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FOLLITROPIN ALFA/BETA - Generic Drug Details

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Follitropin alfa/beta is the generic ingredient in five branded drugs marketed by Organon Usa Inc and Emd Serono, and is included in six NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-three patent family members in thirty-eight countries.

There is one drug master file entry for follitropin alfa/beta. Two suppliers are listed for this compound.

Summary for Generic Name: FOLLITROPIN ALFA/BETA

Tradenames:5
Patents:4
Applicants:2
NDAs:6
Drug Master File Entries: (see list)1
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: FOLLITROPIN ALFA/BETA

Ingredient-typeGonadotropins
Drug ClassGonadotropin
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-003May 25, 2004RXYes7,741,268► subscribeY ► subscribe
Emd Serono
GONAL-F RFF
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-002Mar 25, 2004RXYes► subscribe► subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-001Mar 23, 2004RXYes7,446,090► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: follitropin alfa/beta

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-002Mar 23, 20044,589,402► subscribe
Emd Serono
GONAL-F RFF
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-002Mar 25, 20045,767,251► subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-003May 25, 20004,589,402► subscribe
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International Patent Family for Ingredient: follitropin alfa/beta

Country Document Number Estimated Expiration
Austria308990► subscribe
Spain2358330► subscribe
Japan4719357► 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: FOLLITROPIN ALFA/BETA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
6Finland► subscribe
C/GB10/022United Kingdom► subscribePRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
C0010Belgium► subscribePRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
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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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