TIMOLOL - Generic Drug Details

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

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

There are fifteen drug master file entries for timolol. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for TIMOLOL

US Patents:	0
Tradenames:	8
Applicants:	34
NDAs:	61
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	243
Patent Applications:	8,075
Drug Prices:	Drug price trends for TIMOLOL
Drug Sales Revenues:	Drug sales revenues for TIMOLOL
What excipients (inactive ingredients) are in TIMOLOL?	TIMOLOL excipients list
DailyMed Link:	TIMOLOL at DailyMed

See drug prices for TIMOLOL

See drug sales revenues for TIMOLOL

Recent Clinical Trials for TIMOLOL

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

Sponsor	Phase
Kukje Pharma	Phase 2
SpyGlass Pharma, Inc.	Phase 1/Phase 2
D. Western Therapeutics Institute, Inc.	Phase 2

See all TIMOLOL clinical trials

Generic filers with tentative approvals for TIMOLOL

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

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

Medical Subject Heading (MeSH) Categories for TIMOLOL

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for TIMOLOL

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

US Patents and Regulatory Information for TIMOLOL

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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
Watson Labs	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072271-001	Apr 11, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072649-001	Jun 16, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	213540-001	Mar 23, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pacific Pharma	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	074747-001	Mar 25, 1997	AT1	RX	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-001	Mar 31, 1995	⤷ Sign Up	⤷ Sign Up
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-002	Mar 31, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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