Viewing data from:

HUMATROPE

BLA

SOMATROPIN | B019640 | LILLY

5 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

November 1, 2013(4627 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Nov. 1, 2013	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 19640 | 5 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

somatropin

Applicant

Eli Lilly and Company

Approval Date

23-Jun-87

Orphan Exclusivity

1-Nov-13

Expired

2MG — Single-Dose Vial (Subcutaneous)

5MG — Single-Dose Vial (Subcutaneous)

6MG — Multi-Dose Cartridge (Subcutaneous)

12MG — Multi-Dose Cartridge (Subcutaneous)

24MG — Multi-Dose Cartridge (Subcutaneous)

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

Approval Letters

22 letters from Drugs@FDA

Source: Drugs@FDA application documents.