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Serving leading biopharmaceutical companies globally:

McKinsey
Julphar
Fish and Richardson
Medtronic
Chubb
Cipla
Boehringer Ingelheim
Harvard Business School
Daiichi Sankyo
Deloitte

Generated: February 22, 2018

DrugPatentWatch Database Preview

TIMOLOL MALEATE Drug Profile

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Which patents cover Timolol Maleate, and what generic alternatives are available?

Timolol Maleate is a drug marketed by Sandoz Inc, Akorn, Apotex Inc, Bausch And Lomb, Fdc Ltd, Fougera, Hi Tech Pharma, Pacific Pharma, Wockhardt, Mylan, Quantum Pharmics, Teva, Usl Pharma, Watson Labs, and Yaopharma Co Ltd. and is included in thirty-eight NDAs. There is one patent protecting this drug.

This drug has twenty-one patent family members in eighteen countries.

The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the timolol maleate profile page.
Summary for TIMOLOL MALEATE
Drug patent expirations by year for TIMOLOL MALEATE
Pharmacology for TIMOLOL MALEATE

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
Yaopharma Co Ltd TIMOLOL MALEATE timolol maleate TABLET;ORAL 072550-001 Apr 13, 1989 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Usl Pharma TIMOLOL MALEATE timolol maleate TABLET;ORAL 072001-001 Apr 11, 1989 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Quantum Pharmics TIMOLOL MALEATE timolol maleate TABLET;ORAL 072468-001 May 19, 1989 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Usl Pharma TIMOLOL MALEATE timolol maleate TABLET;ORAL 072002-001 Apr 11, 1989 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva TIMOLOL MALEATE timolol maleate TABLET;ORAL 072648-001 Jun 16, 1993 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pacific Pharma TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074747-001 Mar 25, 1997 AT1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan TIMOLOL MALEATE timolol maleate TABLET;ORAL 072668-003 Jun 8, 1990 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072271-001 Apr 11, 1989 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 075411-001 Sep 8, 2000 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for TIMOLOL MALEATE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,261,547 Gelling ophthalmic compositions containing xanthan gum ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for TIMOLOL MALEATE

Supplementary Protection Certificates for TIMOLOL MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/001 Belgium ➤ Try a Free 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
C0013 Belgium ➤ Try a Free Trial PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
90041 Netherlands ➤ Try a Free 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
/1999 Austria ➤ Try a Free 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
C/GB99/043 United Kingdom ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Harvard Business School
Chubb
Fuji
Cerilliant
Express Scripts
Julphar
Teva
McKesson

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