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Serving leading biopharmaceutical companies globally:

Fuji
Dow
Baxter
Chubb
Argus Health
Accenture
Julphar
McKinsey
Covington
Merck

Generated: December 11, 2017

DrugPatentWatch Database Preview

ISTALOL Drug Profile

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Which patents cover Istalol, and when can generic versions of Istalol launch?

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 and five supplementary protection certificates in four countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bausch And LombISTALOLtimolol maleateSOLUTION/DROPS;OPHTHALMIC021516-001Jun 4, 2004AT2RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bausch And LombISTALOLtimolol maleateSOLUTION/DROPS;OPHTHALMIC021516-001Jun 4, 2004AT2RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges 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
Canada2307303► Subscribe
Spain2297894► Subscribe
European Patent Office1029537► Subscribe
World Intellectual Property Organization (WIPO)9922715► Subscribe
Germany69839152► Subscribe
Japan4377052► Subscribe
China1124842► Subscribe
China1278162► 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
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
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
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
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
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Serving leading biopharmaceutical companies globally:

Cipla
US Army
Argus Health
Fish and Richardson
Dow
Johnson and Johnson
Moodys
Harvard Business School
Cantor Fitzgerald
Merck

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