Viewing data from:

OMNITROPE

BLA

SOMATROPIN | B021426 | SANDOZ

4 products0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in 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 21426 | 4 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

somatropin

Applicant

Sandoz Inc.

Approval Date

30-May-06

Presentations

5.8MG — Multi-Dose Vial (Subcutaneous)

1.5MG — Single-Dose Vial (Subcutaneous)

5MG/1.5ML — Multi-Dose Cartridge (Subcutaneous)

10MG/1.5ML — Multi-Dose Cartridge (Subcutaneous)

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2025	SUPPL -62	View Letter (PDF)
Nov 13, 2024	SUPPL -43	View Letter (PDF)
Nov 13, 2024	SUPPL -58	View Letter (PDF)
Jan 28, 2022	SUPPL -50	View Letter (PDF)
Mar 23, 2020	SUPPL -7	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -2	View Letter (PDF)
Mar 23, 2020	SUPPL -4	View Letter (PDF)
Mar 23, 2020	SUPPL -18	View Letter (PDF)
Mar 23, 2020	SUPPL -28	View Letter (PDF)
Mar 23, 2020	SUPPL -34	View Letter (PDF)
Mar 23, 2020	SUPPL -17	View Letter (PDF)
Mar 23, 2020	SUPPL -6	View Letter (PDF)
Mar 23, 2020	SUPPL -8	View Letter (PDF)
Mar 23, 2020	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5.8MG/VIAL

▴

INJECTABLE;INJECTION | Approved: 2006-05-30 00:00:00

No patent or exclusivity listings for this strength.

#002 — 1.5MG/VIAL

▾

INJECTABLE;INJECTION | Approved: 2006-05-30 00:00:00

#003 — 5MG/1.5ML

▾

INJECTABLE;INJECTION | Approved: 2006-05-30 00:00:00

#004 — 10MG/1.5ML

▾

INJECTABLE;INJECTION | Approved: 2006-05-30 00:00:00