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Last Updated: June 14, 2021

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TIMOLOL MALEATE Drug 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, Apotex, Apotex Inc, Bausch And Lomb, Fdc Ltd, Fougera, Pacific Pharma, Wockhardt, Ani Pharms Inc, Elysium, Mylan, Quantum Pharmics, Teva, Usl Pharma, Watson Labs, and Yaopharma Co Ltd. and is included in forty-one NDAs.

The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Seventeen 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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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
Usl Pharma TIMOLOL MALEATE timolol maleate TABLET;ORAL 072001-001 Apr 11, 1989 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Mylan TIMOLOL MALEATE timolol maleate TABLET;ORAL 072668-002 Jun 8, 1990 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Yaopharma Co Ltd TIMOLOL MALEATE timolol maleate TABLET;ORAL 072552-001 Apr 13, 1989 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072270-001 Apr 11, 1989 DISCN No No   Get Started Free   Get Started Free   Get Started 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
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998   Get Started Free   Get Started Free
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-002 Oct 21, 1998   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TIMOLOL MALEATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0509752 SPC/GB99/043 United Kingdom   Get Started Free 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 49/1999 Austria   Get Started Free 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   Get Started Free PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
0509752 2000C/001 Belgium   Get Started Free 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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