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Last Updated: April 14, 2021

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Timolol maleate - Generic Drug Details

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

Timolol maleate is the generic ingredient in six branded drugs marketed by Alembic Pharms Ltd, Sandoz Inc, Valeant Pharms Llc, Bausch And Lomb, Akorn, Akorn Inc, Apotex, Apotex Inc, Fdc Ltd, Fougera, Pacific Pharma, Wockhardt, Valeant Pharms Intl, Merck, Ani Pharms Inc, Elysium, Mylan, Quantum Pharmics, Teva, Usl Pharma, Watson Labs, and Yaopharma Co Ltd, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.

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.

Drug Prices for timolol maleate

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Drug Sales Revenue Trends for timolol maleate

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Recent Clinical Trials for timolol maleate

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SponsorPhase
Santen Inc.Phase 2
Ain Shams UniversityPhase 4
Bausch & Lomb IncorporatedN/A

See all timolol maleate clinical trials

Generic filers with tentative approvals for TIMOLOL MALEATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.5%SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for timolol maleate
Paragraph IV (Patent) Challenges for TIMOLOL MALEATE
Tradename Dosage Ingredient NDA Submissiondate
ISTALOL SOLUTION/DROPS;OPHTHALMIC timolol maleate 021516 2012-10-19

US Patents and Regulatory Information for timolol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva TIMOLOL MALEATE timolol maleate TABLET;ORAL 072650-001 Jun 16, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Fougera TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074668-001 Mar 25, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex Inc TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 075412-001 Sep 8, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-002 Nov 4, 1993 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for timolol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-001 Nov 4, 1993   Start Trial   Start Trial
Valeant Pharms Intl TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516-001 Jun 4, 2004   Start Trial   Start Trial
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.