TIMOLOL MALEATE - Generic Drug Details

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What are the generic drug sources for timolol maleate and what is the scope of patent protection?

Timolol maleate is the generic ingredient in six branded drugs marketed by Alembic, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Bausch And Lomb Inc, Bausch And Lomb, Akorn, Amring Pharms, Apotex, Apotex Inc, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sentiss Pharma, Merck, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for timolol maleate. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for TIMOLOL MALEATE

US Patents:	0
Tradenames:	6
Applicants:	29
NDAs:	54
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	66
Patent Applications:	6,505
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for TIMOLOL MALEATE
What excipients (inactive ingredients) are in TIMOLOL MALEATE?	TIMOLOL MALEATE excipients list
DailyMed Link:	TIMOLOL MALEATE at DailyMed

See drug prices for TIMOLOL MALEATE

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

Sponsor	Phase
Qlaris Bio, Inc.	Phase 2
Santen Inc.	Phase 2
Ain Shams University	Phase 4

See all TIMOLOL MALEATE clinical trials

Generic filers with tentative approvals for TIMOLOL MALEATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.5%	SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TIMOLOL MALEATE

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

Anatomical Therapeutic Chemical (ATC) Classes for TIMOLOL MALEATE

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

Paragraph IV (Patent) Challenges for TIMOLOL MALEATE

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

US Patents and Regulatory Information for TIMOLOL MALEATE

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Glossary

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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
Chartwell Rx	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072550-001	Apr 13, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	212942-002	Oct 22, 2020	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	078771-002	Sep 28, 2009	AT1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	078771-001	Sep 28, 2009	AT1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Quantum Pharmics	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072468-001	May 19, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072917-001	Jul 31, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	⤷ Sign Up	⤷ Sign Up
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Merck	BLOCADREN	timolol maleate	TABLET;ORAL	018017-004	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-001	Oct 21, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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