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Last Updated: May 27, 2024

TIMOLOL MALEATE - Generic Drug Details


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What are the generic drug sources for timolol maleate and what is the scope of patent protection?

Timolol maleate is the generic ingredient in six branded drugs marketed by Alembic, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Bausch And Lomb Inc, Bausch And Lomb, Akorn, Amring Pharms, Apotex, Apotex Inc, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sentiss Pharma, Merck, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for timolol maleate. Twenty-five 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Qlaris Bio, Inc.Phase 2
Santen Inc.Phase 2
Ain Shams UniversityPhase 4

See all TIMOLOL MALEATE clinical trials

Generic filers with tentative approvals for TIMOLOL MALEATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up0.5%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 Strength NDA ANDAs Submitted Submissiondate
ISTALOL Ophthalmic Solution timolol maleate 0.5% 021516 1 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
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516-001 Jun 4, 2004 AT2 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 204936-001 Apr 17, 2015 AT2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms TIMOLOL MALEATE timolol maleate TABLET;ORAL 072917-001 Jul 31, 1991 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 217343-002 May 26, 2023 AT1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 214645-001 Jun 24, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising TIMOLOL MALEATE timolol maleate TABLET;ORAL 207556-003 May 2, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Bausch And Lomb Inc TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-001 Nov 4, 1993 ⤷  Sign Up ⤷  Sign Up
Sandoz TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-002 Nov 4, 1993 ⤷  Sign Up ⤷  Sign Up
Bausch And Lomb Inc TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
>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.