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Last Updated: April 16, 2024

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, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Bausch And Lomb Inc, Bausch And Lomb, Akorn, Amring Pharms, Apotex, Apotex Inc, 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-six 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:	30
NDAs:	56
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	238
Patent Applications:	8,033
Formulation / Manufacturing:	see details
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
Laboratorios Poen	Phase 4
The University of Texas Health Science Center, Houston	Phase 4
Taipei Medical University WanFang Hospital	N/A

See all timolol clinical trials

Generic filers with tentative approvals for TIMOLOL

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	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
Mylan	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072668-003	Jun 8, 1990	AB	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
Sentiss Pharma	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	217195-001	May 8, 2023	AT3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072668-002	Jun 8, 1990	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amring Pharms	TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	212592-002	Dec 13, 2021	AT3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-002	Oct 21, 1998	AB	RX	Yes	Yes	⤷ 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

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

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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 verification 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.