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Generated: August 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021684

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NDA 021684 describes GONAL-F RFF REDI-JECT, which is a drug marketed by Emd Serono and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the GONAL-F RFF REDI-JECT profile page.

The generic ingredient in GONAL-F RFF REDI-JECT 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 021684
Tradename:GONAL-F RFF REDI-JECT
Applicant:Emd Serono
Ingredient:follitropin alfa/beta
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021684
Generic Entry Date for 021684*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021684
Ingredient-typeGonadotropins
Suppliers and Packaging for NDA: 021684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684 NDA EMD Serono, Inc. 44087-1115 N 44087-1115-1
GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684 NDA EMD Serono, Inc. 44087-1116 N 44087-1116-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 IU/0.5ML
Approval Date:May 25, 2004TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 23, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 2, 2024Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength450 IU/0.75ML
Approval Date:May 25, 2004TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 23, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021684

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 2004 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-001 May 25, 2004 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-001 May 25, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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