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Serving hundreds of leading biopharmaceutical companies globally:

Merck
McKesson
Fuji
Harvard Business School
Healthtrust
Boehringer Ingelheim
QuintilesIMS
Mallinckrodt
Colorcon

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021273

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NDA 021273 describes FOLLISTIM AQ, which is a drug marketed by Organon Usa Inc and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the FOLLISTIM AQ profile page.

The generic ingredient in FOLLISTIM AQ is follitropin alfa/beta. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the follitropin alfa/beta profile page.
Summary for 021273
Tradename:FOLLISTIM AQ
Applicant:Organon Usa Inc
Ingredient:follitropin alfa/beta
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021273
Ingredient-typeGonadotropins
Suppliers and Packaging for NDA: 021273
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273 NDA Organon USA Inc. 0052-0308 N 0052-0308-02
FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273 NDA Organon USA Inc. 0052-0308 N 0052-0308-82

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength75 IU/0.5ML
Approval Date:Aug 26, 2005TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Jan 14, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength150 IU/0.5ML
Approval Date:Aug 26, 2005TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Jan 14, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN

Expired US Patents for NDA 021273

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273-002 Aug 26, 2005 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273-001 Aug 26, 2005 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273-002 Aug 26, 2005 ➤ Sign Up ➤ Sign Up
Organon Usa Inc FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021273-001 Aug 26, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Medtronic
Citi
Teva
Moodys
Cipla
Cantor Fitzgerald
Baxter

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