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SURVANTA

BLA

BERACTANT | B020032 | ABBVIE

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

July 2, 1998(10228 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Jul. 2, 1998	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

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

Purple Book (Biologics)

BLA 20032 | 2 presentations

351(a) ReferenceLicensedCDERSuspension

Proper Name

beractant

Applicant

AbbVie Inc.

Approval Date

1-Jul-91

Orphan Exclusivity

2-Jul-98

Expired

100MG/4ML (25MG/ML) — Single-Dose Vial (Intratracheal)

200MG/8ML (25MG/ML) — Single-Dose Vial (Intratracheal)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/ML

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SUSPENSION;INTRATRACHEAL | Approved: 1991-07-01 00:00:00

No patent or exclusivity listings for this strength.