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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Dow
US Department of Justice
AstraZeneca
Chinese Patent Office
Mallinckrodt
Citi
Julphar
McKesson

Generated: July 19, 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 021211-002 Mar 23, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-001 Mar 25, 2004 DISCN No No ➤ 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 Y ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-002 May 25, 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
Organon Usa Inc FOLLISTIM follitropin alfa/beta INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020582-002 Sep 29, 1997 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-001 Mar 23, 2004 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM follitropin alfa/beta INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020582-002 Sep 29, 1997 ➤ 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
6 Finland ➤ Sign Up
2010 00022 Denmark ➤ Sign Up
2010000011 Germany ➤ 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:

Mallinckrodt
Citi
Cerilliant
Colorcon
Chubb
Express Scripts
Cipla
Johnson and Johnson
Harvard Business School

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.