Viewing data from:

RYALTRIS

NDA

MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE | N211746 | GLENMARK SPECIALTY SA

1 strength16 unique patents0 unique exclusivities

Patent Timeline

16 unique patents by expiration date

Active (16)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 4, 2034

Sep. 3, 2038

Sep. 4, 2034

Apr. 8, 2039

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 D Spending

CMS annual spending data for Ryaltris (2023)

Total Spending

$1.0M

Total Claims

3,469

Beneficiaries

1,894

Avg Cost/Unit

$8.83

Spending Trend

$15K(2022)→$1.0M(2023)

YoY Change:-2.9%

5yr CAGR:-2.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2023	SUPPL -4	View Letter (PDF)
Jun 26, 2023	SUPPL -3	View Letter (PDF)
Oct 3, 2022	SUPPL -2	View Letter (PDF)
Jan 18, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.025MG/SPRAY;0.665MG/SPRAY

RLD

16 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Jan 13, 2022

Patents (16)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9078923	Sep 4, 2034	—	—	Yes		—
9370483	Sep 4, 2034	—	—	Yes	—	—
9750754	Sep 4, 2034	—	—	Yes		—
9937189	Sep 4, 2034	—	—	Yes	—	—
10016443	Sep 4, 2034	—	—	—		—
10376526	Sep 4, 2034	—	—	Yes	—	—
10517880	Sep 4, 2034	—	—	Yes		—
10548907	Sep 4, 2034	—	—	—		—
10561672	Sep 4, 2034	—	—	Yes	—	—
10646500	Sep 4, 2034	—	—	—		—
10758550	Sep 4, 2034	—	—	—		—
10765686	Sep 4, 2034	—	—	—		—
11400101	Sep 4, 2034	—	—	—		—
11679210	Sep 3, 2038	—	—	Yes	—	—
12064442	Sep 4, 2034	—	—	—		—
12303635	Apr 8, 2039	—	Yes	Yes	—	—