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Last Updated: March 28, 2024

TIMOLOL MALEATE Drug Patent Profile


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When do Timolol Maleate patents expire, and when can generic versions of Timolol Maleate launch?

Timolol Maleate is a drug marketed by Alembic, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Akorn, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sentiss Pharma, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs. and is included in forty-nine NDAs.

The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Timolol Maleate

A generic version of TIMOLOL MALEATE was approved as timolol maleate by MYLAN on June 8th, 1990.

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Drug patent expirations by year for TIMOLOL MALEATE
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
Qlaris Bio, Inc.Phase 2
Santen Inc.Phase 2
Ain Shams UniversityPhase 4

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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
Ani Pharms TIMOLOL MALEATE timolol maleate TABLET;ORAL 072919-001 Jul 31, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Micro Labs TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 216596-001 Sep 7, 2022 AT3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Quantum Pharmics TIMOLOL MALEATE timolol maleate TABLET;ORAL 072467-001 May 19, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072269-001 Apr 11, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Sandoz TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sandoz TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-002 Oct 21, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TIMOLOL MALEATE

See the table below for patents covering TIMOLOL MALEATE around the world.

Country Patent Number Title Estimated Expiration
Portugal 1069913 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9951273 ⤷  Try a Trial
Canada 2322579 COMPOSITIONS OPHTALMIQUES GELIFIANTES, CONTENANT DE LA GOMME DE XANTHANNE (GELLING OPHTHALMIC COMPOSITIONS CONTAINING XANTHAN GUM) ⤷  Try a Trial
Turkey 200002848 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TIMOLOL MALEATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0509752 SPC/GB99/043 United Kingdom ⤷  Try a Trial PRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
0509752 C990041 Netherlands ⤷  Try a Trial PRODUCT NAME: DORZOLAMIDE, DESGEWENST IN DE VORM VAN EEN OFTALMOLOGISCH AAN- VAARDBAAR ZOUT, EN TIMOLOL, DESGEWENST IN DE VORM VAN EEN OFTAL -MOLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER DORZOLLAMIDEHY- DROCHLORIDE EN TIMOLOLMALEAAT, EEN EN ANDER ZODANIG DAT 0,05; NATL REGISTRATION NO/DATE: VG 22871 19980805; FIRST REGISTRATION: DK 19045 19980306
0509752 49/1999 Austria ⤷  Try a Trial PRODUCT NAME: DORZOLAMID ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE DORZOLAMIDHYDROCHLORID, UND TIMOLOL ODER EIN OPHTHALMOLOGISCH ANNEHMBARES SALZ DAVON, VORZUGSWEISE TIMOLOLMALEAT; NAT. REGISTRATION NO/DATE: 1-22701, 1-22702 19980828; FIRST REGISTRATION: DK 9794 19980306
0509752 2000C/001 Belgium ⤷  Try a Trial PRODUCT NAME: DORZOLAMIDI HYDROCHLORIDUM EQ. DORZOLAMIDUM, TIMOLOLI MALEAS EQ. TIMOLOLUM; NAT. REGISTRATION NO/DATE: 922 IS 180 F 13 19981110; FIRST REGISTRATION: DK 19045 19980306
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.