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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

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Feb. 7, 2037

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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

23 trials from ClinicalTrials.gov — 1 recruiting, 16 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution NCT04792034	Phase 3	Recruiting	LXO Ireland	40	2025-12-06 → 2027-12-31
Topical Application of Cocaine HCl 4%, or 10%, or Placebo Solution in Local (Topical) Anesthesia NCT02500836	Phase 3	Completed	Lannett Company, Inc.	646	2015-09 → 2016-07
GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration NCT02302976	Phase 1	Completed	Yale University	13	2014-11 → 2018-08-01
Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1 NCT00067535	Phase 1	Completed	National Institute on Drug Abuse (NIDA)	16	2003-06 → 2005-06
Therapeutic Cocaine Vaccine: Human Laboratory Study NCT00965263	Phase 2	Completed	New York State Psychiatric Institute	15	2003-03 → 2009-08
Phendimetrazine and Cocaine NCT02233647	Early Phase 1	Completed	William Stoops	11	2014-09 → 2015-12
Acute Withdrawal From Smoked Cocaine - 9 NCT00000292	Phase 1	Completed	National Institute on Drug Abuse (NIDA)	—	1996-04 → 2001-12
Human Dopamine Transported Imaging in Cocaine Abuse: 1 - 1 NCT00000315	Phase 1	Completed	National Institute on Drug Abuse (NIDA)	—	1996-11 → 2001-12
Stress Hormones and Human Cocaine Use - 7 NCT00000290	Phase 1	Completed	National Institute on Drug Abuse (NIDA)	—	1997-05 → 2001-12
Investigation of Cocaine Addiction Using mGluR5 PET and fMRI NCT03471182	Phase 1	Completed	Yale University	32	2018-02-26 → 2022-08-18

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

API Supply Chain2 active DMFs1 inactive

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

CODY LABORATORIES INCInactiveCOCAINE HYDROCHLORIDE, USP

DMF 291202017

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

18 patents0 exclusivities▴

SOLUTION;NASAL | Approved: Jan 10, 2020

Patents (18)

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