Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
AstraZeneca
Baxter
Colorcon
Mallinckrodt

Last Updated: August 17, 2022

TIMOLOL MALEATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Gland Pharma Ltd, Sandoz Inc, Bausch, Bausch And Lomb, Akorn, Amring Pharms, Apotex, Apotex Inc, Fdc Ltd, Fougera, Mankind Pharma, Pacific Pharma, Bausch And Lomb Inc, Merck, Ani Pharms, Chartwell Rx, Elysium, Mylan, Quantum Pharmics, Teva, Usl Pharma, and Watson Labs, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for TIMOLOL MALEATE

See drug prices for TIMOLOL MALEATE

Drug Sales Revenue Trends for TIMOLOL MALEATE

See drug sales revenues for TIMOLOL MALEATE

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
See Plans and PricingSee Plans and Pricing0.5%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
Akorn TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074465-001 Mar 25, 1997 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 075412-001 Sep 8, 2000 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-001 Nov 4, 1993 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-002 Nov 4, 1993 See Plans and Pricing See Plans and Pricing
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-004 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Bausch And Lomb Inc TIMOPTIC IN OCUDOSE timolol maleate SOLUTION/DROPS;OPHTHALMIC 019463-002 Nov 5, 1986 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.