Viewing data from:

NORDITROPIN

BLA

SOMATROPIN | B021148 | NOVO NORDISK INC

11 products0 Purple Book patents

Biologic LOELOE within 1 year

Estimated date when biosimilar competition may begin

January 23, 2027(204 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 23, 2027	Active	Computed
7-Year Orphan	May. 31, 2014	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 21148 | 11 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

somatropin

Applicant

Novo Nordisk Inc.

Approval Date

20-Jun-00

Orphan Exclusivity

31-May-14

Expired

Presentations

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

15MG/1.5ML — Autoinjector (Subcutaneous)

30MG/3ML — Autoinjector (Subcutaneous)

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

15MG/1.5ML — Multi-Dose Cartridge (Subcutaneous)

5MG/1.5ML — Autoinjector (Subcutaneous)

10MG/1.5ML — Autoinjector (Subcutaneous)

15MG/1.5ML — Autoinjector (Subcutaneous)

30MG/3ML — Autoinjector (Subcutaneous)

5MG/1.5ML — Autoinjector (Subcutaneous)

10MG/1.5ML — Autoinjector (Subcutaneous)

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

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2025	SUPPL -62	View Letter (PDF)
Feb 6, 2025	SUPPL -56	View Letter (PDF)
Feb 6, 2025	SUPPL -58	View Letter (PDF)
Mar 23, 2020	SUPPL -7	View Letter (PDF)
Mar 23, 2020	SUPPL -15	View Letter (PDF)
Mar 23, 2020	SUPPL -16	View Letter (PDF)
Mar 23, 2020	SUPPL -17	View Letter (PDF)
Mar 23, 2020	SUPPL -35	View Letter (PDF)
Mar 23, 2020	SUPPL -42	View Letter (PDF)
Mar 23, 2020	SUPPL -43	View Letter (PDF)
Mar 23, 2020	SUPPL -13	View Letter (PDF)
Mar 23, 2020	SUPPL -25	View Letter (PDF)
Mar 23, 2020	SUPPL -41	View Letter (PDF)
Mar 23, 2020	SUPPL -1	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -18	View Letter (PDF)
Mar 23, 2020	SUPPL -23	View Letter (PDF)
Mar 23, 2020	SUPPL -39	View Letter (PDF)
Mar 23, 2020	SUPPL -48	View Letter (PDF)
Mar 23, 2020	SUPPL -49	View Letter (PDF)
Mar 23, 2020	SUPPL -37	View Letter (PDF)
Mar 23, 2020	SUPPL -38	View Letter (PDF)
Mar 23, 2020	SUPPL -53	View Letter (PDF)
Mar 23, 2020	SUPPL -44	View Letter (PDF)
Mar 23, 2020	SUPPL -4	View Letter (PDF)
Mar 23, 2020	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.