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Generated: September 16, 2019

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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Follitropin alfa/beta has sixty-eight patent family members in thirty-three 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
Generic filers with 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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 021211-004 Feb 11, 2005 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
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
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 020378-002 Sep 29, 1997 DISCN No No   Try a Free Trial   Try a Free Trial   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 follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-002 Mar 25, 2004 RX Yes Yes   Try a Free Trial   Try a Free Trial   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
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 021211-003 Feb 11, 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 RFF REDI-JECT follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021684-003 May 25, 2004   Try a Free Trial   Try a Free Trial
Emd Serono GONAL-F follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021765-001 Mar 25, 2004   Try a Free Trial   Try a Free Trial
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211-003 Feb 11, 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 6/2010 Austria   Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
0853945 SPC/GB10/022 United Kingdom   Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTERED: UK EU/1/09/609/001 20100125; UK EU/1/09/609/002 20100125
0853945 C300440 Netherlands   Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125; FORMER OWNER: N.V. ORGANON, NL
0853945 122010000011 Germany   Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA; REGISTRATION NO/DATE: EU/1/09/609/001-002 20100125
0853945 10C0024 France   Try a Free Trial PRODUCT NAME: CORIFOLLITROPINE ALPHA; REGISTRATION NO/DATE: EU/1/09/609/001 20100125
0853945 SZ 6/2010 Austria   Try a Free Trial PRODUCT NAME: CORIFOLLITROPIN ALFA
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
Argus Health
AstraZeneca
Chinese Patent Office
Baxter

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