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GONAL-F Drug Profile

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

This drug has twenty-eight 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 Tradename: GONAL-F

Patents:3
Applicants:1
NDAs:3
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-001Mar 25, 2004DISCNNo► subscribe► subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-004Feb 28, 2001RXNo7,563,763► subscribeY ► subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-001Sep 29, 1997DISCNNo► subscribe► subscribe
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Expired Patents for Tradename: GONAL-F

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-001Mar 25, 20045,767,251► subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-001Sep 29, 19974,589,402► subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-003May 25, 20004,589,402► subscribe
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Non-Orange Book Patents for Tradename: 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
7,446,090FSH formulation► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: GONAL-F

Country Document Number Estimated Expiration
Indonesia28747► subscribe
Japan4719357► subscribe
Japan2002521342► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GONAL-F

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0010Belgium► subscribePRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
2010Austria► subscribePRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
C0024France► subscribePRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
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