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Generated: March 22, 2019

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Follitropin alfa/beta - Generic Drug Details

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What are the generic drug 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 four 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.

Pharmacology for follitropin alfa/beta
Drug ClassGonadotropin
Tentative approvals for FOLLITROPIN ALFA/BETA
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial150 IU/VIALINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
➤ Try a Free Trial➤ Try a Free Trial75 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 021765-001 Mar 25, 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 021684-001 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
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 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
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273-001 Aug 26, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-001 Mar 23, 2004 ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for follitropin alfa/beta

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0853945 SZ 6/2010 Austria ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA
0211894 96C0010 Belgium ➤ Try a Free Trial PRODUCT NAME: FOLLITROPINE ALPHA; NAT. REGISTRATION NO/DATE: EU1/95/001/001 19951020; FIRST REGISTRATION: FI 11529 19940815
0853945 122010000011 Germany ➤ Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
0853945 SPC019/2010 Ireland ➤ Try a Free Trial SPC019/2010: 20101001, EXPIRES: 20230112
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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