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SKYCLARYS

NDA

OMAVELOXOLONE | N216718 | BIOGEN US CORPORATION

1 strength7 unique patents3 unique exclusivities

Patent Timeline

7 unique patents, 3 exclusivities by expiration date

Active (7)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

Dec. 3, 2029

Apr. 20, 2029

Apr. 24, 2033

Apr. 20, 2029

Apr. 24, 2033

Apr. 20, 2029

Apr. 20, 2029

M-270

Dec. 20, 2027

NCE

Feb. 28, 2028

ODE-427

Feb. 28, 2030

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 Skyclarys (2023)

Total Spending

$45.0M

Total Claims

1,428

Beneficiaries

321

Avg Cost/Unit

$357.57

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 9, 2026	SUPPL -14	View Letter (PDF)
Dec 26, 2024	SUPPL -8	View Letter (PDF)
Dec 26, 2024	SUPPL -9	View Letter (PDF)
Jan 26, 2024	SUPPL -2	View Letter (PDF)
Mar 1, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

RLD

7 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Feb 28, 2023

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8124799	Dec 3, 2029	—	Yes	—	—	—
8440854	Apr 20, 2029	—	—	Yes	—	—
8993640	Apr 24, 2033	—	Yes	Yes	—	—
9670147	Apr 20, 2029	—	Yes	—	—	—
9701709	Apr 24, 2033	—	Yes	Yes	—	—
11091430	Apr 20, 2029	—	—	—		—
11919838	Apr 20, 2029	—	—	—		—

Exclusivities (3)

Code	Date	Status
M-270	Dec 20, 2027	Active
NCE	Feb 28, 2028	Active
ODE-427	Feb 28, 2030	Active