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Generated: September 26, 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.

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
➤ 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
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 ➤ 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 021684-003 May 25, 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
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-002 Mar 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-002 Mar 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-005 Mar 26, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for follitropin alfa/beta

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0024 France ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
6/2010 Austria ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA
C019/2010 Ireland ➤ Try a Free Trial SPC019/2010: 20101001, EXPIRES: 20230112
C0010 Belgium ➤ Try a Free Trial PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
US Army
Cantor Fitzgerald
Boehringer Ingelheim
UBS
Mallinckrodt
Daiichi Sankyo
Healthtrust

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