | — | Jul 19, 2006 | |
| MELOXICAM×2 | ZYDUS PHARMS USA | ANDA 077921 | AB | Jul 19, 2006 |
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10709713 | May 26, 2030 | in 4 yr | U-2750 |
| 11253478 | May 26, 2030 | in 4 yr | ProductU-3318 |
| 9974746 | May 26, 2030 | in 4 yr | Product |
| 8545879 | Aug 31, 2030 | in 4 yr 3 mo | Product |
| 9526734 | Mar 31, 2033 | in 6 yr 11 mo | Product |
| 9808468 | Mar 31, 2035 | in 8 yr 11 mo | U-2165 |
| 9649318 | Mar 31, 2035 | in 8 yr 11 mo | Product |
| 11458145 | Mar 08, 2039 | in 12 yr 11 mo | U-3318 |
| 10881663 | Mar 08, 2039 | in 12 yr 11 mo | U-3038 |
| 12059423 | Jul 19, 2040 | in 14 yr 3 mo | SubstanceProduct |
| 12263176 | Jul 31, 2041 | in 15 yr 4 mo | Product |
Meloxicam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
