Viewing data from:

VUMERITY

NDA

DIROXIMEL FUMARATE | N211855 | BIOGEN INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

8669281

Oct. 29, 2033

9090558

Sep. 20, 2033

10080733

Sep. 20, 2033

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
Biogen Inc. et al v. Zydus Worldwide DMCC et al 1:2023cv00732 3 patentsANDA 218596diroximel fumarate	D. Del.	2023-07-06	Terminated 2025-08-13	—
Biogen Inc. et al v. Teva Pharmaceuticals Development Inc. 1:2021cv00389 3 patentsANDA 214206diroximel fumarate	D. Del.	2021-03-17	Terminated 2021-10-08	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease NCT06319339	Early Phase 1	Recruiting	University of Nebraska	20	2024-11-14 → 2026-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Vumerity (2023)

Total Spending

$152.4M

Total Claims

16,568

Beneficiaries

2,304

Avg Cost/Unit

$73.35

Spending Trend

$108K(2019)→$17.0M(2020)→$99.9M(2021)→$119.6M(2022)→$152.4M(2023)

YoY Change:+6.5%

5yr CAGR:+5.1%

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

API Supply Chain7 active DMFs

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

STERLING PHARMA SOLUTIONS LTDDIROXIMEL FUMARATE DRUG SUBSTANCE

DMF 329772018

TAPI NL BVDIROXIMEL FUMARATE

DMF 337522019

INTAS PHARMACEUTICALS LTDDIROXIMEL FUMARATE

DMF 346772020

ZYDUS LIFESCIENCES LTDDIROXIMEL FUMARATE

DMF 353732020

ALIVUS LIFE SCIENCES LTDDIROXIMEL FUMARATE

DMF 357852021

DR REDDYS LABORATORIES LTDDIROXIMEL FUMARATE

DMF 357932021

HONOUR LAB LTDDIROXIMEL FUMARATE

DMF 360192021

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Sep 16, 2024	SUPPL -17	View Letter (PDF)
Mar 25, 2024	SUPPL -15	View Letter (PDF)
Dec 14, 2023	SUPPL -16	View Letter (PDF)
Feb 13, 2023	SUPPL -9	View Letter (PDF)
Jan 17, 2023	SUPPL -11	View Letter (PDF)
Oct 3, 2022	SUPPL -10	View Letter (PDF)
Sep 30, 2022	SUPPL -10	View Letter (PDF)
Feb 14, 2022	SUPPL -6	View Letter (PDF)
Feb 1, 2021	SUPPL -4	View Letter (PDF)
Aug 25, 2020	SUPPL -2	View Letter (PDF)
Nov 1, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 231MG

RLDAB

3 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Oct 29, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8669281	Oct 29, 2033	—	Yes	Yes	—	—
9090558	Sep 20, 2033	—	—	—		—
10080733	Sep 20, 2033	—	Yes	Yes		—

Change History (1)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Biogen Inc. updated its corporate name to Biogen for VUMERITY (diroximel fumarate), NDA 211855.

Old: BIOGEN INC

New: BIOGEN