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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Baxter
Argus Health
Daiichi Sankyo
Mallinckrodt
Teva
Queensland Health
Cerilliant
Chubb
Cantor Fitzgerald

Generated: February 22, 2018

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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.

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.
Summary for FOLLITROPIN ALFA/BETA
Pharmacology for FOLLITROPIN ALFA/BETA
Ingredient-typeGonadotropins
Drug ClassGonadotropin
Tentative approvals for FOLLITROPIN ALFA/BETA
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial75 IU/VIALINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
➤ Try a Free Trial➤ Try a Free Trial150 IU/VIALINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

US Patents and Regulatory Information for FOLLITROPIN ALFA/BETA

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 020378-002 Sep 29, 1997 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-003 Feb 11, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-004 Feb 28, 2001 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM follitropin alfa/beta INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020582-001 Sep 29, 1997 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-002 Mar 23, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-001 May 25, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-001 Mar 23, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 FOLLITROPIN ALFA/BETA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-004 Feb 11, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM follitropin alfa/beta INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020582-001 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM follitropin alfa/beta INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020582-002 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-003 Feb 11, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273-002 Aug 26, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for FOLLITROPIN ALFA/BETA

Supplementary Protection Certificates for FOLLITROPIN ALFA/BETA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00022 Denmark ➤ Try a Free Trial
C0010 Belgium ➤ Try a Free Trial PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
2010 Austria ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
C0024 France ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
C/GB10/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
00440 Netherlands ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
6 Finland ➤ Try a Free Trial
C019/2010 Ireland ➤ Try a Free Trial SPC019/2010: 20101001, EXPIRES: 20230112
2010000011 Germany ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
655 Luxembourg ➤ Try a Free Trial 91655, EXPIRES: 20230113
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
UBS
Harvard Business School
Mallinckrodt
Fish and Richardson
Covington
Deloitte
Federal Trade Commission

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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