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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021765

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NDA 021765 describes GONAL-F RFF, which is a drug marketed by Emd Serono and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the GONAL-F RFF profile page.

The generic ingredient in GONAL-F RFF is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.

Summary for NDA: 021765

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021765

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS 021765 NDA EMD Serono, Inc. 44087-9005 44087-9005-1 1 BLISTER PACK in 1 CARTON (44087-9005-1) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 SYRINGE, GLASS (44087-9998-1) * 1 mL in 1 VIAL, SINGLE-USE
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS 021765 NDA EMD Serono, Inc. 44087-9005 44087-9005-6 10 BLISTER PACK in 1 CARTON (44087-9005-6) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 SYRINGE, GLASS (44087-9998-1) * 1 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength37.5 IU/VIAL
Approval Date:Mar 25, 2004TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength75 IU/VIAL
Approval Date:Mar 25, 2004TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength150 IU/VIAL
Approval Date:Mar 25, 2004TE:RLD:No

Expired Orange Book Patents for NDA: 021765

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-003Mar 25, 20045,767,251► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-001Mar 25, 20045,767,251► Subscribe
Emd Serono
GONAL-F RFF
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-002Mar 25, 20045,767,251► Subscribe
Emd Serono
GONAL-F RFF
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-002Mar 25, 20045,767,067► Subscribe
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Serving 500+ biopharmaceutical companies globally:

UBS
McKinsey
Chinese Patent Office
McKesson
Daiichi Sankyo
Medtronic
Boehringer Ingelheim
Novartis
Queensland Health
AstraZeneca

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