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Last Updated: June 28, 2022

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 Pharms Ltd, Sandoz Inc, Akorn, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Fdc Ltd, Fougera, Mankind Pharma, Pacific Pharma, Ani Pharms, Chartwell Rx, Elysium, Mylan, Quantum Pharmics, Teva, Usl Pharma, and Watson Labs. and is included in forty-two NDAs.

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

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

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

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

TIMOLOL MALEATE is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting TIMOLOL MALEATE

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: 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
Quantum Pharmics TIMOLOL MALEATE timolol maleate TABLET;ORAL 072467-001 May 19, 1989 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chartwell Rx TIMOLOL MALEATE timolol maleate TABLET;ORAL 072551-001 Apr 13, 1989 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072269-001 Apr 11, 1989 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva TIMOLOL MALEATE timolol maleate TABLET;ORAL 072650-001 Jun 16, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072270-001 Apr 11, 1989 DISCN No 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
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998 See Plans and Pricing See Plans and Pricing
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-002 Oct 21, 1998 See Plans and Pricing See Plans and Pricing
>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
World Intellectual Property Organization (WIPO) 9951273 See Plans and Pricing
New Zealand 506921 Gelling ophthalmic compositions containing xanthan gum See Plans and Pricing
China 1133466 See Plans and Pricing
Japan 2002510654 See Plans and Pricing
Australia 3194799 See Plans and Pricing
>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 See Plans and Pricing 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 2000C/001 Belgium See Plans and Pricing 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
0509752 C990041 Netherlands See Plans and Pricing 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 See Plans and Pricing 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
0227494 95C0013 Belgium See Plans and Pricing PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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