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VALTOCO

NDA

DIAZEPAM | N211635 | NEURELIS INC

3 strengths8 unique patents2 unique exclusivities

Patent Timeline

8 unique patents, 2 exclusivities by expiration date

Active (8)TodayExclusivityIPRPTAB Challenge

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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2039

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2043

Today

Mar. 27, 2029IPR

Mar. 27, 2029IPR

Mar. 27, 2029IPR

Mar. 27, 2029

Oct. 16, 2032

Jun. 13, 2032

Mar. 27, 2029

Jun. 10, 2042

ODE-279

Jan. 10, 2027

NPP

Apr. 15, 2028

PTAB Proceedings

3 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2025-00464	8895546	IPR	Padagis US LLC et al.	Trial Instituted	2025-01-17	2025-09-16
IPR2025-00465	11241414	IPR	Padagis US LLC et al.	Trial Instituted	2025-01-17	2025-09-16
IPR2025-00466	11793786	IPR	Padagis US LLC et al.	Trial Instituted	2025-01-17	2025-09-16

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

5 cases on OB patents (5 active) from PACER

Case	Court	Filed	Status	Judge
Neurelis, Inc. v. Lupin Inc. et al 1:2026cv00258 1 patentANDA 220394diazepam	D. Del.	2026-03-11	Active	—
Neurelis, Inc. v. Amneal Pharmaceuticals LLC et al 1:2026cv00261 6 patentsANDA 219109diazepam	D. Del.	2026-03-11	Active	—
Neurelis, Inc. v. Lupin Inc. et al 1:2025cv01443 2 patentsANDA 220394diazepam nasal spray	D. Del.	2025-11-26	Active	—
Neurelis, Inc. v. Padagis LLC et al 1:2025cv01228 2 patentsANDA 219320diazepam	D. Del.	2025-10-03	Active	—
Neurelis, Inc. v. Padagis LLC et al 1:2025cv00821 4 patentsANDA 219320, 220394diazepam	D. Del.	2025-07-02	Active	—

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

Medicare Part D Spending

CMS annual spending data for Valtoco (2023)

Total Spending

$17.2M

Total Claims

15,115

Beneficiaries

6,956

Avg Cost/Unit

$351.94

Spending Trend

$1.3M(2020)→$5.6M(2021)→$10.4M(2022)→$17.2M(2023)

YoY Change:+6.9%

5yr CAGR:+7.0%

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

API Supply Chain5 active DMFs3 inactive

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

CAMBREX PROFARMACO MILANO SRLDIAZEPAM

DMF 14781970

FIS FABBRICA ITALIANA SINTETICI SPADIAZEPAM

DMF 31641978

CENTAUR PHARMACEUTICALS PRIVATE LTDDIAZEPAM USP

DMF 218602008

R L FINE CHEM PVT LTDDIAZEPAM

DMF 338582019

NAVINTA LLCDIAZEPAM USP

DMF 388442023

DELMAR CHEMICALS INCInactiveDIAZEPAM USP BULK

DMF 25821976

GEDEON RICHTER LTDInactiveDIAZEPAM USP

DMF 60711985

FDC PRIVATE LTDInactiveDIAZEPAM U.S.P. XXI

DMF 70251987

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 27, 2025	SUPPL -12	View Letter (PDF)
Apr 21, 2025	SUPPL -10	View Letter (PDF)
Jan 17, 2023	SUPPL -8	View Letter (PDF)
Feb 8, 2022	SUPPL -7	View Letter (PDF)
Feb 9, 2021	SUPPL -3	View Letter (PDF)
Jan 14, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG/SPRAY

RLD

8 patents2 exclusivities▴

SPRAY;NASAL | Approved: Jan 10, 2020

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8895546	Mar 27, 2029	—	—	Yes	—	—
11241414	Mar 27, 2029	—	—	Yes	—	—
11793786	Mar 27, 2029	—	—	Yes	—	—
12268664	Mar 27, 2029	—	—	Yes	—	—
12324852	Oct 16, 2032	—	—	—		—
12337061	Jun 13, 2032	—	—	—		—
12521400	Mar 27, 2029	—	—	Yes	—	—
12599611	Jun 10, 2042	—	—	—	U-4455	—

Exclusivities (2)

Code	Date	Status
NPP	Apr 15, 2028	Active
ODE-279	Jan 10, 2027	< 1 year

#002 — 7.5MG/SPRAY

RLD

8 patents2 exclusivities▾

SPRAY;NASAL | Approved: Jan 10, 2020

#003 — 10MG/SPRAY

RLD

8 patents2 exclusivities▾

SPRAY;NASAL | Approved: Jan 10, 2020