QUIXIN Drug Patent Profile

Which patents cover Quixin, and when can generic versions of Quixin launch?

Quixin is a drug marketed by Santen and is included in one NDA.

The generic ingredient in QUIXIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Quixin

A generic version of QUIXIN was approved as levofloxacin by RISING on December 20^th, 2010.

Summary for QUIXIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	2
Patent Applications:	5,337
DailyMed Link:	QUIXIN at DailyMed

Recent Clinical Trials for QUIXIN

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

Sponsor	Phase
Roswell Park Cancer Institute	Phase 4
National Cancer Institute (NCI)	Phase 4
Children's Oncology Group	Phase 3

See all QUIXIN clinical trials

US Patents and Regulatory Information for QUIXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000		DISCN	Yes	No

Expired US Patents for QUIXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	4,382,892
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	5,503,407
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	5,053,407
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	4,551,456

EU/EMA Drug Approvals for QUIXIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A	Quinsair	levofloxacin	EMEA/H/C/002789 Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2015-03-25

International Patents for QUIXIN

See the table below for patents covering QUIXIN around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8301977
Norway	166131
Japan	H0720946
Netherlands	980016
Slovenia	8611073	PROCESS FOR PREPARING DERIVATIVES OF S(-)PYRIDOBENZOXAZINE
Spain	505116

Supplementary Protection Certificates for QUIXIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0206283	SPC/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606

QUIXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QUIXIN (Levofloxacin Ophthalmic Solution 0.5%)

Introduction to QUIXIN

QUIXIN (levofloxacin ophthalmic solution 0.5%) is a fluoroquinolone antibiotic specifically designed to treat bacterial infections of the eyes. It is the pure (-)-(S)-enantiomer of the racemic drug substance, ofloxacin, and is known for its broad-spectrum antibacterial activity against both Gram-positive and Gram-negative ocular pathogens[1].

Market Position of Fluoroquinolone Ophthalmic Solutions

Fluoroquinolone ophthalmic solutions, including QUIXIN, have become the topical antibiotic of choice for the prevention and treatment of ocular infections. These drugs are favored due to their high penetration rates into ocular tissues, broad susceptibility profiles, and their ability to reduce resistance by targeting both topoisomerase II and IV[4].

Clinical Efficacy of QUIXIN

QUIXIN has demonstrated strong clinical efficacy in treating bacterial conjunctivitis. In randomized, double-masked, multicenter controlled clinical trials, QUIXIN showed clinical cures in 79% of patients treated for bacterial conjunctivitis. Additionally, it achieved a microbial eradication rate for presumed pathogens of 90%[1].

Competitive Landscape

The market for ophthalmic antibiotics is competitive, with several other fluoroquinolones available, such as gatifloxacin (Zymaxid), moxifloxacin (Moxeza), and besifloxacin (Besivance). Each of these drugs has its unique features, such as enhanced drug penetration and resistance profiles. For instance, Besivance uses the DuraSite vehicle to prolong contact time on the ocular surface and enhance corneal penetration[4].

Pricing and Cost Considerations

The pricing of QUIXIN and other ophthalmic antibiotics can be influenced by several factors, including the cost of production, market demand, and competition. While specific pricing details for QUIXIN are not provided, it is generally understood that these medications are priced to balance profitability with patient accessibility.

Financial Performance and Revenue Streams

The financial performance of QUIXIN is tied to the overall financial health of its manufacturer and the broader market demand for ophthalmic antibiotics. Since QUIXIN is not a new drug, its revenue streams are likely stable but may fluctuate based on market competition and regulatory changes.

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of any pharmaceutical product. QUIXIN, being an FDA-approved drug, must comply with stringent regulatory requirements. Any changes in regulatory policies or the approval of new competitors can impact its market position and financial performance.

Patient and Prescriber Preferences

Patient and prescriber preferences also influence the market dynamics of QUIXIN. Factors such as ease of use, side effect profiles, and efficacy can drive prescription rates. For example, the reformulation of moxifloxacin in Moxeza to include xanthan gum, which facilitates increased corneal penetration and allows for b.i.d. dosing, has been a significant factor in its adoption[4].

Side Effects and Safety Profile

The safety profile of QUIXIN is another critical factor in its market dynamics. Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with levofloxacin. These reactions, although rare, can impact patient and prescriber confidence in the drug[1].

Pharmacokinetics and Drug Concentration

The pharmacokinetics of QUIXIN, including its concentration in plasma and tears, are important for its efficacy and safety. Studies have shown that the levofloxacin concentration in tears remains effective for several hours post-dose, which supports its clinical use[1].

Market Trends and Future Outlook

The market for ophthalmic antibiotics is evolving with the introduction of new formulations and delivery systems. Trends such as the use of novel delivery vehicles (e.g., DuraSite) and the development of drugs with no systemic counterparts (e.g., besifloxacin) are likely to shape the future of QUIXIN and similar products[4].

Key Takeaways

• Clinical Efficacy: QUIXIN has strong clinical efficacy in treating bacterial conjunctivitis.
• Market Competition: The market is competitive with several other fluoroquinolone ophthalmic solutions available.
• Regulatory Compliance: QUIXIN must comply with FDA regulations, which can impact its market position.
• Patient and Prescriber Preferences: Ease of use, side effect profiles, and efficacy drive prescription rates.
• Safety Profile: Serious hypersensitivity reactions are a rare but significant concern.

FAQs

What is QUIXIN used for?

QUIXIN (levofloxacin ophthalmic solution 0.5%) is used to treat bacterial infections of the eyes.

How effective is QUIXIN in treating bacterial conjunctivitis?

QUIXIN has demonstrated clinical cures in 79% of patients treated for bacterial conjunctivitis and achieved a microbial eradication rate of 90% for presumed pathogens.

What are the potential side effects of QUIXIN?

QUIXIN can cause serious hypersensitivity reactions, including anaphylactic reactions, cardiovascular collapse, and airway obstruction.

How does QUIXIN compare to other ophthalmic antibiotics?

QUIXIN competes with other fluoroquinolone ophthalmic solutions like gatifloxacin (Zymaxid), moxifloxacin (Moxeza), and besifloxacin (Besivance), each with unique features and advantages.

What is the regulatory status of QUIXIN?

QUIXIN is an FDA-approved drug and must comply with all relevant FDA regulations.

Sources

1. RxList: Quixin (Levofloxacin Ophthalmic Solution 0.5%) - RxList
2. Quince Therapeutics: Quince Therapeutics Provides Business Update and Reports Second Quarter 2024 Financial Results
3. WLRK: FY2014: A Year of Continuity in US M&A Antitrust Enforcement
4. Review of Optometry: Are We Gaining Ground on Ocular Infection?
5. Business Wire: Quince Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results