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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Baxter
McKesson
QuintilesIMS
Dow
Deloitte
Federal Trade Commission
Fish and Richardson
Colorcon

Generated: June 22, 2018

DrugPatentWatch Database Preview

GONAL-F Drug Profile

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When do Gonal-f patents expire, and when can generic versions of Gonal-f launch?

Gonal-f is a drug marketed by Emd Serono and is included in three NDAs. There are three patents protecting this drug.

This drug has thirty patent family members in twenty-four countries.

The generic ingredient in GONAL-F 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.

US Patents and Regulatory Information for GONAL-F

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 follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for GONAL-F

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
7,446,090 FSH formulation ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for GONAL-F

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0024 France ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
C0010 Belgium ➤ Try a Free Trial PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
6/2010 Austria ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA
2010000011 Germany ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Mallinckrodt
Cantor Fitzgerald
McKesson
Covington
Teva
Medtronic
Citi
US Army

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