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Timolol maleate - Generic Drug Details

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Timolol maleate is the generic ingredient in six branded drugs marketed by Usl Pharma, Apotex Inc, Akorn, Bausch And Lomb, Merck, Watson Labs, Valeant Pharms Llc, Pacific Pharma, Teva, Sandoz, Fdc Ltd, Alcon Res Ltd, Hi Tech Pharma, Aton, Quantum Pharmics, Fougera, Mylan, and Wockhardt, and is included in forty-three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-seven patent family members in eighteen countries.

There are fifteen drug master file entries for timolol maleate. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: timolol maleate

Tradenames:6
Patents:3
Applicants:18
NDAs:43
Drug Master File Entries: see list15
Suppliers / Packagers: see list16
Bulk Api Vendors: see list56
Clinical Trials: see list144
Patent Applications: see list5,755
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:timolol maleate at DailyMed

Pharmacology for Ingredient: timolol maleate

Tentative approvals for TIMOLOL MALEATE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION;OPHTHALMIC0.5%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
TIMOLOL MALEATE
timolol maleate
TABLET;ORAL072270-001Apr 11, 1989DISCNNoNo► subscribe► subscribe
Watson Labs
TIMOLOL MALEATE
timolol maleate
TABLET;ORAL072917-001Jul 31, 1991DISCNNoNo► subscribe► subscribe
Akorn
TIMOLOL MALEATE
timolol maleate
SOLUTION/DROPS;OPHTHALMIC074515-001Mar 25, 1997DISCNNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: timolol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aton
TIMOPTIC IN OCUDOSE
timolol maleate
SOLUTION/DROPS;OPHTHALMIC019463-002Nov 5, 19864,195,085► subscribe
Aton
TIMOPTIC
timolol maleate
SOLUTION/DROPS;OPHTHALMIC018086-001Approved Prior to Jan 1, 19823,655,663► subscribe
Valeant Pharms Llc
TIMOPTIC-XE
timolol maleate
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC020330-001Nov 4, 19934,195,085► subscribe
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Non-Orange Book Patents for Generic Ingredient: timolol maleate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,261,547 Gelling ophthalmic compositions containing xanthan gum► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: timolol maleate

Country Document Number Estimated Expiration
Japan2002510654► subscribe
Canada2322579► subscribe
Turkey200002848► 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: TIMOLOL MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
/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
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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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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