XELPROS Drug Patent Profile

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

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

This drug has nineteen patent family members in seventeen countries.

The generic ingredient in XELPROS is latanoprost. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xelpros

A generic version of XELPROS was approved as latanoprost by AMRING PHARMS on March 22^nd, 2011.

Summary for XELPROS

International Patents:	19
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	6,226
Drug Prices:	Drug price information for XELPROS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XELPROS
What excipients (inactive ingredients) are in XELPROS?	XELPROS excipients list
DailyMed Link:	XELPROS at DailyMed

See drug prices for XELPROS

Pharmacology for XELPROS

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for XELPROS

XELPROS is protected by two 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	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185-001	Sep 12, 2018		DISCN	Yes	No	9,539,262
Sun Pharm	XELPROS	latanoprost	EMULSION;OPHTHALMIC	206185-001	Sep 12, 2018		DISCN	Yes	No	9,629,852		Y

International Patents for XELPROS

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

Country	Patent Number	Title	Estimated Expiration
Japan	5646331
Japan	2011508724
Canada	2702478	COMPOSITION OPHTALMOLOGIQUE (OPHTHALMIC COMPOSITION)
Ukraine	100393	НОВЫЕ ОФТАЛЬМОЛОГИЧЕСКИЕ КОМПОЗИЦИИ;НОВІ ОФТАЛЬМОЛОГІЧНІ КОМПОЗИЦІЇ (NOVEL OPHTHALMIC COMPOITIONS)
Israel	205095

Supplementary Protection Certificates for XELPROS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0364417	97C0111	Belgium		PRODUCT NAME: LATANOPROSTUM; NAT. REGISTRATION NO/DATE: 277 IS 271 F 13 19970617; FIRST REGISTRATION: SE 12716 1996071
3461484	SPC/GB21/033	United Kingdom		PRODUCT NAME: A COMBINATION OF LATANOPROST AND NETARSUDIL; REGISTERED: UK EU/1/20/1502(FOR NI) 20210107; UK PLGB 16053/0034 20210107
0364417	C970039	Netherlands		PRODUCT NAME: [1R-[1 ALPHA (Z),2 BETA(R*),3 ALPHA,5ALPHA]]-7-[3,5-DIHYDROXY-2-(3-HYDROXY-5- FENYLPENTYL)CYCLOPENTYL]-5-HEPTEENZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN ESTER, IN HET BIJZONDER LATANOPROSTUM; NAT. REGISTRATION NO/DATE: RVG 21304 19970610; FIRST REGISTRATION: SE 12716 19960718
0364417	SPC/GB97/014	United Kingdom		PRODUCT NAME: LATANOPROST (I.E. 13,14-DIHYDRO-17-PHENYL-18,19,20-TRINOR-PGF-ALPHA-ISOPROPYLESTER); NAT. REGISTRATION NO/DATE: 00032/0220 19961216; FIRST REGISTRATION: SE 12716 19960718; SPC EXTENSION AUTHORISATION: PL00057/1057-008 20101216
3461484	301101	Netherlands		PRODUCT NAME: LATANOPROST OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN NETARSUDILMESYLAAT; REGISTRATION NO/DATE: EU/1/20/1502 20210108

XELPROS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XELPROS

Introduction to XELPROS

XELPROS (latanoprost ophthalmic emulsion) 0.005% is a groundbreaking medication developed by Sun Pharma for the treatment of open-angle glaucoma and ocular hypertension. It is the first and only FDA-approved benzalkonium chloride-free (BAK-free) formulation of latanoprost, making it a significant alternative in the ophthalmic market[1][4].

Market Need and Target Population

XELPROS addresses a critical need in the ophthalmic market by providing a BAK-free alternative to traditional latanoprost formulations. Benzalkonium chloride (BAK) is a preservative commonly used in eye drops but can cause inflammatory and toxic ocular effects. The absence of BAK in XELPROS makes it an attractive option for patients who experience adverse reactions to BAK-containing products[2][4].

The target population includes individuals with open-angle glaucoma or ocular hypertension, a condition characterized by elevated intraocular pressure (IOP). This condition affects a significant number of people worldwide, making XELPROS a valuable addition to the treatment options available.

Regulatory Approval and Launch

XELPROS received FDA approval in September 2018 after a thorough review process that included multiple clinical trials. The approval was a result of Sun Pharma's submission of a New Drug Application (NDA) in 2014, which underwent several revisions and resubmissions before final approval[2][4].

Following FDA approval, Sun Pharma launched XELPROS in the U.S. market, commercialized by its branded ophthalmic division, Sun Ophthalmics. This launch marked a significant milestone for Sun Pharma's growing ophthalmics division[4].

Clinical Efficacy and Safety

The efficacy and safety of XELPROS were established through several clinical trials, including a pivotal Phase 3 study (CLR_09_12) that compared XELPROS with the existing latanoprost formulation, Xalatan. While XELPROS did not establish equivalence with Xalatan in terms of the preplanned clinical endpoint, it demonstrated a significant reduction in IOP, lowering it by a mean of 5-6 mmHg[2].

The safety profile of XELPROS showed that the most frequently reported ocular adverse reactions were eye pain/stinging upon instillation and ocular hyperemia (redness), affecting 55% and 41% of patients, respectively. However, less than 1% of patients discontinued therapy due to these adverse events[1][4].

Market Access and Pricing

To enhance patient access, Sun Pharma introduced the XELPROS Xpress access program. This program allows patients to obtain XELPROS at a fixed price of $55 for a single month or $37 per month for a 3-month supply, without the need for prior authorization, step therapy, copay cards, or coupons. The program also includes prompt fulfillment services and refill reminders[1].

The pricing strategy for XELPROS is designed to balance affordability with the value provided by the BAK-free formulation. Given the niche market and the specific benefits of XELPROS, the pricing is competitive within the ophthalmic segment.

Financial Trajectory

The financial trajectory of XELPROS is influenced by several factors, including market demand, competition, and regulatory environments.

Revenue Potential

XELPROS has significant revenue potential due to its unique selling proposition as a BAK-free latanoprost formulation. The lack of generic competition in this specific niche allows Sun Pharma to capture a substantial market share. Additionally, the access program helps in ensuring consistent sales by making the product more accessible to patients[1].

Milestone Payments and Royalties

The approval and commercialization of XELPROS also trigger milestone payments and royalties to Sun Pharma Advanced Research Company (SPARC), from which Sun Pharma in-licensed the product. These payments add to the overall financial benefits derived from XELPROS[4].

Market Expansion

Sun Pharma's commitment to its ophthalmics division and the success of XELPROS are expected to drive further market expansion. The company's ability to innovate and bring new products to market, such as CEQUA (cyclosporine ophthalmic solution), reinforces its position in the ophthalmic market[4].

Competitive Landscape

The ophthalmic market, particularly for glaucoma treatments, is competitive with several existing products. However, XELPROS stands out due to its BAK-free formulation, which addresses a specific need for patients sensitive to BAK.

Generic Competition

While there are multiple generic formulations of latanoprost available, the BAK-free aspect of XELPROS differentiates it from these competitors. This differentiation is crucial in maintaining market share and pricing power[2].

Precision Medicines and Market Trends

The pharmaceutical industry is shifting towards precision medicines and products targeting smaller patient populations. XELPROS fits into this trend by offering a specialized treatment option that generates significant value for a specific patient group. This focus on precision can lead to higher prices and longer-lived profits due to reduced competition from generics[3].

Key Takeaways

• Unique Selling Proposition: XELPROS is the first and only FDA-approved BAK-free formulation of latanoprost.
• Market Access: The XELPROS Xpress access program enhances patient access and affordability.
• Clinical Efficacy: XELPROS significantly reduces IOP, with a safety profile that includes common ocular adverse reactions.
• Financial Trajectory: Significant revenue potential, milestone payments, and royalties contribute to the financial success of XELPROS.
• Competitive Landscape: Differentiation through its BAK-free formulation helps XELPROS maintain market share in a competitive ophthalmic market.

FAQs

Q: What is the primary benefit of XELPROS over other latanoprost formulations? A: The primary benefit of XELPROS is its BAK-free formulation, which makes it a safer alternative for patients who experience adverse reactions to benzalkonium chloride (BAK).

Q: How does the XELPROS Xpress access program work? A: The XELPROS Xpress access program allows patients to obtain XELPROS at a fixed price without prior authorization, step therapy, copay cards, or coupons, and includes prompt fulfillment services and refill reminders.

Q: What are the most common adverse reactions associated with XELPROS? A: The most frequently reported ocular adverse reactions are eye pain/stinging upon instillation and ocular hyperemia (redness), affecting 55% and 41% of patients, respectively.

Q: How does XELPROS fit into the broader trend of precision medicines? A: XELPROS aligns with the trend of precision medicines by targeting a specific patient population with a unique formulation, which can lead to higher prices and longer-lived profits due to reduced generic competition.

Q: Who commercializes XELPROS in the U.S. market? A: XELPROS is commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.

Sources

1. Sun Pharma Introduces Access Program for Patients Prescribed XELPROS in the U.S. - Biospace
2. FDA Approval Document for XELPROS - FDA
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - NBER
4. Sun Pharma and SPARC Announce US FDA Approval of XELPROS to Treat Open-angle Glaucoma or Ocular Hypertension - Business Wire
5. Treatment for Glaucoma | Savings With XELPROS - Xelpros.com