Viewing data from:

SUCRAID

BLA

SACROSIDASE | B020772 | QOL MEDCL

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

May 25, 2034(2883 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 25, 2034	Active	Computed
7-Year Orphan	Apr. 9, 2005	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 20772 | 2 presentations

351(a) ReferenceLicensedCDERSolution For Oral

Proper Name

sacrosidase

Applicant

QOL Medical, LLC

Approval Date

9-Apr-98

Orphan Exclusivity

9-Apr-05

Expired

1,003,000IU/118ML (8,500IU/ML) — Bottle (Oral)

17,000IU/2ML (8,500IU/ML) (Oral)

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

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 8,500 IU/ML

▴

SOLUTION;ORAL | Approved: 1998-04-09 00:00:00

No patent or exclusivity listings for this strength.