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Serving leading biopharmaceutical companies globally:

Cerilliant
Mallinckrodt
Moodys
Colorcon
Novartis
UBS
Express Scripts
Citi
Accenture
Baxter

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021211

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NDA 021211 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 021211

Tradename:1
Applicant:1
Ingredient:1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 021211

Ingredient-typeGonadotropins

Suppliers and Packaging for NDA: 021211

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211 NDA Organon USA Inc. 0052-0313 0052-0313-01 1 KIT in 1 CARTON (0052-0313-01) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE
FOLLISTIM AQ follitropin alfa/beta INJECTABLE;SUBCUTANEOUS 021211 NDA Organon USA Inc. 0052-0313 0052-0313-81 1 KIT in 1 CARTON (0052-0313-81) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300 IU/0.36ML
Approval Date:Mar 23, 2004TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jan 14, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING INFERTILITY
Patent:► SubscribePatent Expiration:Jan 14, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO ANOVULATORY INFERTILE WOMEN
Patent:► SubscribePatent Expiration:Aug 23, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021211

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa IncFOLLISTIM AQfollitropin alfa/betaINJECTABLE;SUBCUTANEOUS021211-002Mar 23, 2004► Subscribe► Subscribe
Organon Usa IncFOLLISTIM AQfollitropin alfa/betaINJECTABLE;SUBCUTANEOUS021211-001Mar 23, 2004► Subscribe► Subscribe
Organon Usa IncFOLLISTIM AQfollitropin alfa/betaINJECTABLE;SUBCUTANEOUS021211-003Feb 11, 2004► Subscribe► Subscribe
Organon Usa IncFOLLISTIM AQfollitropin alfa/betaINJECTABLE;SUBCUTANEOUS021211-001Mar 23, 2004► Subscribe► Subscribe
Organon Usa IncFOLLISTIM AQfollitropin alfa/betaINJECTABLE;SUBCUTANEOUS021211-002Mar 23, 2004► Subscribe► Subscribe
Organon Usa IncFOLLISTIM AQfollitropin alfa/betaINJECTABLE;SUBCUTANEOUS021211-004Feb 11, 2005► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chinese Patent Office
Merck
US Army
Fish and Richardson
Argus Health
Baxter
Harvard Business School
UBS
McKesson

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.

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