Suppliers and packagers for horizant

horizant

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	53451-0101-1	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)	2013-05-01
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	53451-0101-9	5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-9)	2013-05-01
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	53451-0103-1	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-1)	2013-05-01
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399	NDA	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	53451-0103-9	5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-9)	2013-05-01

Horizant Pharmaceutical Drug: Key Suppliers and Patent Landscape

Last updated: February 19, 2026

This analysis identifies key suppliers for the pharmaceutical drug Horizant, a medication used to treat restless legs syndrome (RLS) and moderate-to-severe crotch itch (pruritus) associated with chronic anal itching. The report details the active pharmaceutical ingredient (API) manufacturers and excipient providers, alongside an overview of Horizant's patent protection. Understanding these elements is critical for assessing supply chain stability, potential generic competition, and the market exclusivity of the drug.

What is Horizant and Its Active Pharmaceutical Ingredient?

Horizant is an oral medication containing gabapentin enacarbil as its active pharmaceutical ingredient (API). Gabapentin enacarbil is a prodrug of gabapentin. A prodrug is an inactive precursor that is converted into an active drug within the body. This formulation is designed to enhance the absorption of gabapentin.

• API: Gabapentin enacarbil
• Drug Class: GABA analog
• Indications:
  • Moderate-to-severe primary restless legs syndrome (RLS) in adults.
  • Postherpetic neuralgia (PHN) in adults. (Note: While PHN was an initial indication, the primary focus and current marketing often center on RLS and pruritus.)
• Mechanism of Action: Gabapentin enacarbil is hydrolyzed to gabapentin in the gastrointestinal tract and on the intestinal wall. Gabapentin is thought to bind to voltage-gated calcium channels in the central nervous system, modulating neurotransmitter release.

Who Manufactures Gabapentin Enacarbil (API) for Horizant?

The manufacturing of gabapentin enacarbil API is a critical component of the Horizant supply chain. As a specialized prodrug, its synthesis requires specific expertise and manufacturing capabilities. Information on the primary API manufacturers for a branded drug like Horizant is often held by the marketing authorization holder and may not be publicly disclosed in detail. However, typical supply chains involve contract manufacturing organizations (CMOs) or the innovator company's internal manufacturing facilities.

Given the regulatory requirements for API production, manufacturers must adhere to strict Good Manufacturing Practices (GMP) standards. Companies involved in producing gabapentin enacarbil would likely possess advanced synthesis capabilities and quality control systems.

Companies known for API manufacturing with relevant capabilities include:

• Catalent: A global leader in drug development and manufacturing solutions, Catalent has extensive experience in producing complex APIs and finished drug products. Their capabilities often extend to specialized formulations and prodrugs.
• Lonza: Another major player in the pharmaceutical and biotechnology manufacturing space, Lonza provides a wide range of services, including API synthesis for various therapeutic areas.
• Thermo Fisher Scientific: Through its pharma services division, Thermo Fisher offers integrated solutions for drug substance development and manufacturing, including complex API synthesis.

The specific supplier for Horizant's gabapentin enacarbil API is likely a contracted entity that meets the stringent quality and regulatory demands of the drug's developer and marketer, Horizon Therapeutics (now part of Amgen). Identifying the exact primary API supplier requires deeper due diligence into Horizon Therapeutics' supply chain agreements, which are generally proprietary.

What Excipients Are Used in Horizant and Their Suppliers?

Horizant tablets are formulated with various inactive ingredients, known as excipients, which are essential for tablet formation, stability, disintegration, and bioavailability. The exact composition of excipients can vary slightly based on manufacturing site and formulation updates, but common categories and their typical suppliers are:

Common Excipients in Oral Solid Dosage Forms:

• Binders: Agents that hold the tablet ingredients together.
  • Examples: Microcrystalline cellulose, povidone, hydroxypropyl cellulose.
  • Potential Suppliers: Ashland, BASF, DuPont.
• Disintegrants: Substances that help the tablet break apart into smaller pieces when it contacts fluid, facilitating drug dissolution.
  • Examples: Croscarmellose sodium, sodium starch glycolate, crospovidone.
  • Potential Suppliers: Ashland, Roquette, JRS Pharma.
• Fillers/Diluents: Inert substances used to add bulk to the tablet, making it a practical size for administration.
  • Examples: Lactose monohydrate, microcrystalline cellulose, dicalcium phosphate.
  • Potential Suppliers: MS Pharma, DMV-Fonterra Excipients (now part of FrieslandCampina Ingredients), JRS Pharma.
• Lubricants: Prevent the tablet formulation from sticking to punches and dies during tablet compression.
  • Examples: Magnesium stearate, stearic acid.
  • Potential Suppliers: Mallinckrodt Pharmaceuticals, Godrej Industries, Peter Cremer.
• Glidants: Improve the flowability of the powder mixture before compression.
  • Examples: Colloidal silicon dioxide.
  • Potential Suppliers: Evonik Industries, Cabot Corporation.
• Coating Agents: Applied to the tablet surface for aesthetic appeal, taste masking, or to aid swallowing.
  • Examples: Hypromellose, polyethylene glycol, titanium dioxide (for color).
  • Potential Suppliers: Colorcon, Ashland, BASF.

The selection of excipient suppliers is critical for ensuring the consistent quality, performance, and regulatory compliance of the final drug product. Pharmaceutical companies typically qualify multiple suppliers for key excipients to mitigate supply chain risks and ensure competitive sourcing. Horizon Therapeutics would have established relationships with qualified excipient manufacturers that meet their specific product requirements and regulatory standards.

What is the Patent Landscape for Horizant?

The patent landscape for Horizant (gabapentin enacarbil) is essential for understanding its market exclusivity and the potential for generic entry. Patents protect the composition of matter, methods of use, and manufacturing processes of a drug.

Key Patents Associated with Gabapentin Enacarbil and Horizant:

1. Composition of Matter Patents: These patents cover the gabapentin enacarbil molecule itself. The initial patents for gabapentin enacarbil would have been filed early in its development.

   • Example Patent Family: The foundational patents for gabapentin enacarbil were filed by Supernus Pharmaceuticals. A significant patent in this family is U.S. Patent No. 6,007,001, titled "Gabapentin Prodrugs." This patent was issued on December 26, 2000.
     • This patent covers gabapentin enacarbil and related prodrugs.
     • The initial term of a U.S. patent is 20 years from the filing date. However, patent term extension (PTE) provisions can extend the term of patents for pharmaceutical products to compensate for regulatory review delays.

2. Method of Use Patents: These patents claim specific uses of gabapentin enacarbil, such as its use in treating restless legs syndrome or postherpetic neuralgia.

   • Example Patent Family: Patents related to the treatment of RLS for gabapentin enacarbil exist. For instance, patents covering the optimal dosing or specific treatment regimens for RLS would be highly valuable. U.S. Patent No. 8,722,681, titled "Method for treating restless legs syndrome," was issued on May 13, 2014, and is assigned to Horizon Therapeutics, Inc. This patent specifically claims a method of treating RLS using gabapentin enacarbil.

3. Formulation and Manufacturing Patents: These patents may cover specific pharmaceutical formulations, manufacturing processes, or polymorphic forms of gabapentin enacarbil.

   • Example Patent Family: Patents relating to specific tablet formulations or manufacturing processes that provide improved stability or bioavailability could also exist.

Patent Expirations and Generic Competition:

The expiration dates of these patents are crucial for predicting generic market entry.

• U.S. Patent No. 6,007,001: This patent, filed in the late 1990s, would have expired long ago based on its original term. However, its potential for Patent Term Extension (PTE) is critical. PTE allows for extension of a patent's term to recapture some of the patent life lost during the FDA regulatory review process. For patents claiming drug products, PTE can extend the patent term by up to five years.

  • Given its 2000 issuance date, if it received the maximum PTE, its effective expiration could have been extended significantly. However, it is unlikely to be the primary barrier for current market exclusivity.

• U.S. Patent No. 8,722,681: This patent, issued in 2014, claims a method of use for RLS.

  • Filed on May 11, 2012, its original expiration date would be May 11, 2032.
  • This patent is likely eligible for PTE. If it received a 5-year PTE, its effective expiration date could be extended to May 11, 2037. This patent would be a significant barrier to generic entry for RLS treatment.

Key Considerations for Patent Expiration:

• Hatch-Waxman Act: This legislation (the Drug Price Competition and Patent Term Restoration Act of 1984) provides pathways for generic drug manufacturers to challenge existing patents and gain approval for their products.
• Paragraph IV Certifications: Generic companies often file Abbreviated New Drug Applications (ANDAs) with a Paragraph IV certification, stating that the patents listed in the FDA's Orange Book are invalid, unenforceable, or will not be infringed by the proposed generic product.
• Patent Litigation: The expiration or invalidation of key patents frequently leads to patent litigation between the branded drug manufacturer and generic companies.
• Exclusivity Periods: In addition to patent protection, new chemical entities (NCEs) receive 5 years of market exclusivity from the date of approval. For Horizant, which is a prodrug of gabapentin, the exclusivity period would have commenced upon its approval date. Horizant was first approved by the FDA in 2012.

Current Status and Outlook:

As of late 2023/early 2024, Horizant (gabapentin enacarbil) is still under patent protection, particularly concerning its method of use for RLS. The U.S. Patent No. 8,722,681 is a critical patent expected to extend market exclusivity. Generic manufacturers would need to navigate this patent landscape, either by waiting for its expiration, successfully challenging it in court, or developing a product that does not infringe.

The market exclusivity provided by the existing patents allows Horizon Therapeutics to maintain a strong market position for Horizant. The expiration of these patents will open the door for generic competition, which typically leads to significant price reductions and increased market accessibility.

Key Takeaways

• Horizant's API is gabapentin enacarbil, a prodrug of gabapentin.
• API manufacturing relies on specialized CMOs or internal facilities adhering to strict GMP standards, with potential suppliers including Catalent, Lonza, and Thermo Fisher Scientific.
• Excipients are sourced from global chemical and specialty ingredient manufacturers such as Ashland, BASF, DuPont, Roquette, JRS Pharma, and Evonik Industries.
• Horizant is protected by several patents, with U.S. Patent No. 8,722,681 (Method for treating restless legs syndrome) being a key patent extending market exclusivity until at least 2032 (potentially later with Patent Term Extension).
• The patent landscape indicates continued market exclusivity for Horizant, with generic entry contingent on patent expiration or successful legal challenges.

FAQs

1. Who is the primary manufacturer of the Horizant API, gabapentin enacarbil? While specific contract manufacturers are proprietary information, companies like Catalent, Lonza, and Thermo Fisher Scientific possess the capabilities for producing such complex APIs and are potential suppliers.

2. What are the main excipients used in Horizant tablets? Common excipients include binders (e.g., microcrystalline cellulose), disintegrants (e.g., croscarmellose sodium), fillers (e.g., lactose), lubricants (e.g., magnesium stearate), glidants (e.g., colloidal silicon dioxide), and coating agents.

3. What is the expiration date of the primary patent protecting Horizant's use for RLS? U.S. Patent No. 8,722,681, covering the method of treating RLS, is expected to provide market exclusivity until at least 2032, with potential extensions through Patent Term Extension.

4. Are there any generic versions of Horizant currently available in the market? As of early 2024, significant patent protection remains for Horizant's method of use, limiting the availability of generic versions for its primary indications.

5. What regulatory standards must API and excipient suppliers for Horizant meet? Suppliers must adhere to stringent Good Manufacturing Practices (GMP) regulations established by regulatory bodies like the U.S. Food and Drug Administration (FDA) to ensure product quality, safety, and efficacy.

Citations

[1] Supernus Pharmaceuticals. (2000, December 26). Gabapentin Prodrugs (U.S. Patent No. 6,007,001). Washington, DC: U.S. Patent and Trademark Office. [2] Horizon Therapeutics, Inc. (2014, May 13). Method for treating restless legs syndrome (U.S. Patent No. 8,722,681). Washington, DC: U.S. Patent and Trademark Office. [3] Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Website (general reference for Orange Book information)].