Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Accenture
Moodys
Deloitte
Julphar
Fish and Richardson
Novartis
Daiichi Sankyo
Farmers Insurance
Merck
US Army

Generated: January 20, 2018

DrugPatentWatch Database Preview

Timolol maleate - Generic Drug Details

« Back to Dashboard

What are the generic sources for timolol maleate and what is the scope of timolol maleate freedom to operate?

Timolol maleate
is the generic ingredient in six branded drugs marketed by Sandoz Inc, Valeant Pharms Llc, Bausch And Lomb, Akorn, Apotex Inc, Fdc Ltd, Fougera, Hi Tech Pharma, Pacific Pharma, Wockhardt, Aton, Merck, Mylan, Quantum Pharmics, Sandoz, Teva, Usl Pharma, and Watson Labs, and is included in forty-three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Timolol maleate has twenty-nine patent family members in eighteen countries.

There are fifteen drug master file entries for timolol maleate. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for timolol maleate
Tentative approvals for TIMOLOL MALEATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe0.5%SOLUTION;OPHTHALMIC

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
Mylan TIMOLOL MALEATE timolol maleate TABLET;ORAL 072668-002 Jun 8, 1990 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz TIMOLOL MALEATE timolol maleate TABLET;ORAL 072551-001 Apr 13, 1989 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072269-001 Apr 11, 1989 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Akorn TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074516-001 Mar 25, 1997 AT1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 078771-001 Sep 28, 2009 AT RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pacific Pharma TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074746-001 Mar 25, 1997 AT RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Usl Pharma TIMOLOL MALEATE timolol maleate TABLET;ORAL 072003-001 Apr 11, 1989 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aton TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Akorn TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074515-001 Mar 25, 1997 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072919-001 Jul 31, 1991 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for timolol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aton TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Aton TIMOPTIC IN OCUDOSE timolol maleate SOLUTION/DROPS;OPHTHALMIC 019463-002 Nov 5, 1986 ➤ Subscribe ➤ Subscribe
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-001 Nov 4, 1993 ➤ Subscribe ➤ Subscribe
Aton TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-002 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-004 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-002 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Aton TIMOPTIC IN OCUDOSE timolol maleate SOLUTION/DROPS;OPHTHALMIC 019463-002 Nov 5, 1986 ➤ Subscribe ➤ Subscribe
Merck BLOCADREN timolol maleate TABLET;ORAL 018017-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-001 Nov 4, 1993 ➤ Subscribe ➤ Subscribe
Aton TIMOPTIC timolol maleate SOLUTION/DROPS;OPHTHALMIC 018086-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for timolol maleate

Supplementary Protection Certificates for timolol maleate

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Dow
Accenture
AstraZeneca
US Department of Justice
Boehringer Ingelheim
Novartis
Johnson and Johnson
Argus Health

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 verifification 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.

botpot