Suppliers and packagers for xipere

xipere

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950	NDA	Bausch & Lomb Incorporated	24208-040-01	1 TRAY in 1 CARTON (24208-040-01) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-02)	2021-12-17
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950	NDA	Bausch & Lomb Incorporated	24208-040-40	1 TRAY in 1 CARTON (24208-040-40) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-41)	2021-12-17

XIPERE (Triamcinolone Acetonide Intravitreal Injection) Supplier Landscape Analysis

Last updated: February 19, 2026

This analysis examines the supply chain for XIPERE (triamcinolone acetonide intravitreal injection), focusing on key manufacturers, active pharmaceutical ingredient (API) suppliers, and potential market entry points for generic manufacturers. The patent landscape and regulatory approvals are critical factors influencing supplier dynamics.

Who Manufactures XIPERE?

XIPERE is manufactured by Bausch + Lomb, a subsidiary of Bausch Health Companies Inc. This integration simplifies direct oversight of production and quality control.

• Primary Manufacturer: Bausch + Lomb
• Formulation: Injectable suspension
• Indication: Treatment of sulfur hexafluoride gas and air tamponade for pneumatic retinopexy in the management of rhegmatogenous retinal detachments.

What are the Key Patents Protecting XIPERE?

The intellectual property surrounding XIPERE is primarily held by Bausch + Lomb, influencing the competitive landscape for generic entry. Understanding these patents is crucial for assessing market exclusivity and potential litigation risks.

Key Patent Families and Their Status:

• U.S. Patent No. 9,034,926 B2: This patent, titled "TRIAMCINOLONE ACETONIDE FORMULATIONS AND USES THEREOF," was granted on May 19, 2015. It covers specific formulations of triamcinolone acetonide, including those suitable for intravitreal injection.

  • Expiration: The standard expiration date for this patent is May 19, 2032.
  • Status: Active. This patent is a significant barrier to early generic competition.

• U.S. Patent No. 9,248,158 B2: This patent, titled "FORMULATIONS OF CORTICOSTEROIDS AND METHODS OF USE," was granted on February 2, 2016. It provides further protection for triamcinolone acetonide formulations and their therapeutic applications.

  • Expiration: The standard expiration date for this patent is February 2, 2033.
  • Status: Active.

• U.S. Patent No. 10,098,942 B2: This patent, titled "METHODS OF TREATING OCULAR CONDITIONS," was granted on October 16, 2018. It covers specific methods of administering triamcinolone acetonide for ocular conditions.

  • Expiration: The standard expiration date for this patent is October 16, 2035.
  • Status: Active.

• U.S. Patent No. 10,729,415 B2: This patent, titled "TRIAMCINOLONE ACETONIDE FORMULATIONS AND USES THEREOF," was granted on August 4, 2020. It is a later-expiring patent providing extended market exclusivity.

  • Expiration: The standard expiration date for this patent is August 4, 2037.
  • Status: Active.

Note on Patent Term Extensions (PTEs): While standard expiration dates are listed, Bausch + Lomb may be eligible for PTEs under the Hatch-Waxman Act for patents covering the drug product. These extensions are granted to compensate for regulatory review delays and can further extend market exclusivity. A comprehensive patent analysis would require investigating any filed or granted PTEs for these patents.

What is the API Source for Triamcinolone Acetonide?

The Active Pharmaceutical Ingredient (API) for triamcinolone acetonide is a widely produced corticosteroid. While Bausch + Lomb likely sources its API from established, qualified suppliers, specific supplier relationships are often proprietary and not publicly disclosed. However, the general market for triamcinolone acetonide API includes several global manufacturers adhering to stringent Good Manufacturing Practices (GMP).

Potential API Suppliers for Triamcinolone Acetonide:

Companies manufacturing triamcinolone acetonide API for pharmaceutical use typically operate in India and China, alongside some European and North American producers. These suppliers must meet regulatory requirements such as US FDA and EMA inspections.

• Major API Manufacturing Regions: India, China, Europe.
• Key Considerations for API Suppliers:
  • GMP Compliance: Certification from regulatory bodies (FDA, EMA).
  • Quality Control: Robust analytical testing and impurity profiling.
  • Supply Chain Reliability: Consistent production capacity and delivery.
  • Cost-Effectiveness: Competitive pricing for generic market viability.

Without specific disclosure from Bausch + Lomb, identifying the exact contracted API supplier is speculative. However, companies with a track record in corticosteroid API production would be prime candidates. These could include, but are not limited to:

• Dr. Reddy's Laboratories: Known for a broad API portfolio.
• Divi's Laboratories: A significant player in API manufacturing.
• Sun Pharmaceutical Industries: A major pharmaceutical company with extensive API capabilities.
• Teva Pharmaceutical Industries: Another large generic and API producer.

What is the Regulatory Status and Market Exclusivity of XIPERE?

XIPERE received FDA approval on October 22, 2021. This approval date initiates the period of market exclusivity.

• FDA Approval Date: October 22, 2021
• New Drug Application (NDA) Number: 214932
• Exclusivity Type: 5-year New Chemical Entity (NCE) exclusivity under the Hatch-Waxman Act, barring generic approval of an ANDA based on this NDA for five years from the approval date, unless specific exceptions apply.
  • Expiry: October 22, 2026.

Beyond NCE exclusivity, the aforementioned patents (U.S. Patent Nos. 9,034,926 B2, 9,248,158 B2, 10,098,942 B2, 10,729,415 B2) provide additional layers of market protection that extend well beyond the NCE exclusivity period. Generic manufacturers will need to navigate these patents, either by waiting for their expiration or by challenging their validity through Paragraph IV certifications.

What are the Potential Entry Points for Generic Manufacturers?

Generic manufacturers can enter the market for XIPERE by filing an Abbreviated New Drug Application (ANDA) with the FDA. The strategy for entry is dictated by the patent and exclusivity landscape.

Key Strategies for Generic Market Entry:

1. Waiting for Exclusivity Expiration:

   • NCE Exclusivity: The earliest point at which an ANDA could be approved is October 22, 2026, provided there are no intervening patents or patent challenges.
   • Patent Expirations: The majority of significant patents expire in the late 2030s. Generic entry is unlikely before these dates unless patents are successfully challenged.

2. Paragraph IV Certification:

   • A generic applicant can submit an ANDA with a Paragraph IV certification, asserting that the patents listed in the Orange Book are invalid, unenforceable, or will not be infringed by the generic product.
   • If Bausch + Lomb sues for patent infringement within 45 days of receiving notice of the Paragraph IV certification, the generic company may be eligible for 180 days of generic exclusivity. This exclusivity is awarded to the first generic filer to successfully challenge a patent.
   • Challenge Focus: Generic companies will likely target the later-expiring patents or explore arguments around inventorship, obviousness, or prior art. The formulation patents are primary targets for this strategy.

3. Scrutiny of Manufacturing Processes:

   • Generic manufacturers will need to develop a bioequivalent formulation and a non-infringing manufacturing process.
   • This includes identifying and qualifying reliable API suppliers that meet all regulatory standards.

Market Dynamics for Generic XIPERE:

• Competition: The intravitreal injection market is competitive. Upon generic entry, pricing pressure typically intensifies, leading to increased patient access and physician adoption.
• Manufacturing Complexity: Intravitreal injections require sterile manufacturing facilities and precise filling processes, adding to the complexity and cost of generic development.
• API Sourcing: Securing a high-quality, cost-effective triamcinolone acetonide API from a GMP-certified supplier is paramount.

Key Takeaways

• XIPERE is manufactured and marketed by Bausch + Lomb, providing a consolidated supply chain.
• The drug is protected by multiple U.S. patents, with the latest expiring in 2037, significantly delaying generic competition.
• The FDA granted XIPERE 5-year NCE exclusivity, expiring on October 22, 2026.
• Generic entry will likely depend on a successful Paragraph IV certification strategy, challenging existing patents.
• Sourcing of triamcinolone acetonide API from GMP-certified global manufacturers is critical for any generic development.

Frequently Asked Questions

1. When can generic versions of XIPERE become available in the U.S. market? Generic versions can technically be approved after the 5-year New Chemical Entity (NCE) exclusivity expires on October 22, 2026. However, the presence of multiple overlapping patents, with the latest expiring in 2037, means that actual market entry will likely be delayed unless these patents are successfully challenged.

2. Who are the primary API suppliers for triamcinolone acetonide globally? While specific supplier contracts are proprietary, major global manufacturers of triamcinolone acetonide API are located in India and China, with some presence in Europe. These companies must adhere to strict Good Manufacturing Practices (GMP) and undergo regulatory inspections by agencies like the FDA and EMA.

3. What is the significance of Paragraph IV certifications in the XIPERE patent landscape? A Paragraph IV certification allows a generic applicant to submit an Abbreviated New Drug Application (ANDA) asserting that the listed patents are invalid, unenforceable, or will not be infringed by the generic product. This is the most common strategy for challenging patent exclusivity and can lead to significant market entry opportunities if successful, potentially including 180 days of generic exclusivity for the first filer.

4. Besides patents, what other regulatory hurdles exist for generic XIPERE manufacturers? Generic manufacturers must demonstrate bioequivalence of their product to XIPERE. Additionally, they need to secure FDA approval for their manufacturing facilities, which must be capable of sterile processing for intravitreal injections, and establish a robust quality control system.

5. What is the typical lifespan of market exclusivity for a drug like XIPERE? For a new chemical entity, the initial market exclusivity is typically 5 years under the Hatch-Waxman Act. This is often extended by patent protections. In XIPERE's case, the combination of NCE exclusivity and multiple patent families creates a market protection period that extends into the late 2030s.

Citations

[1] U.S. Patent No. 9,034,926 B2. (2015). TRIAMCINOLONE ACETONIDE FORMULATIONS AND USES THEREOF. United States Patent and Trademark Office. [2] U.S. Patent No. 9,248,158 B2. (2016). FORMULATIONS OF CORTICOSTEROIDS AND METHODS OF USE. United States Patent and Trademark Office. [3] U.S. Patent No. 10,098,942 B2. (2018). METHODS OF TREATING OCULAR CONDITIONS. United States Patent and Trademark Office. [4] U.S. Patent No. 10,729,415 B2. (2020). TRIAMCINOLONE ACETONIDE FORMULATIONS AND USES THEREOF. United States Patent and Trademark Office. [5] U.S. Food & Drug Administration. (2021, October 22). FDA Approves XIPERE™ (triamcinolone acetonide) Extended Release Injectable Suspension for Ophthalmic Use. U.S. Food & Drug Administration. [6] U.S. Food & Drug Administration. (n.d.). Orphan Drug Designations and Approvals. Retrieved from [FDA website for drug approval information - actual URL not provided in prompt but would be searched and included here].