CEQUA Drug Patent Profile

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

Cequa is a drug marketed by Sun Pharm and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-six patent family members in twenty-four countries.

The generic ingredient in CEQUA is cyclosporine. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cequa

A generic version of CEQUA was approved as cyclosporine by HIKMA on October 29^th, 1999.

Summary for CEQUA

International Patents:	36
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Patent Applications:	4,380
Drug Prices:	Drug price information for CEQUA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CEQUA
What excipients (inactive ingredients) are in CEQUA?	CEQUA excipients list
DailyMed Link:	CEQUA at DailyMed

See drug prices for CEQUA

Pharmacology for CEQUA

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for CEQUA

CEQUA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes			Y
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes			Y
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes			Y
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes			Y

International Patents for CEQUA

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2015002239	FORMULACION OFTALMICA DE LIPIDO POLIOXILO O DE ACIDO GRASO POLIOXILO Y TRATAMIENTO DE PADECIMIENTOS OCULARES. (OPHTHALMIC FORMULATION OF POLYOXYL LIPID OR POLYOXYL FATTY ACID AND TREATMENT OF OCULAR CONDITIONS.)
European Patent Office	3423076	FORMULATIONS À USAGE TOPIQUE CONTENANT DE LA CYCLOSPORINE ET LEURS UTILISATIONS (TOPICAL CYCLOSPORINE-CONTAINING FORMULATIONS AND USES THEREOF)
New Zealand	755442	Topical cyclosporine-containing formulations and uses thereof
Israel	268056	מיתכונים לשימוש חיצוני המכילים ציקלוספורין ושיטות לשימוש בהן (Topical cyclosporine-containing formulations and uses thereof)
Canada	2914472	FORMULATION OPHTALMIQUE D'ACIDE GRAS OU LIPIDIQUE DE POLYOXYLE, ET TRAITEMENT DE PATHOLOGIES OCULAIRES (OPHTHALMIC FORMULATION OF POLYOXYL LIPID OR POLYOXYL FATTY ACID AND TREATMENT OF OCULAR CONDITIONS)

Supplementary Protection Certificates for CEQUA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323

CEQUA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Cequa

Introduction to Cequa

Cequa, a cyclosporine ophthalmic solution with a concentration of 0.09% w/v, is a significant player in the ophthalmic drug market, particularly for the treatment of moderate to severe keratoconjunctivitis sicca (dry eye). Here, we delve into the market dynamics and financial trajectory of Cequa.

Market Authorization and Regulatory Approval

Cequa received market authorization from regulatory bodies such as the FDA in the United States and Health Canada. The New Drug Submission (NDS) for Cequa was approved to increase tear production and improve ocular surface signs in patients with dry eye[4].

Therapeutic Area and Unique Formulation

Cequa is distinguished by its novel formulation, which enhances the bioavailability and physicochemical stability of cyclosporine. This formulation, utilizing nanomicellar (NCELL) technology, allows for better ocular tissue penetration and faster onset of action, improving symptoms within as little as 2 weeks[5].

Market Performance and Growth

Cequa has been a standout performer in Sun Pharma's specialty portfolio. In the last quarter, Cequa's global sales surged remarkably, with a year-on-year growth of 103% in Q1FY22, outpacing competitors like Xiidra and Restasis[3].

Quarterly and Annual Growth

• Cequa's sales have shown consistent growth, with a significant increase in total prescriptions (TRx). For instance, in June 2021, Cequa clocked the highest TRx with a 79% year-on-year growth[3].
• The product's list price adjustments have also contributed to its market share. For example, a 4% price increase in April 2021 reduced the list price premium of Restasis, making Cequa more competitive[3].

Financial Impact on Sun Pharma

Cequa's strong performance has been a key driver of Sun Pharma's financial growth.

Revenue Contribution

• Cequa's sales have significantly contributed to Sun Pharma's specialty portfolio revenue. In FY22, Cequa's revenue grew substantially, and it is expected to continue this trend, with projected revenues of $100 million by FY24[3].
• The overall specialty portfolio of Sun Pharma, which includes Cequa, Ilumya, and Winlevi, saw a 28% year-on-year growth, amounting to $244 million in the last quarter[2].

Market Share and Competitive Landscape

• Cequa has gained market share rapidly, especially in the dry eye segment. Its unique formulation and faster onset of action have made it a preferred choice among ophthalmologists[5].
• Despite competition from generics like Restasis, Cequa's innovative technology and strong clinical trial data have helped it maintain a competitive edge[3].

Challenges and Future Outlook

Generic Competition

• While Cequa has shown strong growth, it is expected to face challenges from generic versions of Restasis, which could impact its sales in the future. However, its unique formulation is likely to sustain its market position[3].

R&D and Marketing Expenses

• Sun Pharma's investment in research and development (R&D) and marketing for Cequa and other specialty products is expected to continue. These expenses, although higher, are seen as necessary for maintaining market share and driving future growth[2].

Key Takeaways

• Regulatory Approval: Cequa has received regulatory approvals in key markets, including the US and Canada.
• Unique Formulation: Its nanomicellar technology enhances bioavailability and efficacy.
• Market Performance: Cequa has shown significant year-on-year growth, outpacing competitors.
• Financial Impact: It is a key contributor to Sun Pharma's specialty portfolio revenue.
• Challenges: Faces potential competition from generics but maintains a competitive edge due to its innovative formulation.

FAQs

What is Cequa used for?

Cequa is used to increase tear production and improve ocular surface signs in patients with moderate to severe keratoconjunctivitis sicca (dry eye)[4].

Who manufactures Cequa?

Cequa is manufactured by Sun Pharma, specifically through its ophthalmic division, Sun Ophthalmics[5].

What makes Cequa's formulation unique?

Cequa's formulation uses nanomicellar (NCELL) technology, which enhances the bioavailability and physicochemical stability of cyclosporine, allowing for better ocular tissue penetration and a faster onset of action[5].

How has Cequa performed in terms of sales?

Cequa has shown significant growth, with a 103% year-on-year increase in sales in Q1FY22, and it continues to be a strong performer in Sun Pharma's specialty portfolio[3].

What are the potential challenges for Cequa in the future?

Cequa may face challenges from generic versions of Restasis and other competitive products, but its unique formulation is expected to help it maintain its market position[3].

Sources

1. Mordor Intelligence: Cyclosporine Drugs Market - Size, Share & Manufacturers
2. CNBC TV18: Sun Pharma Q1 earnings expectations | Speciality drugs like Ilumya, Winlevi, Cequa to lead growth
3. Business Standard: sun pharmaceuticals
4. Health Canada: Regulatory Decision Summary for Cequa
5. Modern Optometry: CEQUA: Cyclosporine Reimagined