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Serving leading biopharmaceutical companies globally:

McKinsey
Chubb
Harvard Business School
AstraZeneca
Boehringer Ingelheim
McKesson
Daiichi Sankyo
Johnson and Johnson
Argus Health
Federal Trade Commission

Generated: January 23, 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.
Summary for GONAL-F
International Patents:30
US Patents:1
Applicants:1
NDAs:3
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:GONAL-F at DailyMed
Drug patent expirations by year for GONAL-F

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Emd Serono GONAL-F RFF follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-002 Mar 25, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-001 Mar 25, 2004 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-003 Mar 25, 2004 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 020378-004 Feb 28, 2001 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-001 Mar 25, 2004 ➤ Subscribe ➤ Subscribe
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for GONAL-F

Supplementary Protection Certificates for GONAL-F

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/022 United Kingdom ➤ Subscribe PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
00440 Netherlands ➤ Subscribe PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
6/2010 Austria ➤ Subscribe PRODUCT NAME: CORIFOLLITROPIN ALFA
2010000011 Germany ➤ Subscribe PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
2010 Austria ➤ Subscribe PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
C0010 Belgium ➤ Subscribe PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
C0024 France ➤ Subscribe PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Fish and Richardson
AstraZeneca
Merck
Cantor Fitzgerald
Colorcon
Queensland Health
Cipla

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.

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