QOLIANA Drug Patent Profile

When do Qoliana patents expire, and when can generic versions of Qoliana launch?

Qoliana is a drug marketed by Sandoz and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in QOLIANA is brimonidine tartrate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qoliana

A generic version of QOLIANA was approved as brimonidine tartrate by BAUSCH AND LOMB on May 28^th, 2003.

Summary for QOLIANA

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	75
Patent Applications:	337
DailyMed Link:	QOLIANA at DailyMed

Pharmacology for QOLIANA

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Paragraph IV (Patent) Challenges for QOLIANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QOLIANA	Ophthalmic Solution	brimonidine tartrate	0.15%	021764	1	2023-10-24

US Patents and Regulatory Information for QOLIANA

QOLIANA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	QOLIANA	brimonidine tartrate	SOLUTION/DROPS;OPHTHALMIC	021764-001	May 22, 2006	AT	RX	Yes	Yes	7,265,117		Y

International Patents for QOLIANA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2505836	FORMULATIONS TOPIQUES DE TARTRATE DE BRIMONIDINE EXEMPTES DEDIOXYDE DE CHLORE (TOPICAL BRIMONIDINE TARTRATE FORMULATIONS THAT LACK CHLORINEDIOXIDE)

Supplementary Protection Certificates for QOLIANA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1631293	14C0056	France		PRODUCT NAME: BRIMONIDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	2014C/042	Belgium		PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221
1631293	300683	Netherlands		PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1631293	92462	Luxembourg		PRODUCT NAME: BRIMONIDINE ET SES SELS PHARMACEUTIQUES POUR L UTILISATION COMME MEDICAMENT POUR LE TRAITEMENT DES ROUGEURS INDUITES PAR LA ROSACEA.FIRST REGISTRATION: 20140225

Market Dynamics and Financial Trajectory for QOLIANA (Brimonidine Tartrate Ophthalmic Solution)

Introduction to QOLIANA

QOLIANA (brimonidine tartrate ophthalmic solution) is a selective alpha-2-adrenergic agonist used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It is available in a 0.15% concentration and is administered three times daily[1][4].

Market Context

Pharmaceutical Market Trends

The pharmaceutical market, particularly for ophthalmic solutions, is influenced by several factors including the number of competitors, the efficacy of the drug, and the cost of research and development. New brand-name drugs, such as QOLIANA, are often more expensive than generics due to these factors[2].

Competitive Landscape

QOLIANA competes in the market for glaucoma treatments, which includes other alpha-2 adrenergic agonists like Alphagan P. The competitive landscape is characterized by the presence of both brand-name and generic drugs. QOLIANA has been shown to be equivalent in intraocular pressure (IOP)-lowering effect to Alphagan P, making it a viable option in this market segment[1][4].

Financial Aspects

Pricing and Cost

The pricing of QOLIANA, like many pharmaceuticals, is influenced by various factors including research and development costs, market competition, and the need to generate profits for shareholders. The cost of QOLIANA can vary depending on the region and the presence of generic alternatives. In general, brand-name drugs tend to be more expensive than their generic counterparts[2].

Rebates and Discounts

Pharmaceutical companies often offer rebates to certain types of purchasers, such as pharmacy benefit managers (PBMs), which can affect the final net price received by the manufacturer. These rebates can significantly impact the financial trajectory of a drug by reducing the revenue per unit sold[2].

Revenue and Sales Projections

Market Demand

The demand for glaucoma treatments is driven by the prevalence of the disease and the need for effective management of intraocular pressure. Given that QOLIANA is effective in lowering IOP, it is likely to maintain a steady market demand, especially in regions where access to healthcare is high.

Sales Performance

QOLIANA's sales performance would be influenced by its market share within the glaucoma treatment segment. As a brand-name drug, it would initially benefit from marketing exclusivity, but this period has been observed to decrease over time, allowing for quicker entry of generic competitors[3].

Regulatory and Approval Process

FDA Approval and Labeling

QOLIANA received FDA approval through a supplemental new drug application (sNDA) under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. This approval process involves rigorous clinical studies and labeling revisions, which can impact the drug's market entry and subsequent sales[5].

Side Effects and Safety Profile

Impact on Market Perception

The safety profile of QOLIANA, including common side effects such as eye redness, inflammation, and itching, can influence patient and physician preferences. A favorable safety profile can enhance market acceptance and adherence to the treatment regimen[1][4].

Concomitant Use with Other Medications

Drug Interactions

QOLIANA can be used concomitantly with other topical ophthalmic products, but caution is advised when using it with certain systemic medications such as anti-hypertensives, CNS depressants, and tricyclic antidepressants. These interactions can affect the drug's market dynamics by influencing prescribing patterns[4].

Pricing Transparency and Regulatory Scrutiny

Price Transparency Reports

Prescription drug price transparency reports highlight the significant variations in drug prices across different regions and the impact of rebates and discounts on the final cost. Such reports can influence regulatory scrutiny and public perception, potentially affecting the financial trajectory of QOLIANA[2].

Global Market Considerations

International Pricing

The price of QOLIANA can vary significantly across different countries due to local regulatory environments, healthcare systems, and market competition. This variability can impact the drug's global sales and revenue projections[2].

Key Takeaways

• Market Competition: QOLIANA competes in a market with both brand-name and generic glaucoma treatments.
• Pricing Dynamics: Influenced by R&D costs, market competition, and rebates.
• Regulatory Approval: FDA approval through sNDA with ongoing labeling revisions.
• Safety Profile: Common side effects include eye redness and inflammation.
• Concomitant Use: Caution advised with certain systemic medications.
• Global Market: Pricing varies significantly across different countries.

FAQs

1. What is QOLIANA used for?

QOLIANA (brimonidine tartrate ophthalmic solution) is used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

2. How is QOLIANA administered?

QOLIANA is administered as one drop in the affected eye(s) three times daily, approximately 8 hours apart.

3. What are the common side effects of QOLIANA?

Common side effects include eye redness, inflammation, itching, and tearing.

4. Can QOLIANA be used with other ophthalmic products?

Yes, QOLIANA may be used concomitantly with other topical ophthalmic products, but the products should be administered at least 5 minutes apart.

5. Is QOLIANA available in generic form?

Yes, QOLIANA is available in generic form, which can affect its market pricing and competition.

Cited Sources

1. RxList: Qoliana (Brimonidine Tartrate Ophthalmic Solution) - RxList
2. Oregon Department of Consumer and Business Services: Prescription Drug Price Transparency Results and Recommendations
3. PubMed: The economics of follow-on drug research and development
4. MedicineNet: Qoliana: Glaucoma Eye Drops Uses, Side Effects, Dosage
5. FDA: QOLIANA (brimonidine tartrate ophthalmic solution) 0.15% - FDA Approval Letter