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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cerilliant
Medtronic
US Army
Federal Trade Commission
Deloitte
Covington
Mallinckrodt
Baxter

Generated: July 17, 2018

DrugPatentWatch Database Preview

GONAL-F RFF REDI-JECT Drug Profile

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Which patents cover Gonal-f Rff Redi-ject, and when can generic versions of Gonal-f Rff Redi-ject launch?

Gonal-f Rff Redi-ject is a drug marketed by Emd Serono and is included in one NDA. There are two patents protecting this drug.

This drug has sixty-five patent family members in thirty-three countries.

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.
Drug patent expirations by year for GONAL-F RFF REDI-JECT
Generic Entry Opportunity Date for GONAL-F RFF REDI-JECT
Generic Entry Date for GONAL-F RFF REDI-JECT*:
Constraining patent/regulatory exclusivity:
NDA:
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 GONAL-F RFF REDI-JECT
Ingredient-typeGonadotropins
Drug ClassGonadotropin

US Patents and Regulatory Information for GONAL-F RFF REDI-JECT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-001 May 25, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-001 May 25, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for GONAL-F RFF REDI-JECT

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 021684-002 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for GONAL-F RFF REDI-JECT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,563,763 FSH and FSH variant formulations, products and methods ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for GONAL-F RFF REDI-JECT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00440 Netherlands ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
2010000011 Germany ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
2010 Austria ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
6/2010 Austria ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Merck
Covington
Moodys
Boehringer Ingelheim
McKinsey
Citi
QuintilesIMS
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.