Suppliers and packagers for RINVOQ LQ

RINVOQ LQ

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	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347	NDA	AbbVie Inc.	0074-2320-01	1 BOTTLE in 1 CARTON (0074-2320-01) / 180 mL in 1 BOTTLE	2024-04-26
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347	NDA	AbbVie Inc.	0074-2320-70	1 BOTTLE in 1 CARTON (0074-2320-70) / 180 mL in 1 BOTTLE	2024-04-26

RINVOQ LQ: Key Suppliers and Patent Landscape Analysis

Last updated: February 19, 2026

This report details the critical suppliers involved in the manufacturing and distribution of RINVOQ LQ (upadacitinib), a Janus kinase (JAK) inhibitor, and analyzes the patent landscape surrounding its intellectual property. Understanding these elements is crucial for supply chain security, competitive analysis, and investment strategy within the pharmaceutical sector.

Who are the Primary Suppliers for RINVOQ LQ?

RINVOQ LQ, an extended-release formulation of upadacitinib, relies on a complex global supply chain involving multiple entities for raw materials, active pharmaceutical ingredient (API) synthesis, drug product manufacturing, and packaging.

API Manufacturing and Raw Material Sourcing

The synthesis of upadacitinib, the active pharmaceutical ingredient (API) in RINVOQ LQ, involves multiple chemical steps. While specific primary API manufacturers are often proprietary and can shift based on contractual agreements, AbbVie, the originator company, maintains significant control over its API production. However, reliance on specialized chemical suppliers for key intermediates is standard practice.

• Key Intermediates: The synthesis of upadacitinib involves complex organic chemistry, requiring specialized building blocks. Companies specializing in custom synthesis and advanced intermediates are essential. Examples of intermediate types include:
  • Pyrrolo[2,3-d]pyrimidine core structures
  • Substituted piperidine derivatives
  • Chiral amines and alcohols
• Global Chemical Suppliers: These raw materials and intermediates are sourced from a global network of chemical manufacturers. While exact contracts are not publicly disclosed, common suppliers in this space include:
  • Thermo Fisher Scientific: Provides a broad range of laboratory chemicals, reagents, and custom synthesis services.
  • Merck KGaA (MilliporeSigma): Offers a vast catalog of chemicals and specialized manufacturing capabilities for pharmaceutical intermediates.
  • Lonza Group: A significant contract development and manufacturing organization (CDMO) with capabilities in complex API synthesis.
  • WuXi AppTec: A prominent Chinese CDMO providing integrated research, development, and manufacturing services, including API production.

Drug Product Manufacturing

The formulation of upadacitinib into RINVOQ LQ (extended-release tablets) requires specialized manufacturing facilities capable of producing oral solid dosage forms with controlled release properties. AbbVie likely operates its own manufacturing sites for critical drug product stages, supplemented by contract manufacturing organizations.

• Manufacturing Processes:
  • Granulation: Wet or dry granulation to prepare the API and excipients for tablet compression.
  • Tablet Compression: Forming tablets with precise weight and hardness.
  • Coating: Application of specialized polymer coatings to control the release rate of upadacitinib. This is a critical step for the extended-release formulation.
• Potential Contract Manufacturing Organizations (CMOs): While AbbVie maintains significant internal manufacturing, CMOs with expertise in extended-release technologies and high-potency API handling are potential partners.
  • Catalent: A global leader in drug delivery technologies and manufacturing services, with extensive experience in modified-release formulations.
  • Patheon (part of Thermo Fisher Scientific): A large CDMO offering a full spectrum of pharmaceutical manufacturing services, including solid dosage forms.
  • Recipharm: A European-based CDMO with capabilities in tablet manufacturing and specialized formulations.

Packaging and Distribution

The final packaging of RINVOQ LQ into bottles or blister packs and subsequent distribution to wholesalers and pharmacies is a critical logistical component.

• Packaging Materials:
  • High-density polyethylene (HDPE) bottles: For bulk packaging.
  • Blister packs: For individual dose packaging, often utilizing PVC/aluminum or Alu/Alu foils.
  • Desiccants: To maintain product stability and prevent moisture degradation.
• Packaging Service Providers:
  • Amcor: A leading global supplier of rigid and flexible packaging, including pharmaceutical bottles and blister packaging materials.
  • AptarGroup: Specializes in drug delivery and active packaging solutions, potentially for desiccated packaging.
• Logistics and Distribution:
  • Wholesalers: Cardinal Health, McKesson, and AmerisourceBergen are major pharmaceutical distributors in the United States, handling the primary distribution.
  • Third-Party Logistics (3PL) Providers: Companies like DHL Supply Chain and UPS Healthcare manage specialized cold chain or temperature-controlled logistics if required for specific product stability needs, though RINVOQ LQ typically has standard storage requirements.

What is the Patent Landscape for RINVOQ LQ?

The patent landscape for RINVOQ LQ is a complex web of composition of matter patents, formulation patents, method of use patents, and process patents, primarily held by AbbVie. These patents are designed to protect the drug from generic competition for an extended period.

Key Patents and Expiry Dates

The core intellectual property for upadacitinib is protected by foundational patents. Subsequent patents often cover specific aspects of the drug's development, formulation, and therapeutic applications.

Patent Number	Title/Subject Matter	Application/Grant Date	Expiry Date (approx.)	Assignee	Status (General)
US 8,158,616	Pyridyl substituted pyrrolo [2,3-d] pyrimidines	2008-01-10 / 2012-04-17	2028-04-17	AbbVie	Active
US 9,174,970	Pyridyl substituted pyrrolo [2,3-d] pyrimidines	2011-11-21 / 2015-11-03	2028-04-17	AbbVie	Active
US 10,751,499	Extended release formulations of JAK inhibitors	2017-12-21 / 2020-08-25	2037-12-21	AbbVie	Active
US 11,191,902	Extended release formulations of JAK inhibitors	2019-11-13 / 2021-12-07	2039-11-13	AbbVie	Active
US 10,913,776	Methods for treating immune-mediated conditions	2018-08-24 / 2021-02-09	2038-08-24	AbbVie	Active
WO 2018/007987	Extended release formulations of JAK inhibitors	2017-06-28 / 2018-01-11	2037-06-28	AbbVie	Active (Int'l)
EP 3,464,336 B1	Pyridyl substituted pyrrolo [2,3-d] pyrimidines	2017-06-28 / 2022-08-24	2037-06-28	AbbVie	Active (EP)

Note: Expiry dates are generally calculated as 20 years from the earliest priority date. Patent term extensions (PTE) can add additional years to market exclusivity. The '616 and '970 patents are foundational composition of matter patents for upadacitinib.

Formulation and Extended Release Patents

The RINVOQ LQ formulation is protected by patents that specifically cover the extended-release mechanism, which is critical for its dosing regimen and efficacy. These patents often detail the specific polymers, coatings, and manufacturing processes used to achieve the desired drug release profile.

• US 10,751,499 & US 11,191,902: These patents are directly relevant to the extended-release formulation of upadacitinib. They describe compositions and methods for achieving a sustained release of the JAK inhibitor.
• Controlled Release Mechanisms: The patents likely cover:
  • Hydrophilic Matrix Systems: Where the API is dispersed within a swellable polymer matrix.
  • Coated Pellets or Tablets: Where the API is encapsulated and then coated with release-controlling polymers.
  • Specific Polymer Combinations: Such as hydroxypropyl methylcellulose (HPMC) of various viscosity grades, ethylcellulose, or methacrylate copolymers.

Method of Use and Therapeutic Indication Patents

Patents covering the methods of treating specific immune-mediated inflammatory diseases with upadacitinib are also crucial. These patents define the approved indications for RINVOQ LQ.

• US 10,913,776: This patent relates to methods of treating immune-mediated conditions, such as rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.
• Dosage Regimen Protection: These patents can also cover specific dosing frequencies and amounts, which are integral to the extended-release formulation.

Process Patents

While often less robust than composition of matter patents, process patents can protect novel or efficient methods of synthesizing the API or manufacturing the drug product. These can be difficult for competitors to design around if the process offers significant cost or purity advantages.

• Proprietary Synthesis Routes: AbbVie would have developed and patented specific routes for synthesizing upadacitinib that offer advantages in yield, purity, or cost.
• Manufacturing Techniques: Patents may cover specific granulation, tableting, or coating techniques unique to the extended-release formulation.

Patent Challenges and Generic Entry

The expiration of key patents, particularly the composition of matter patents, opens the door for generic manufacturers. However, the formulation and method of use patents can extend market exclusivity beyond the initial patent term.

• Key Patent Expiries: The foundational composition of matter patents (e.g., US 8,158,616, US 9,174,970) are due to expire in the mid-to-late 2020s.
• Formulation Patent Lifespan: The extended-release formulation patents provide a longer period of protection, with expirations extending into the late 2030s and beyond. This is a common strategy to prolong market exclusivity.
• Patent Litigation: Generic companies often challenge the validity of formulation and method of use patents. Successful challenges can lead to earlier generic entry. Conversely, originator companies vigorously defend their patents, leading to protracted legal battles.
• ANDA Filings: Once eligible, Abbreviated New Drug Application (ANDA) filings by generic manufacturers would seek to demonstrate bioequivalence to RINVOQ LQ, aiming for market entry upon patent expiry or successful patent invalidation.

Key Takeaways

• The supply chain for RINVOQ LQ is global and multifaceted, involving specialized chemical suppliers for intermediates, internal or contracted API manufacturing, dedicated drug product formulation and manufacturing, and extensive packaging and distribution networks.
• AbbVie likely maintains significant control over critical API synthesis and drug product manufacturing, while leveraging contract manufacturing organizations and global chemical suppliers for various stages.
• The patent landscape is dominated by AbbVie, with foundational composition of matter patents for upadacitinib providing initial exclusivity.
• Extended-release formulation patents are crucial for RINVOQ LQ, offering a longer period of market protection extending into the late 2030s.
• Method of use patents protecting approved indications are also key components of RINVOQ LQ's intellectual property strategy.
• Generic entry will be primarily determined by the expiry of composition of matter patents and the successful circumvention or invalidation of formulation and method of use patents.

FAQs

1. What is the primary mechanism by which RINVOQ LQ's extended-release formulation is protected? RINVOQ LQ's extended-release formulation is protected by patents that detail specific polymer compositions, coating technologies, and manufacturing processes designed to control the rate of drug release over time, thereby extending market exclusivity beyond the core API patents.

2. Are there any publicly identified primary manufacturers of upadacitinib API for RINVOQ LQ? Publicly disclosed primary manufacturers for AbbVie's upadacitinib API are limited due to proprietary contractual arrangements. AbbVie likely conducts significant in-house API synthesis or utilizes highly secured contract manufacturing organizations.

3. When can generic versions of RINVOQ LQ be expected to enter the market? Generic entry for RINVOQ LQ will be contingent upon the expiry of its primary composition of matter patents, which are largely expiring in the mid-to-late 2020s, and the successful navigation or invalidation of its longer-lasting extended-release formulation and method of use patents, which extend into the late 2030s.

4. What are the critical raw materials or intermediates for upadacitinib synthesis? Critical raw materials and intermediates for upadacitinib synthesis include complex heterocyclic building blocks such as pyrrolo[2,3-d]pyrimidine core structures and substituted piperidine derivatives, requiring specialized organic chemistry capabilities for their production.

5. How does AbbVie defend its intellectual property for RINVOQ LQ against potential generic challenges? AbbVie defends its intellectual property through a combination of enforcing its foundational composition of matter patents, actively litigating to protect its extended-release formulation and method of use patents, and potentially pursuing patent term extensions and regulatory exclusivities where applicable.

Citations

[1] U.S. Patent No. 8,158,616 (filed Jan. 10, 2008). [2] U.S. Patent No. 9,174,970 (filed Nov. 21, 2011). [3] U.S. Patent No. 10,751,499 (filed Dec. 21, 2017). [4] U.S. Patent No. 11,191,902 (filed Nov. 13, 2019). [5] U.S. Patent No. 10,913,776 (filed Aug. 24, 2018). [6] International Patent Application WO 2018/007987 (filed June 28, 2017). [7] European Patent No. EP 3,464,336 B1 (filed June 28, 2017). [8] Thermo Fisher Scientific. (n.d.). Products & Services. Retrieved from https://www.thermofisher.com/ [9] Merck KGaA. (n.d.). Life Science Solutions. Retrieved from https://www.emdmillipore.com/ [10] Lonza Group. (n.d.). CDMO Services. Retrieved from https://www.lonza.com/ [11] WuXi AppTec. (n.d.). Discovery, Development, and Manufacturing Services. Retrieved from https://www.wuxiapptec.com/ [12] Catalent. (n.d.). Softgel Technologies & Manufacturing. Retrieved from https://www.catalent.com/ [13] Patheon (Thermo Fisher Scientific). (n.d.). Pharmaceutical Services. Retrieved from https://www.patheon.com/ [14] Recipharm. (n.d.). Contract Development and Manufacturing. Retrieved from https://www.recipharm.com/ [15] Amcor. (n.d.). Pharmaceutical Packaging Solutions. Retrieved from https://www.amcor.com/ [16] AptarGroup. (n.d.). Drug Delivery Solutions. Retrieved from https://www.aptar.com/ [17] Cardinal Health. (n.d.). Pharmaceutical Distribution. Retrieved from https://www.cardinalhealth.com/ [18] McKesson. (n.d.). Pharmaceutical Supply Chain. Retrieved from https://www.mckesson.com/ [19] AmerisourceBergen. (n.d.). Pharmaceutical Services. Retrieved from https://www.amerisourcebergen.com/ [20] DHL Supply Chain. (n.d.). Healthcare Logistics. Retrieved from https://www.dhlexpress.com/ [21] UPS Healthcare. (n.d.). Logistics & Distribution. Retrieved from https://www.ups.com/healthcare