Viewing data from:

FOLLISTIM AQ

BLA

FOLLITROPIN ALFA/BETA | B021211 | ORGANON USA LLC

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 21211 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

follitropin beta

Applicant

Organon USA LLC, a subsidiary of Organon & Co.

Approval Date

23-Mar-04

Presentations

300IU/0.36ML — Multi-Dose Cartridge (Subcutaneous)

600IU/0.72ML — Multi-Dose Cartridge (Subcutaneous)

175IU/0.21ML — Multi-Dose Cartridge (Subcutaneous)

900IU/1.08ML — Multi-Dose Cartridge (Subcutaneous)

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2026	SUPPL -47	View Letter (PDF)
Feb 8, 2024	SUPPL -37	View Letter (PDF)
Mar 23, 2023	SUPPL -27	View Letter (PDF)
Mar 23, 2023	SUPPL -36	View Letter (PDF)
Mar 23, 2023	SUPPL -42	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -11	View Letter (PDF)
Mar 23, 2020	SUPPL -7	View Letter (PDF)
Mar 23, 2020	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 300 IU/0.36ML

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2004-03-23 00:00:00

No patent or exclusivity listings for this strength.

#002 — 600 IU/0.72ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2004-03-23 00:00:00

#003 — 150 IU/0.18ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2004-03-23 00:00:00

#004 — 900 IU/1.08ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2004-03-23 00:00:00