Viewing data from:

NUMBRINO

NDA

COCAINE HYDROCHLORIDE | N209575 | OMNIVIUM PHARMACEUTICALS LLC

1 strength11 unique patents0 unique exclusivities

Patent Timeline

11 unique patents by expiration date

Active (11)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

Today

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

Feb. 7, 2037

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Genus Lifesciences Inc. v. Lannett Company, Inc. 1:2020cv00770 3 patentscocaine hydrochloride	D. Del.	2020-06-08	Terminated 2021-10-20	—

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
Contingency Management Plus Deep Transcranial Magnetic Stimulation for the Treatment of Cocaine Use Disorder NCT07490600	N/A	Recruiting	The University of Texas Health Science Center, Houston	100	2026-04-21 → 2029-09-01

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

NATIONAL INSTITUTES HEALTH NATIONAL INSTITUTE DRUG ABUSECOCAINE HYDROCHLORIDE INJECTABLES

DMF 165792003

SPECGX LLCCOCAINE HYDROCHLORIDE USP

DMF 209952007

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 28, 2020	SUPPL -2	View Letter (PDF)
Jan 14, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4%

RLD

11 patents0 exclusivities▴

SOLUTION;NASAL | Approved: Jan 10, 2020

Patents (11)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9867815	Feb 7, 2037	—	—	—		—
10016407	Feb 7, 2037	—	—	—		—
10149843	Feb 7, 2037	—	—	—		—
10231961	Feb 7, 2037	—	—	Yes	—	—
10413505	Feb 7, 2037	—	—	—		—
10420760	Feb 7, 2037	—	—	—		—
10857095	Feb 7, 2037	—	—	—		—
10894012	Feb 7, 2037	—	—	—		—
10933060	Feb 7, 2037	—	—	—		—
10973811	Feb 7, 2037	—	—	—		—
11040032	Feb 7, 2037	—	—	Yes	—	—