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LEVATOL

NDA

PENBUTOLOL SULFATE | N018976 | ENDO OPERATIONS LTD

2 strengths0 unique patents0 unique exclusivities

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Lannett Holdings Inc. FDA-2014-P-1883 · 6 docket documents Lannett Company, Inc. filed this petition pursuant to 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that the discontinuation of the Reference Listed Drug Levatol (Penbutolol Sulfate Tablets) in September 2014 was not for safety or effectiveness reasons, ther	505(q)	2014-11-10	Granted	Lannett Holdings Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF1 inactive

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

FINE CHEMICALS CORP PTY LTDPENBUTOLOL SULFATE

DMF 144111999

HOECHST-ROUSSEL PHARMACEUTICALS INCInactivePENBUTOLOL SULFATE (BULK FORM)

DMF 46181982

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

Products (2)

Sort:

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 30, 1987

No patent or exclusivity listings for this strength.

#004 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 5, 1989