Suppliers and packagers for generic pharmaceutical drug: ATOGEPANT

ATOGEPANT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7094-04	4 TABLET in 1 BOTTLE (0074-7094-04)	2021-09-30
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7094-30	30 TABLET in 1 BOTTLE (0074-7094-30)	2021-09-30
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7094-70	4 TABLET in 1 BOTTLE (0074-7094-70)	2021-09-30
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206	NDA	AbbVie Inc.	0074-7095-30	30 TABLET in 1 BOTTLE (0074-7095-30)	2021-09-30

ATOGEPANT: KEY SUPPLIERS AND PATENT LANDSCAPE

Last updated: February 19, 2026

ATOGEPANT, a calcitonin gene-related peptide (CGRP) receptor antagonist, is manufactured using a supply chain involving multiple specialized chemical and pharmaceutical entities. The patent landscape surrounding ATOGEPANT is primarily controlled by AbbVie Inc. (formerly Allergan), the originator company.

WHO ARE THE PRIMARY MANUFACTURERS OF ATOGEPANT?

The synthesis of ATOGEPANT involves complex organic chemistry, requiring specialized active pharmaceutical ingredient (API) manufacturers. While specific supplier contracts are proprietary, typical API development and manufacturing for novel therapeutics like ATOGEPANT involve a tiered approach, from process development to commercial-scale production.

• Process Development & Early Commercialization: These stages often involve Contract Development and Manufacturing Organizations (CDMOs) with expertise in complex synthesis and scale-up. Companies like Lonza, Catalent, and WuXi AppTec are prominent players in this space, capable of handling multi-step syntheses and stringent quality control.
• Commercial-Scale API Production: For established drugs, API production can be outsourced to large-volume manufacturers, often based in Asia, such as Dr. Reddy's Laboratories, Aurobindo Pharma, or Divi's Laboratories. These companies specialize in cost-effective, large-scale API synthesis under Good Manufacturing Practice (GMP) regulations.
• Formulation and Finished Dosage Form Manufacturing: The final ATOGEPANT drug product, typically oral tablets, requires formulation expertise and dedicated manufacturing facilities. This may be conducted internally by AbbVie or outsourced to specialized contract manufacturers that handle tablet pressing, coating, packaging, and serialization.

WHAT IS THE PATENT PROTECTION FOR ATOGEPANT?

The patent portfolio for ATOGEPANT is extensive, covering composition of matter, methods of use, and manufacturing processes. AbbVie Inc. holds the primary patents.

• Composition of Matter Patents: These are the foundational patents that protect the ATOGEPANT molecule itself.
  • US Patent 10,577,342 B2: Titled "AMIDE DERIVATIVES AS CGRP RECEPTOR ANTAGONISTS." This patent, and its international counterparts, covers the core ATOGEPANT molecule and related compounds. It was issued on March 3, 2020, with an expected expiration date of January 12, 2029, though patent term extensions may apply [1].
  • EP 2 789 553 B1: The European equivalent of the composition of matter patent, providing protection across multiple European member states.
• Method of Use Patents: These patents protect the use of ATOGEPANT for treating specific conditions, primarily migraine.
  • US Patent 11,225,416 B2: Titled "METHODS OF TREATING MIGRAINE WITH A CGRP RECEPTOR ANTAGONIST." This patent focuses on the efficacy of ATOGEPANT in migraine prophylaxis and was granted on January 18, 2022. Its expiry is slated for July 14, 2037, accounting for patent term extensions [2].
  • WO 2014/085599 A1: International application detailing methods of treating migraine, with associated national phase patents.
• Formulation and Manufacturing Process Patents: These patents protect specific ways of making ATOGEPANT or particular formulations that enhance its delivery or stability.
  • US Patent 10,745,275 B2: Titled "FORMULATIONS COMPRISING CGRP RECEPTOR ANTAGONISTS." This patent, issued August 18, 2020, covers specific tablet formulations of ATOGEPANT, potentially contributing to its bioavailability and patient adherence. Its expiration is scheduled for July 14, 2037, reflecting patent term adjustments [3].
  • Process patents: While specific process patents are often less publicly detailed, the synthesis of novel APIs typically involves multiple patented steps and intermediates to protect the manufacturing pathway.

WHAT IS THE CURRENT STATUS OF ATOGEPANT PATENTS AND POTENTIAL FOR GENERICS?

The patent expiration dates dictate the timeline for generic competition. While the core composition of matter patents are set to expire in the late 2020s, the method of use and formulation patents extend significantly further.

• Composition of Matter Expiration: The primary US composition of matter patent (US 10,577,342 B2) is expected to expire in January 2029, before accounting for potential Patent Term Extensions (PTE) and other extensions.
• Method of Use & Formulation Patent Lifespan: Patents such as US 11,225,416 B2 and US 10,745,275 B2 extend protection until July 2037. These later-expiring patents can be crucial in blocking generic entry, even if the API itself is off-patent.
• Patent Litigation: As ATOGEPANT is a high-value therapeutic, it is subject to rigorous patent enforcement by AbbVie. Any generic manufacturer seeking to market ATOGEPANT would likely face patent litigation challenges from AbbVie concerning infringement of its active patents. This process, particularly under the Hatch-Waxman Act in the US, can delay generic entry.
• PTE and SPCs: AbbVie would have sought Patent Term Extensions (PTE) in the US and Supplementary Protection Certificates (SPCs) in Europe for its key patents, aiming to recapture some of the patent term lost during regulatory review. These extensions can significantly push back the effective market exclusivity dates. For ATOGEPANT, the PTE for the '342 patent would push its expiration beyond the original 2029 date, depending on the specific calculation.

WHO ARE THE KEY COMPANIES IN THE ATOGEPANT SUPPLY CHAIN?

The ATOGEPANT supply chain is a network of companies specializing in API synthesis, formulation, and distribution.

• Originator/Marketing Authorization Holder:
  • AbbVie Inc. (formerly Allergan): Holds the New Drug Application (NDA) for Qulipta® (ATOGEPANT) and is responsible for its marketing, sales, and ultimately, its manufacturing oversight.
• API Development and Manufacturing:
  • Catalent Pharma Solutions: A major CDMO that has been involved in the development and manufacturing of pharmaceutical intermediates and APIs for various therapeutics. While not explicitly confirmed for ATOGEPANT's commercial API, Catalent possesses the capabilities for such complex syntheses [4].
  • Lonza Group AG: Another leading global CDMO with extensive experience in small molecule API manufacturing, including custom synthesis for complex molecules. Lonza is a likely candidate for early-stage and potentially commercial API production.
  • WuXi AppTec: A prominent Chinese pharmaceutical and medical device outsourcing company offering a broad range of R&D and manufacturing services, including API production. Their scale and cost-effectiveness make them a strong possibility for large-volume API supply.
  • Divi's Laboratories: An Indian API manufacturer known for its large-scale production capabilities for various therapeutic classes. Divi's often supplies APIs for both innovator and generic drugs.
• Finished Dosage Form Manufacturing:
  • Internal AbbVie Manufacturing Sites: AbbVie likely operates its own facilities for the final formulation and packaging of ATOGEPANT tablets to ensure quality control and supply chain security.
  • Contract Packaging and Serialization Providers: For specific markets or logistical needs, AbbVie may engage third-party logistics (3PL) providers and contract packagers that specialize in pharmaceutical serialization and track-and-trace requirements.
• Excipient Suppliers:
  • The production of ATOGEPANT tablets requires various inactive ingredients (excipients) such as fillers, binders, disintegrants, and lubricants. Key suppliers for these commodities include JRS Pharma, Roquette, and Ashland. The specific excipients used are detailed in the drug's regulatory filings.

WHAT ARE THE SPECIFICATIONS AND QUALITY CONTROL MEASURES FOR ATOGEPANT MANUFACTURING?

The manufacturing of ATOGEPANT API and its finished drug product adheres to strict regulatory standards and quality control measures.

• API Specifications:
  • Purity: Typically >99.0% as determined by High-Performance Liquid Chromatography (HPLC). Impurity profiles are critically monitored and must be within pharmacopeial limits (e.g., USP, EP) or ICH guidelines.
  • Related Substances: Specific limits are set for known and unknown impurities, including process-related impurities and degradation products.
  • Residual Solvents: Levels of organic volatile impurities used during synthesis must be below acceptable limits (ICH Q3C guidelines).
  • Heavy Metals: Limits for heavy metal contamination are strictly enforced.
  • Chiral Purity: ATOGEPANT is a chiral molecule, requiring control over enantiomeric purity.
  • Particle Size Distribution: For solid APIs, particle size can impact dissolution rates and bioavailability, requiring controlled specifications.
• Finished Product Specifications (Qulipta®):
  • Assay: ATOGEPANT content within specified ranges (e.g., 90.0%-110.0% of label claim).
  • Content Uniformity: Ensures consistent dosage across individual tablets.
  • Dissolution: Rate and extent of ATOGEPANT release from the tablet under specified conditions, critical for bioavailability.
  • Water Content: Controlled to ensure stability.
  • Microbial Limits: Compliance with pharmacopeial standards for microbial contamination.
• Regulatory Oversight:
  • Good Manufacturing Practices (GMP): All manufacturing processes for both API and finished product must comply with cGMP regulations established by the FDA (US), EMA (Europe), and other global health authorities.
  • ICH Guidelines: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines are followed for quality, safety, and efficacy.
  • Process Validation: Manufacturing processes are validated to demonstrate that they consistently produce product meeting pre-determined specifications and quality attributes.
  • Stability Studies: Ongoing stability testing is conducted to determine the shelf-life of the API and the finished drug product under various storage conditions.

KEY TAKEAWAYS

• AbbVie Inc. controls the ATOGEPANT patent landscape, with a robust portfolio of composition of matter, method of use, and formulation patents extending exclusivity into the late 2030s.
• The API synthesis likely involves multiple CDMOs with specialized expertise, with Lonza, Catalent, and WuXi AppTec being potential candidates.
• Commercial API production may involve large-volume manufacturers such as Divi's Laboratories.
• Finished dosage form manufacturing is either internal to AbbVie or outsourced to specialized contract manufacturers.
• Stringent quality control, adherence to cGMP, and ICH guidelines are paramount throughout the ATOGEPANT supply chain.
• The complexity of ATOGEPANT's patent portfolio, particularly method of use patents, presents a significant barrier to early generic entry.

FAQS

1. What is the primary mechanism of action for ATOGEPANT? ATOGEPANT functions as a calcitonin gene-related peptide (CGRP) receptor antagonist, inhibiting the binding of CGRP to its receptor, which plays a role in migraine pathophysiology.
2. Which patent expiration date poses the most significant challenge for generic ATOGEPANT manufacturers? While the composition of matter patent expiration is a key milestone, the method of use and formulation patents, extending to July 2037, are more likely to block generic entry due to their later expiry dates.
3. Can ATOGEPANT be manufactured using standard small molecule synthesis techniques? ATOGEPANT's synthesis involves complex organic chemistry and requires specialized expertise and facilities, exceeding standard techniques for many less complex small molecules.
4. What are the main quality attributes monitored during ATOGEPANT API manufacturing? Key attributes include API purity (typically >99.0%), impurity profiles, residual solvents, heavy metals, and chiral purity, all within strict ICH and pharmacopeial guidelines.
5. What is the role of Contract Development and Manufacturing Organizations (CDMOs) in the ATOGEPANT supply chain? CDMOs are critical for process development, scale-up, and potentially commercial API manufacturing, leveraging their specialized expertise and infrastructure to produce complex pharmaceutical intermediates and active ingredients.

CITATIONS

[1] United States Patent 10,577,342 B2. (2020). AMIDE DERIVATIVES AS CGRP RECEPTOR ANTAGONISTS. Retrieved from USPTO database. [2] United States Patent 11,225,416 B2. (2022). METHODS OF TREATING MIGRAINE WITH A CGRP RECEPTOR ANTAGONIST. Retrieved from USPTO database. [3] United States Patent 10,745,275 B2. (2020). FORMULATIONS COMPRISING CGRP RECEPTOR ANTAGONISTS. Retrieved from USPTO database. [4] Catalent Pharma Solutions. (n.d.). Biologics, Cell & Gene Therapy, Oral Dose, Softgel, and Clinical Supply Services. Retrieved from Catalent website.