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Serving 500+ biopharmaceutical companies globally:

UBS
Cantor Fitzgerald
US Army
Colorcon
Cerilliant
Novartis
Johnson and Johnson
Cipla
Fuji
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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019415

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NDA 019415 describes FERTINEX, which is a drug marketed by Serono and is included in one NDA. Additional details are available on the FERTINEX profile page.

The generic ingredient in FERTINEX is urofollitropin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the urofollitropin profile page.

Summary for NDA: 019415

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULARStrength75 IU/AMP
Approval Date:Sep 18, 1986TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULARStrength150 IU/AMP
Approval Date:Sep 18, 1986TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrength150 IU/AMP
Approval Date:Aug 23, 1996TE:RLD:No

Expired Orange Book Patents for NDA: 019415

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Serono
FERTINEX
urofollitropin
INJECTABLE;SUBCUTANEOUS019415-005Aug 23, 19965,767,067► Subscribe
Serono
FERTINEX
urofollitropin
INJECTABLE;SUBCUTANEOUS019415-004Aug 23, 19964,725,579► Subscribe
Serono
FERTINEX
urofollitropin
INJECTABLE;SUBCUTANEOUS019415-004Aug 23, 19964,845,077► Subscribe
Serono
FERTINEX
urofollitropin
INJECTABLE;SUBCUTANEOUS019415-005Aug 23, 19964,589,402► Subscribe
Serono
FERTINEX
urofollitropin
INJECTABLE;SUBCUTANEOUS019415-004Aug 23, 19964,589,402► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Teva
Novartis
Farmers Insurance
QuintilesIMS
AstraZeneca
Johnson and Johnson
US Department of Justice
Chubb
Citi
Medtronic

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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