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Serving leading biopharmaceutical companies globally:

McKesson
Daiichi Sankyo
McKinsey
AstraZeneca
Cipla
Cerilliant
Cantor Fitzgerald
Boehringer Ingelheim
Medtronic
Teva

Generated: February 21, 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.
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
➤ 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
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004 RX Yes Yes ➤ 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
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-003 Mar 25, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ 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
Emd Serono GONAL-F RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-001 May 25, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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
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 follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 DISCN No No ➤ Sign Up ➤ Sign Up ➤ 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 021273-001 Aug 26, 2005 DISCN No No ➤ 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 020378-005 Mar 26, 2004 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-004 Feb 11, 2005 ➤ 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
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM follitropin alfa/beta INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020582-001 Sep 29, 1997 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM follitropin alfa/beta INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 020582-002 Sep 29, 1997 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-003 Feb 11, 2004 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273-002 Aug 26, 2005 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-003 May 25, 2000 ➤ Sign Up ➤ Sign Up
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-001 Sep 29, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for follitropin alfa/beta

Country Document Number Estimated Expiration
China 1795012 ➤ Sign Up
Germany 69928296 ➤ Sign Up
Saudi Arabia 988 ➤ Sign Up
South Korea 101105486 ➤ Sign Up
South Africa 9800083 ➤ Sign Up
Norway 20054982 ➤ Sign Up
Taiwan 200503750 ➤ Sign Up
Portugal 853945 ➤ Sign Up
Portugal 1610822 ➤ Sign Up
Austria 492292 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for follitropin alfa/beta

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00022 Denmark ➤ Sign Up
655 Luxembourg ➤ Sign Up 91655, EXPIRES: 20230113
C0024 France ➤ Sign Up PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
C/GB10/022 United Kingdom ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 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
C019/2010 Ireland ➤ Sign Up SPC019/2010: 20101001, EXPIRES: 20230112
6/2010 Austria ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA
6 Finland ➤ Sign Up
2010000011 Germany ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
2010 Austria ➤ Sign Up PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
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Farmers Insurance
Queensland Health
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Argus Health
Chinese Patent Office
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Moodys

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