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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
Cerilliant
Harvard Business School
Farmers Insurance
Mallinckrodt
Moodys
Merck
Colorcon
Covington

Generated: November 21, 2017

DrugPatentWatch Database Preview

FOLLITROPIN ALFA/BETA - Generic Drug Details

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What are the generic sources for follitropin alfa/beta and what is the scope of follitropin alfa/beta patent protection?

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.

Follitropin alfa/beta has one hundred and two patent family members in thirty-nine countries and eleven supplementary protection certificates in ten countries.

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

Pharmacology for FOLLITROPIN ALFA/BETA

Ingredient-typeGonadotropins
Drug ClassGonadotropin

Tentative approvals for FOLLITROPIN ALFA/BETA

Applicant Application No. Strength Dosage Form
u► Subscribe75 IU/VIALINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
u► Subscribe150 IU/VIALINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
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;SUBCUTANEOUS020378-003May 25, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-005Mar 26, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-002May 25, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-001Mar 23, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-003Feb 11, 2004DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-001Sep 29, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021273-001Aug 26, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-004Feb 11, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021273-002Aug 26, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-003May 25, 2004RXYesYes► Subscribe► 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
follitropin alfa/beta
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS020582-001Sep 29, 1997► Subscribe► Subscribe
Emd Serono
GONAL-F RFF
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021765-002Mar 25, 2004► Subscribe► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-004Feb 28, 2001► Subscribe► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-002Sep 29, 1997► Subscribe► Subscribe
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-003May 25, 2004► Subscribe► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-005Mar 26, 2004► Subscribe► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-003May 25, 2000► Subscribe► Subscribe
Emd Serono
GONAL-F
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS020378-002Sep 29, 1997► Subscribe► Subscribe
Organon Usa Inc
FOLLISTIM AQ
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021211-003Feb 11, 2004► Subscribe► Subscribe
Emd Serono
GONAL-F RFF REDI-JECT
follitropin alfa/beta
INJECTABLE;SUBCUTANEOUS021684-001May 25, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: follitropin alfa/beta

Country Document Number Estimated Expiration
Hungary227154► Subscribe
World Intellectual Property Organization (WIPO)2004087213► Subscribe
SloveniaEP0974359► Subscribe
Denmark0853945► Subscribe
Argentina043972► Subscribe
Spain2250290► Subscribe
Czech Republic297419► Subscribe
China100488566► Subscribe
Israel140984► Subscribe
Australia736339► 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
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
2010Austria► SubscribePRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
C019/2010Ireland► SubscribeSPC019/2010: 20101001, EXPIRES: 20230112
6/2010Austria► SubscribePRODUCT NAME: CORIFOLLITROPIN ALFA
655Luxembourg► Subscribe91655, EXPIRES: 20230113
2010 00022Denmark► Subscribe
2010000011Germany► 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
00440Netherlands► SubscribePRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Citi
Cipla
UBS
Federal Trade Commission
Chubb
Medtronic
Chinese Patent Office
Covington
Julphar
Daiichi Sankyo

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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