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GONAL-F RFF REDI-JECT

BLA

FOLLITROPIN ALFA/BETA | B021684 | EMD SERONO

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 21684 | 3 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

follitropin alfa

Applicant

EMD Serono, Inc.

Approval Date

25-May-04

Presentations

300IU/0.5ML — Autoinjector (Subcutaneous)

450IU/0.75ML — Autoinjector (Subcutaneous)

900IU/1.5ML — Autoinjector (Subcutaneous)

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
May 14, 2024	SUPPL -50	View Letter (PDF)
May 14, 2024	SUPPL -51	View Letter (PDF)
Mar 23, 2020	SUPPL -7	View Letter (PDF)
Mar 23, 2020	SUPPL -8	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 300 IU/0.5ML

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2004-05-25 00:00:00

No patent or exclusivity listings for this strength.

#002 — 450 IU/0.75ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2004-05-25 00:00:00

#003 — 900 IU/1.5ML

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INJECTABLE;SUBCUTANEOUS | Approved: 2004-05-25 00:00:00

#004 — 150 IU/0.25ML

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2004-05-25 00:00:00