Viewing data from:

SINUVA

NDA

MOMETASONE FUROATE | N209310 | INTERSECT ENT INC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Expired (1)Expiring < 1yr (2)Active (4)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Nov. 29, 2026

Jun. 12, 2027

Feb. 8, 2032

Apr. 4, 2026

Nov. 24, 2034

Oct. 3, 2031

Mar. 13, 2034

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Sinuva (2023)

Total Spending

$320K

Total Claims

182

Beneficiaries

166

ASP Price

—

HCPCS: J7402 — Mometasone furoate sinus implant, (sinuva), 10 micrograms

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain33 active DMFs3 inactive

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

TAPI NL BVMOMETASONE FUROATE USP

DMF 150632000

WAVELENGTH ENTERPRISES LTDMOMETASONE FUROATE

DMF 151872000

STERLING SPAMOMETASONE FUROATE

DMF 166482003

SYMBIOTEC PHARMALAB PRIVATE LTDMOMETASONE FUROATE USP (MICRONISED)

DMF 206842007

AURISCO PHARMACEUTICAL CO LTDMOMETASONE FUROATE USP, NON-STERILE BULK

DMF 211412007

AARTI PHARMALABS LTDMOMETASONE FUROATE

DMF 213342008

HALCYON LABS PRIVATE LTDMOMETASONE FUROATE USP

DMF 216542008

NEWCHEM SPAMOMETASONE FUROATE MICRONIZED

DMF 219932008

FARMABIOS SPAMOMETASONE FUROATE

DMF 223192008

TARO PHARMACEUTICAL INDUSTRIES LTDMOMETASONE FUROATE USP/PH EUR MICRONIZED

DMF 235022010

WAVELENGTH ENTERPRISES LTDMOMETASONE FUROATE MONOHYDRATE

DMF 238882010

CURIA SPAIN SAUMOMETASONE FUROATE MICRONIZED

DMF 239162010

AARTI PHARMALABS LTDMOMETASONE FUROATE MONOHYDRATE

DMF 239772010

SYMBIOTEC PHARMALAB PRIVATE LTDMOMETASONE FUROATE MONOHYDRATE

DMF 254482011

HOVIONE FARMACIENCIA SAMOMETASONE FUROATE MONOHYDRATE INHALATION GRADE

DMF 259872012

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDMOMETASONE FUROATE

DMF 261532012

STERLING SPAMOMETASONE FUROATE MONOHYDRATE (D90<10UM)

DMF 270222013

CIPLA LTDMOMETASONE FUROATE MONOHYDRATE

DMF 272442013

AARTI PHARMALABS LTDMOMETASONE FUROATE MONOHYDRATE

DMF 279562014

CORAL DRUGS PRIVATE LTDMOMETASONE FUROATE

DMF 308522016

CORAL DRUGS PRIVATE LTDMOMETASONE FUROATE MONOHYDRATE

DMF 310762016

TIANJIN TIANYAO PHARMACEUTICALS CO LTDMOMETASONE FUROATE USP BULK API

DMF 313622017

AARTI PHARMALABS LTDMOMETASONE FUROATE USP (ALTERNATE PROCESS)

DMF 331742018

FARMABIOS SPAMOMETASONE FUROATE (ALTERNATE PROCESS)

DMF 334462019

TIANJIN TIANYAO PHARMACEUTICALS CO LTDMOMETASONE FUROATE MONOHYDRATE BULK API

DMF 341122019

INDUSTRIALE CHIMICA SRLMOMETASONE FUROATE

DMF 350092020

CORAL DRUGS PVT LTDMOMETASONE FUROATE USP (PROCESS I)

DMF 356862021

HENAN LIHUA PHARMACEUTICAL CO LTDMOMETASONE FUROATE

DMF 361822021

BREATHGREEN PHARMACEUTICAL CO LTDMOMETASONE FUROATE (MICRONIZED AND NON-MICRONIZED)

DMF 393022023

BREATHGREEN PHARMACEUTICAL CO LTDMOMETASONE FUROATE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)

DMF 393032023

HENAN LIHUA PHARMACEUTICAL CO LTDMOMETASONE FUROATE PRECESS B

DMF 404072024

CIPLA LTDMOMETASONE FUROATE USP

DMF 413552025

NEWCHEM SPAMOMETASONE FUROATE MONOHYDRATE MICRONISED

DMF 423442025

SYMBIOTEC PHARMALAB PRIVATE LTDInactiveMOMETASONE FUROATE

DMF 197812006

CIPLA LTDInactiveMOMETASONE FUROATE MONOHYDRATE

DMF 209692007

HUNAN YUXIN PHARMACEUTICAL CO LTDInactiveMOMETASONE FUROATE

DMF 259582012

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 23, 2023	SUPPL -6	View Letter (PDF)
Jan 17, 2018	SUPPL -1	View Letter (PDF)
Dec 11, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.35MG

RLD

7 patents0 exclusivities▴

IMPLANT;IMPLANTATION | Approved: Dec 8, 2017

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7544192	Nov 29, 2026	—	—	—		—
8025635	Jun 12, 2027	—	—	Yes		—
8763222	Feb 8, 2032	—	—	Yes	—	—
9585681	Apr 4, 2026	—	—	—		—
10232152	Nov 24, 2034	—	—	Yes		—
10357640	Oct 3, 2031	—	—	—		—
10406332	Mar 13, 2034	—	—	Yes	—	—