TIMOLOL MALEATE Drug Patent Profile

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Timolol Maleate is a drug marketed by Alembic, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Akorn, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sentiss Pharma, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs. and is included in forty-nine NDAs.

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

A generic version of TIMOLOL MALEATE was approved as timolol maleate by MYLAN on June 8^th, 1990.

US Patents:	0
Applicants:	27
NDAs:	49
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	66
Patent Applications:	4,690
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIMOLOL MALEATE
What excipients (inactive ingredients) are in TIMOLOL MALEATE?	TIMOLOL MALEATE excipients list
DailyMed Link:	TIMOLOL MALEATE at DailyMed

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

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

C07AA	Beta blocking agents, non-selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

S01ED	Beta blocking agents
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ISTALOL	Ophthalmic Solution	timolol maleate	0.5%	021516	1	2012-10-19

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072919-001	Jul 31, 1991		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Micro Labs	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	216596-001	Sep 7, 2022	AT3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Quantum Pharmics	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072467-001	May 19, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-001	Oct 21, 1998	⤷ Try a Trial	⤷ Try a Trial
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-002	Oct 21, 1998	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering TIMOLOL MALEATE around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1069913	COMPOSITIONS OPHTALMIQUES GELIFIANTES, CONTENANT DE LA GOMME DE XANTHANNE (GELLING OPHTHALMIC COMPOSITIONS CONTAINING XANTHAN GUM)	⤷ Try a Trial
Turkey	200002848		⤷ Try a Trial
Austria	245451		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0509752	C990041	Netherlands	⤷ Try a 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
0509752	2000C/001	Belgium	⤷ Try a 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
0227494	95C0013	Belgium	⤷ Try a Trial	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