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NDA

MELOXICAM | N207233 | ICEUTICA OPERATIONS LLC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

9526734

Mar. 31, 2033

9649318

Mar. 31, 2035

9808468

Mar. 31, 2035

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
iCeutica Pty Ltd. et al v. Novitium Pharma LLC 1:2018cv00599 3 patentsANDA 211398Meloxicam	D. Del.	2018-04-20	Terminated 2020-01-22	—
iCeutica Pty Ltd. et al v. Apotex, Inc. et al 1:2017cv01554 2 patentsANDA 210298Meloxicam	D. Del.	2017-10-31	Terminated 2018-06-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain14 active DMFs9 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

BIDACHEM SPAMELOXICAM

DMF 138461998

ARCH PHARMALABS LTDMELOXICAM USP

DMF 159262002

UNICHEM LABORATORIES LTDMELOXICAM USP

DMF 161892002

CIPLA LTDMELOXICAM USP

DMF 171482004

ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPAMELOXICAM

DMF 172382004

ZYDUS LIFESCIENCES LTDMELOXICAM USP

DMF 173582004

UNIMARK REMEDIES LTDMELOXICAM USP

DMF 182862005

SWATI SPENTOSE PRIVATE LTDMELOXICAM

DMF 188372005

APITORIA PHARMA PRIVATE LTDMELOXICAM USP

DMF 189212005

QUIMICA SINTETICA SAMELOXICAM

DMF 189842005

DERIVADOS QUIMICOS SAUMELOXICAM

DMF 242052010

SHANDONG XINHUA PHARMACEUTICAL CO LTDMELOXICAM

DMF 244762010

IPCA LABORATORIES LTDMELOXICAM USP

DMF 375672022

APEX HEALTHCARE LTDMELOXICAM USP

DMF 399112024

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveMELOXICAM JETMILLED

DMF 144301999

ESTEVE QUIMICA SAInactiveMELOXICAM

DMF 166862003

DR REDDYS LABORATORIES LTDInactiveMELOXICAM

DMF 173662004

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMELOXICAM

DMF 182552005

ALKERMES INCInactiveMELOXICAM NANOCRYSTAL® TABLETS

DMF 188052005

CADILA PHARMACEUTICALS LTDInactiveMELOXICAM

DMF 192162006

SICHUAN SANCHINE SUNNYHOPE PHARMACEUTICAL CO LTDInactiveMELOXICAM USP (DRUG SUBSTANCE, NON-STERILE)

DMF 219482008

IROKO PHARMACEUTICALS LLCInactiveMELOXICAM SOLUMATRIX® CAPSULES

DMF 255082011

MICRO LABS LTD INDIAInactiveMELOXICAM USP

DMF 257852012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -5	View Letter (PDF)
Apr 30, 2021	SUPPL -4	View Letter (PDF)
Oct 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

3 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 22, 2015

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9526734	Mar 31, 2033	—	—	Yes	—	—
9649318	Mar 31, 2035	—	—	Yes	—	—
9808468	Mar 31, 2035	—	—	—		—

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

3 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 22, 2015