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Last Updated: May 30, 2020

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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 Sandoz Inc, Akorn, Apotex, Apotex Inc, Bausch And Lomb, Fdc Ltd, Fougera, Hi Tech Pharma, Pacific Pharma, Wockhardt, Ani Pharms Inc, Elysium, Mylan, Quantum Pharmics, Teva, Usl Pharma, Watson Labs, and Yaopharma Co Ltd. and is included in thirty-nine 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.

US ANDA 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ain Shams UniversityPhase 4
Bausch & Lomb IncorporatedN/A
University of California, San DiegoN/A

See all TIMOLOL MALEATE clinical trials

Pharmacology for TIMOLOL MALEATE
Synonyms for TIMOLOL MALEATE
(-)-1-(tert-Butylamino)-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)-2-propanol maleate
(-)-1-(tert-Butylamino)-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)-2-propanol maleate (1:1) (salt)
(2S)-1-(tert-butylamino)-3-{[4-(morpholin-4-yl)-1,2,5-thiadiazol-3-yl]oxy}propan-2-ol (2Z)-but-2-enedioate
(S)-1-[(1,1-Dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol maleate
(S)-1-tert-Butylamino-3-(4-morpholin-4-yl-[1,2,5]thiadiazol-3-yloxy)-propan-2-ol maleate
(S)-3-(3-(tert-bUtylamino)-2-hydroxypropoxy)-4-morpholino-1,2,5-thiadiazole maleate
(S)-3-(3-(tert-Butylamino)-2-hydroxypropoxy)-4-morpholino-1,2,5-thiadiazole monomaleate
(S)-3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate
(S)-Timolol (Maleate)
(S)-Timolol hydrogen maleate
(S)-Timolol maleate
(Z)-but-2-enedioic acid;(2S)-1-(tert-butylamino)-3-[(4-morpholin-4-yl-1,2,5-thiadiazol-3-yl)oxy]propan-2-ol
1-( tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate
2-Propanol, 1-((1,1-dimethylethyl)amino)-3-((4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-, (S)-, (Z)-2-butenedioate (1:1) (salt)
2-Propanol, 1-(tert-butylamino)-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)-, (-)-, maleate (1:1) (salt)
2-Propanol, 1-(tert-butylamino)-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)-, (-)-,maleate (1:1) (salt)
26921-17-5
60469-65-0
921T175
A13429
AB0021275
AKOS024458595
AS-18090
Betime
BG0340
Bimatoprost / timolol
Blocadren
Blocadren (TN)
C13H24N4O3S.C4H4O4
CAS-26921-17-5
CCG-220948
CCRIS 1057
CHEBI:9600
CHEMBL1200870
CPD000653470
CS-1028
D00603
DSSTox_CID_27504
DSSTox_GSID_47504
DSSTox_RID_82384
DTXSID3047504
EINECS 248-111-5
EINECS 262-251-4
FT-0082529
HMS1570N18
HMS2097N18
HMS2230N19
HMS2234F03
HMS3411M12
HMS3675M12
HMS3714N18
HY-17380
Istalol (TN)
l-Timolol maleate
LS-121851
MFCD00058356
MK 950
MK-950
MLS000028539
MLS001076135
NCGC00256737-01
Opera_ID_1256
P8Y54F701R
Q-201836
Q27108445
S-(-)-1-(t-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate salt
S(-)-Timolol maleate
s4123
SAM002564238
SCHEMBL26233
SMR000058305
SMR000653470
SR-01000003102
SR-01000003102-3
Timacor
Timolol for system suitability, European Pharmacopoeia (EP) Reference Standard
Timolol hydrogen maleate
Timolol hydrogen maleate salt
Timolol hydrogenmaleate
Timolol maleate (JP17/USP)
Timolol maleate [USAN:JAN]
Timolol maleate [USAN:USP:JAN]
Timolol Maleate 1.0 mg/ml in Methanol (as free base)
Timolol maleate salt
Timolol maleate salt, >=98% (TLC), powder
Timolol maleate, British Pharmacopoeia (BP) Reference Standard
Timolol maleate, European Pharmacopoeia (EP) Reference Standard
Timolol maleate, s-enantiomer
Timolol maleate, United States Pharmacopeia (USP) Reference Standard
timolol-maleate
Timoptic
Timoptic (TN)
Timoptic in Ocudose
Timoptic-XE
Timoptic?XE
Tox21_302468
UNII-P8Y54F701R
W0079
WLRMANUAADYWEA-NWASOUNVSA-N
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
Watson Labs TIMOLOL MALEATE timolol maleate TABLET;ORAL 072269-001 Apr 11, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Quantum Pharmics TIMOLOL MALEATE timolol maleate TABLET;ORAL 072466-001 May 19, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Yaopharma Co Ltd TIMOLOL MALEATE timolol maleate TABLET;ORAL 072551-001 Apr 13, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Elysium TIMOLOL MALEATE timolol maleate TABLET;ORAL 207556-003 May 2, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Quantum Pharmics TIMOLOL MALEATE timolol maleate TABLET;ORAL 072467-001 May 19, 1989 DISCN No No   Start Trial   Start Trial   Start 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 Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-001 Oct 21, 1998   Start Trial   Start Trial
Sandoz Inc TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020963-002 Oct 21, 1998   Start Trial   Start Trial
>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   Start 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   Start 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
0227494 95C0013 Belgium   Start Trial PRODUCT NAME: TIMOLOLI MALEAS EQ. TIMOLOLUM; NATIONAL REGISTRATION/DATE: 922 IS 166 F 13 19950627; FIRST REGISTRATION: SE 11901 19930910
0509752 2000C/001 Belgium   Start 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
0509752 49/1999 Austria   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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AstraZeneca
Boehringer Ingelheim
Colorcon
Harvard Business School
Mallinckrodt

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