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BLA

PEGVISOMANT | B021106 | PHARMACIA

5 products0 Purple Book patents

Biologic LOELOE within 1 year

Estimated date when biosimilar competition may begin

July 31, 2026(28 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 31, 2026	Active	Computed
7-Year Orphan	Mar. 25, 2010	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 21106 | 5 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

pegvisomant

Applicant

Pharmacia & Upjohn Company LLC

Approval Date

25-Mar-03

Orphan Exclusivity

25-Mar-10

Expired

10MG — Single-Dose Vial (Subcutaneous)

15MG — Single-Dose Vial (Subcutaneous)

20MG — Single-Dose Vial (Subcutaneous)

25MG — Single-Dose Vial (Subcutaneous)

30MG — Single-Dose Vial (Subcutaneous)

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

Approval Letters

9 letters from Drugs@FDA

Source: Drugs@FDA application documents.