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Last Updated: July 31, 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 patent protection?

Timolol maleate is the generic ingredient in six branded drugs marketed by Alembic Pharms Ltd, Sandoz Inc, Valeant Pharms Llc, Bausch And Lomb, Akorn, Apotex, Apotex Inc, Fdc Ltd, Fougera, Mankind Pharma, Pacific Pharma, Valeant Pharms Intl, Merck, Ani Pharms, 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

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
⤷  Try it Free⤷  Try it Free0.5%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
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074262-001 Apr 28, 1995 AT1 RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Akorn TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 212291-001 Sep 11, 2020 AT3 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Usl Pharma TIMOLOL MALEATE timolol maleate TABLET;ORAL 072003-001 Apr 11, 1989 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apotex TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 204936-001 Apr 17, 2015 AT2 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Valeant Pharms Intl TIMOPTIC IN OCUDOSE timolol maleate SOLUTION/DROPS;OPHTHALMIC 019463-001 Nov 5, 1986 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 020330-002 Nov 4, 1993 ⤷  Try it Free ⤷  Try it Free
Valeant Pharms Intl TIMOPTIC IN OCUDOSE timolol maleate SOLUTION/DROPS;OPHTHALMIC 019463-001 Nov 5, 1986 ⤷  Try it Free ⤷  Try it Free
Valeant Pharms Intl TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Baxter
Johnson and Johnson
Dow
Moodys

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.