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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
UBS
Chinese Patent Office
Johnson and Johnson
Medtronic
Queensland Health
Healthtrust
McKesson
US Army

Generated: May 28, 2018

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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 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.
Pharmacology for follitropin alfa/beta
Ingredient-typeGonadotropins
Drug ClassGonadotropin
Tentative approvals for FOLLITROPIN ALFA/BETA
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up75 IU/VIALINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
➤ Sign Up➤ Sign Up150 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 021211-001 Mar 23, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Emd Serono GONAL-F RFF follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-002 Mar 25, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-003 Feb 11, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-002 Mar 23, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 020378-002 Sep 29, 1997 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F RFF follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-002 Mar 25, 2004 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-002 Mar 23, 2004 ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
6 Finland ➤ Sign Up
2010 Austria ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
00440 Netherlands ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKesson
Merck
McKinsey
Farmers Insurance
QuintilesIMS
Cipla
Argus Health
Harvard Business School

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