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ISTALOL Drug Profile

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Which patents cover Istalol, and what substitute generic drugs are available?

Istalol is a drug marketed by Bausch And Lomb and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eight patent family members in seven countries.

The generic ingredient in ISTALOL is timolol maleate. There are fifteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the timolol maleate profile page.

Summary for Tradename: ISTALOL

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list23
Patent Applications: see list5,358
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ISTALOL at DailyMed

Pharmacology for Tradename: ISTALOL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb
ISTALOL
timolol maleate
SOLUTION/DROPS;OPHTHALMIC021516-001Jun 4, 2004RXYesYes6,335,335► SubscribeY ► Subscribe
Bausch And Lomb
ISTALOL
timolol maleate
SOLUTION/DROPS;OPHTHALMIC021516-001Jun 4, 2004RXYesYes6,645,963► SubscribeY ► Subscribe
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Paragraph IV activity for: ISTALOL

Drugname Dosage Strength RLD Submissiondate
timolol maleateOphthalmic Solution0.5%Istalol10/19/2012

International Patent Family for Tradename: ISTALOL

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9922715► Subscribe
European Patent Office1029537► Subscribe
Japan4377052► Subscribe
China1278162► Subscribe
Germany69839152► 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: ISTALOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/001Belgium► SubscribePRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306
C/GB99/043United Kingdom► SubscribePRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
C0013Belgium► SubscribePRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
/1999Austria► SubscribePRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
90041Netherlands► SubscribePRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
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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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