BRIMONIDINE TARTRATE; TIMOLOL MALEATE - Generic Drug Details

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

Brimonidine tartrate; timolol maleate is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Florida, Glenmark Pharms Ltd, Sandoz, Sentiss, Somerset, Upsher Smith Labs, and Abbvie, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	13
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRIMONIDINE TARTRATE; TIMOLOL MALEATE
DailyMed Link:	BRIMONIDINE TARTRATE; TIMOLOL MALEATE at DailyMed

Recent Clinical Trials for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

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

Sponsor	Phase
Allergan	Phase 3
Allergan
Allergan	Phase 4

See all BRIMONIDINE TARTRATE; TIMOLOL MALEATE clinical trials

Generic filers with tentative approvals for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Applicant	Application No.	Strength	Dosage Form
		0.2%; 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 BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Drug Class	alpha-Adrenergic Agonist beta-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

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

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S01EA	Sympathomimetics in glaucoma therapy
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIGAN	Ophthalmic Solution	brimonidine tartrate; timolol maleate	0.2%/0.5%	021398	1	2008-11-21

US Patents and Regulatory Information for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	214987-001	May 16, 2024	AB	RX	No	No
Sandoz	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	091087-001	Apr 4, 2022	AB	RX	No	No
Alembic	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	215230-001	Aug 25, 2023	AB	RX	No	No
Somerset	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	216114-001	Sep 10, 2024	AB	RX	No	No

Expired US Patents for BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007
Abbvie	COMBIGAN	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021398-001	Oct 30, 2007

BRIMONIDINE TARTRATE; TIMOLOL MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brimonidine Tartrate and Timolol Maleate

Introduction

Brimonidine tartrate and timolol maleate ophthalmic solution is a crucial medication for managing glaucoma and ocular hypertension. This combination drug has garnered significant attention in the pharmaceutical market due to its efficacy and the growing demand for treatments of eye diseases.

Market Indications and Usage

The drug is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP[2][4][5].

Market Size and Sales

The market for brimonidine tartrate and timolol maleate ophthalmic solution is substantial. For the 12 months ending February 2023, the U.S. sales of this product were approximately $392 million[1].

Competitive Landscape

The competitive landscape for this drug includes both branded and generic versions. The original branded product, Combigan®, is developed by Allergan Ltd., while generic equivalents like the one launched by Upsher-Smith Laboratories, LLC, are also available in the market[1][4].

Product Development and Partnerships

Upsher-Smith Laboratories, LLC has expanded its ophthalmic portfolio through a strategic partnership with RAFARM UK, which includes the development and distribution of six ophthalmic and otic ANDA products. This partnership highlights the collaborative efforts in the industry to bring high-quality generic products to the market[1].

Regulatory Approvals

Brimonidine tartrate and timolol maleate ophthalmic solution has received approvals in several countries, including the United States and China. These approvals underscore the drug's efficacy and safety, which have been rigorously evaluated by regulatory authorities[4].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of brimonidine tartrate and timolol maleate ophthalmic solution. The drug has shown to reduce IOP effectively, with a safety profile that is well-tolerated by patients. Common adverse reactions include allergic conjunctivitis, conjunctival folliculosis, and eye pruritus, among others[2][3][5].

Dosage and Administration

The recommended dose is one drop of the solution in the affected eye(s) twice daily, approximately 12 hours apart. This dosing regimen is designed to maintain consistent IOP reduction throughout the day[2].

Financial Trajectory

The financial trajectory for this drug is positive, driven by the growing demand for glaucoma and ocular hypertension treatments. The $392 million in U.S. sales for the 12 months ending February 2023 indicates a robust market. As the population ages and the prevalence of glaucoma increases, the demand for this medication is expected to rise, contributing to its financial growth.

Market Growth Drivers

Several factors drive the market growth for brimonidine tartrate and timolol maleate ophthalmic solution:

• Increasing Prevalence of Glaucoma: The rising incidence of glaucoma and ocular hypertension, particularly among the aging population, drives the demand for effective treatments.
• Generic Competition: The entry of generic versions, such as the one by Upsher-Smith, increases market competition, which can lead to lower prices and higher accessibility for patients.
• Advancements in Ophthalmic Care: Continuous innovations in ophthalmic care and the development of new formulations and delivery systems contribute to market growth.

Challenges and Risks

Despite the positive market dynamics, there are challenges and risks associated with this drug:

• Adverse Reactions: While generally well-tolerated, the drug can cause severe respiratory or cardiac reactions, especially in patients with asthma or cardiac conditions[2].
• Regulatory Changes: Changes in regulatory policies or the introduction of new treatments could impact the market share and financial performance of the drug.

Patient Counseling and Safety

Patient counseling is crucial to ensure the safe use of brimonidine tartrate and timolol maleate ophthalmic solution. Patients should be informed about potential adverse reactions, proper dosing, and the importance of reporting any suspected adverse reactions to healthcare providers or regulatory authorities[2].

Conclusion

Brimonidine tartrate and timolol maleate ophthalmic solution is a vital medication in the management of glaucoma and ocular hypertension. With a strong market presence, significant sales figures, and ongoing development through strategic partnerships, this drug is poised for continued financial growth. However, it is essential to address the potential challenges and ensure patient safety through proper counseling and monitoring.

Key Takeaways

• Market Size: The U.S. sales of brimonidine tartrate and timolol maleate ophthalmic solution were approximately $392 million for the 12 months ending February 2023.
• Clinical Efficacy: The drug is effective in reducing IOP and is well-tolerated by patients.
• Regulatory Approvals: Approved in the U.S. and China, highlighting its safety and efficacy.
• Market Growth Drivers: Increasing prevalence of glaucoma, generic competition, and advancements in ophthalmic care.
• Challenges: Potential for severe adverse reactions and regulatory changes.

Frequently Asked Questions (FAQs)

1. What is the primary indication for brimonidine tartrate and timolol maleate ophthalmic solution?

The primary indication is for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP[2][4][5].

2. How is the drug administered?

One drop of the solution is administered in the affected eye(s) twice daily, approximately 12 hours apart[2].

3. What are the common adverse reactions associated with this drug?

Common adverse reactions include allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging[2][5].

4. Who are the key players in the development and distribution of this drug?

The key players include Allergan Ltd. (the originator) and Upsher-Smith Laboratories, LLC, which has launched a generic version in partnership with RAFARM UK[1][4].

5. What are the regulatory approvals for this drug?

The drug has been approved in the United States and China, indicating its efficacy and safety as evaluated by regulatory authorities[4].

Cited Sources:

1. Upsher-Smith Expands Ophthalmic Portfolio with Launch of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution. Upsher-Smith Laboratories, LLC. April 13, 2023.
2. Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution. DailyMed.
3. Clinical experience with brimonidine 0.2% and timolol 0.5%. PubMed.
4. A Comprehensive Review of Brimonidine Tartrate/Timolol Maleate's R&D Innovations. Synapse by Patsnap. October 11, 2023.
5. Brimonidine Tartrate / Timolol Ophthalmic Solution. Health Canada. December 14, 2022.