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Generated: May 25, 2017

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Timolol maleate - Generic Drug Details

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What are the generic sources for timolol maleate and what is the scope of timolol maleate freedom to operate?

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, Sandoz Inc, Hi Tech Pharma, Aton, Quantum Pharmics, Fougera, Mylan, and Wockhardt, and is included in forty-three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Timolol maleate has twenty-seven patent family members in eighteen countries.

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

Summary for Generic Name: timolol maleate

Drug Master File Entries: see list15
Suppliers / Packagers: see list17
Bulk Api Vendors: see list56
Clinical Trials: see list144
Patent Applications: see list6,914
Therapeutic Class: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. Strength Dosage Form
► Subscribe► Subscribe0.5%SOLUTION;OPHTHALMIC
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
timolol maleate
TABLET;ORAL072917-001Jul 31, 1991DISCNNoNo► Subscribe► Subscribe
Apotex Inc
timolol maleate
SOLUTION/DROPS;OPHTHALMIC075412-001Sep 8, 2000DISCNNoNo► Subscribe► Subscribe
Sandoz Inc
timolol maleate
SOLUTION/DROPS;OPHTHALMIC074261-001Apr 28, 1995ATRXNoYes► Subscribe► Subscribe
Quantum Pharmics
timolol maleate
TABLET;ORAL072466-001May 19, 1989DISCNNoNo► Subscribe► Subscribe
timolol maleate
TABLET;ORAL072668-001Jun 8, 1990RXNoYes► Subscribe► Subscribe
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