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GENOTROPIN PRESERVATIVE FREE

BLA

SOMATROPIN | B020280 | PHARMACIA

13 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

July 25, 2008(6552 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Jul. 25, 2008	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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Purdue Pharma L.P. et al v. Acura Pharmaceuticals Inc. et al 1:2016cv00256 1 patentoxycodone hydrochloride	D. Del.	2016-04-13	Terminated 2016-05-24	—
Purdue Pharma L.P. et al v. Acura Pharmaceuticals Inc. et al 1:2015cv00292 1 patentoxycodone hydrochloride	D. Del.	2015-04-03	Terminated 2016-05-24	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 20280 | 13 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

somatropin

Applicant

Pharmacia & Upjohn Company LLC

Approval Date

24-Aug-95

Orphan Exclusivity

25-Jul-08

Expired

Presentations

1.5MG — Pre-Filled Syringe (Subcutaneous)

1.4MG — Pre-Filled Syringe (Subcutaneous)

1.6MG — Pre-Filled Syringe (Subcutaneous)

1.8MG — Pre-Filled Syringe (Subcutaneous)

2MG — Pre-Filled Syringe (Subcutaneous)

5MG — Multi-Dose Cartridge (Subcutaneous)

0.6MG — Pre-Filled Syringe (Subcutaneous)

0.2MG — Pre-Filled Syringe (Subcutaneous)

0.8MG — Pre-Filled Syringe (Subcutaneous)

0.4MG — Pre-Filled Syringe (Subcutaneous)

12MG — Multi-Dose Cartridge (Subcutaneous)

1MG — Pre-Filled Syringe (Subcutaneous)

1.2MG — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

22 letters from Drugs@FDA

Date	Submission	Document
Jul 11, 2025	SUPPL -108	View Letter (PDF)
Aug 19, 2024	SUPPL -92	View Letter (PDF)
Mar 23, 2020	SUPPL -40	View Letter (PDF)
Mar 23, 2020	SUPPL -60	View Letter (PDF)
Mar 23, 2020	SUPPL -64	View Letter (PDF)
Mar 23, 2020	SUPPL -72	View Letter (PDF)
Mar 23, 2020	SUPPL -78	View Letter (PDF)
Mar 23, 2020	SUPPL -38	View Letter (PDF)
Mar 23, 2020	SUPPL -49	View Letter (PDF)
Mar 23, 2020	SUPPL -55	View Letter (PDF)
Mar 23, 2020	SUPPL -77	View Letter (PDF)
Mar 23, 2020	SUPPL -23	View Letter (PDF)
Mar 23, 2020	SUPPL -57	View Letter (PDF)
Mar 23, 2020	SUPPL -61	View Letter (PDF)
Mar 23, 2020	SUPPL -66	View Letter (PDF)
Mar 23, 2020	SUPPL -68	View Letter (PDF)
Mar 23, 2020	SUPPL -71	View Letter (PDF)
Mar 23, 2020	SUPPL -79	View Letter (PDF)
Mar 23, 2020	SUPPL -88	View Letter (PDF)
Mar 23, 2020	SUPPL -90	View Letter (PDF)
Mar 23, 2020	SUPPL -31	View Letter (PDF)
Mar 23, 2020	SUPPL -44	View Letter (PDF)

Source: Drugs@FDA application documents.