Viewing data from:

ALUPENT

NDA

METAPROTERENOL SULFATE | N018761 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs3 inactive

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

LUSOCHIMICA SPAMETAPROTERENOL SULFATE

DMF 53271984

CAMBREX PROFARMACO MILANO SRLMETAPROTERENOL SULFATE

DMF 81291989

LABOCHIM SPAInactiveMETAPROTERENOL SULFATE USP

DMF 68351987

JVL CORPInactiveMETAPROTERENOL SULFATE

DMF 70101987

CIPLA LTDInactiveMETAPROTERENOL SULFATE

DMF 77171988

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 23, 2002	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.6%

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Jun 30, 1983

No patent or exclusivity listings for this strength.

#002 — 0.4%

0 patents0 exclusivities▾

SOLUTION;INHALATION | Approved: Oct 10, 1986