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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
US Army
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Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021861

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NDA 021861 describes PATANASE, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PATANASE profile page.

The generic ingredient in PATANASE is olopatadine hydrochloride. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for NDA: 021861

Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021861

Suppliers and Packaging for NDA: 021861

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
olopatadine hydrochloride
SPRAY, METERED;NASAL 021861 NDA ALCON LABORATORIES, INC. 0065-0332 0065-0332-08 1 BOTTLE in 1 CARTON (0065-0332-08) > 8 SPRAY, METERED in 1 BOTTLE
olopatadine hydrochloride
SPRAY, METERED;NASAL 021861 NDA ALCON LABORATORIES, INC. 0065-0332 0065-0332-30 1 BOTTLE in 1 CARTON (0065-0332-30) > 240 SPRAY, METERED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.665MG/SPRAY
Approval Date:Apr 15, 2008TE:ABRLD:Yes
Patent:7,977,376*PEDPatent Expiration:Aug 2, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:8,399,508*PEDPatent Expiration:Mar 17, 2023Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021861

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
olopatadine hydrochloride
SPRAY, METERED;NASAL021861-001Apr 15, 20085,116,863*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Argus Health
Farmers Insurance
Fish and Richardson

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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