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Last Updated: October 17, 2019

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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.

Drug patent expirations by year for GONAL-F
Drug Prices for GONAL-F

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Recent Litigation for GONAL-F

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District Court Litigation
Case NameDate
Serono, Inc. v. Industria Pharmaceuticals, Inc.2004-02-13
Sereno, Inc. v. Ferring2002-09-18

See all GONAL-F litigation

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   Start Trial   Start Trial   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001 RX Yes No   Start Trial   Start Trial Y   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Emd Serono GONAL-F RFF follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-002 Mar 25, 2004 RX Yes Yes   Start Trial   Start Trial   Start Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-001 Mar 25, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001   Start Trial   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000   Start Trial   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-003 Mar 25, 2004   Start Trial   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001   Start Trial   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004   Start Trial   Start Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-001 Mar 25, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GONAL-F

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0853945 10C0024 France   Start Trial PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
0853945 C300440 Netherlands   Start Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
0853945 122010000011 Germany   Start Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
0853945 SZ 6/2010 Austria   Start Trial PRODUCT NAME: CORIFOLLITROPIN ALFA
0211894 96C0010 Belgium   Start Trial PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
0853945 6/2010 Austria   Start Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
0853945 SPC/GB10/022 United Kingdom   Start Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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