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Olopatadine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for olopatadine hydrochloride?

Olopatadine hydrochloride is the generic ingredient in five branded drugs marketed by Somerset Theraps Llc, Zach System Spa, Aurobindo Pharma Ltd, Akorn Inc, Novartis Pharms Corp, Barr Labs Inc, Apotex Inc, Usv North America, and Perrigo Israel, and is included in thirteen NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has forty-nine patent family members in twenty-three countries.

There are sixteen drug master file entries for olopatadine hydrochloride. Fourteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: olopatadine hydrochloride

Tradenames:5
Patents:7
Applicants:9
NDAs:13
Drug Master File Entries: see list16
Suppliers / Packagers: see list14
Bulk Api Vendors: see list73
Clinical Trials: see list995
Patent Applications: see list2,716
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:olopatadine hydrochloride at DailyMed

Pharmacology for Ingredient: olopatadine hydrochloride

Tentative approvals for OLOPATADINE HYDROCHLORIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeSOLUTION; OPHTHALMIC0.2% BASE
► Subscribe► SubscribeSOLUTION; OPHTHALMIC0.1%
► Subscribe► SubscribeSOLUTION/DROPS; OPHTHALMIC0.1%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
PAZEO
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC206276-001Jan 30, 2015RXYesYes8,791,154► SubscribeY ► Subscribe
Novartis Pharms Corp
PATANASE
olopatadine hydrochloride
SPRAY, METERED;NASAL021861-001Apr 15, 2008RXYesYes7,977,376*PED► SubscribeY► Subscribe
Usv North America
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC203152-001Dec 7, 2015RXNoNo► Subscribe► Subscribe
Somerset Theraps Llc
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC206306-001Dec 7, 2015RXNoNo► Subscribe► Subscribe
Novartis Pharms Corp
PAZEO
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC206276-001Jan 30, 2015RXYesYes9,533,053► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: olopatadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 20045,116,863*PED► Subscribe
Novartis Pharms Corp
PATANOL
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020688-001Dec 18, 19965,641,805*PED► Subscribe
Novartis Pharms Corp
PATANOL
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020688-001Dec 18, 19965,116,863*PED► Subscribe
Novartis Pharms Corp
PATANOL
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020688-001Dec 18, 19964,923,892► Subscribe
Novartis Pharms Corp
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 20045,641,805*PED► Subscribe
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International Patent Family for Ingredient: olopatadine hydrochloride

Country Document Number Estimated Expiration
South Africa200308771► Subscribe
Japan2009114213► Subscribe
TaiwanI544922► Subscribe
MexicoPA03011947► Subscribe
European Patent Office2709610► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OLOPATADINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0040France► SubscribePRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
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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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