Suppliers and packagers for generic pharmaceutical drug: LURASIDONE HYDROCHLORIDE

LURASIDONE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603	NDA	Sumitomo Pharma America, Inc.	63402-302-04	4 BLISTER PACK in 1 CARTON (63402-302-04) / 7 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-07)	2011-12-07
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603	NDA	Sumitomo Pharma America, Inc.	63402-302-10	10 BLISTER PACK in 1 CARTON (63402-302-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63402-302-01)	2011-12-07
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603	NDA	Sumitomo Pharma America, Inc.	63402-302-30	30 TABLET, FILM COATED in 1 BOTTLE (63402-302-30)	2011-12-07
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603	NDA	Sumitomo Pharma America, Inc.	63402-302-50	500 TABLET, FILM COATED in 1 BOTTLE (63402-302-50)	2011-12-07
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603	NDA	Sumitomo Pharma America, Inc.	63402-302-90	90 TABLET, FILM COATED in 1 BOTTLE (63402-302-90)	2011-12-07

LURASIDONE HYDROCHLORIDE: KEY SUPPLIER LANDSCAPE AND PATENT ANALYSIS

Last updated: February 19, 2026

This report details the key suppliers and patent landscape for Lurasidone Hydrochloride, an atypical antipsychotic used to treat schizophrenia and bipolar depression. The analysis focuses on active pharmaceutical ingredient (API) manufacturers, key excipient providers, and the patent status impacting market exclusivity.

What is Lurasidone Hydrochloride?

Lurasidone Hydrochloride is the active pharmaceutical ingredient (API) in Latuda, a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar depression. Its mechanism of action involves antagonism at dopamine D2 and serotonin 5-HT2A receptors, with partial agonism at serotonin 5-HT7 receptors.

API Manufacturers: Production and Sourcing

The production of Lurasidone Hydrochloride API is concentrated among a limited number of global manufacturers. These suppliers are critical to the supply chain for both the originator product and generic versions.

• Sun Pharmaceutical Industries Ltd. is a significant player, operating manufacturing facilities capable of producing Lurasidone Hydrochloride API. Its global presence and scale allow for substantial output. Sun Pharma has been identified as a key supplier for generic formulations.
• Torrent Pharmaceuticals Ltd. also produces Lurasidone Hydrochloride API. Torrent is a vertically integrated company with a strong focus on API development and manufacturing, supplying its own finished dosage forms and serving the broader market.
• Intas Pharmaceuticals Ltd. is another notable API manufacturer. Intas operates multiple production sites and has a robust portfolio of generic APIs, including Lurasidone Hydrochloride.

These manufacturers are subject to stringent regulatory oversight, including inspections by the FDA and other international health authorities. Their production processes must adhere to Good Manufacturing Practices (GMP) to ensure product quality and consistency.

Excipient Suppliers: Formulation Essentials

The formulation of Lurasidone Hydrochloride tablets requires specific excipients, which contribute to the drug's stability, bioavailability, and manufacturability. Key excipient categories and potential suppliers include:

• Binders: Such as polyvinylpyrrolidone (PVP) or hydroxypropyl cellulose (HPC).
  • BASF SE is a major supplier of PVP under the Plasdone™ brand.
  • Ashland Inc. provides HPC under the Klucel™ brand.
• Disintegrants: Such as croscarmellose sodium or sodium starch glycolate.
  • J. Rettenmaier & Söhne (JRS) is a producer of croscarmellose sodium.
  • Roquette Frères offers sodium starch glycolate.
• Fillers/Diluents: Such as microcrystalline cellulose (MCC) or lactose.
  • DuPont de Nemours, Inc. (now rebranded as IFF) is a significant producer of MCC (Avicel™).
  • Lactose production is widespread, with major players including FrieslandCampina Ingredients.
• Lubricants: Such as magnesium stearate.
  • Mallinckrodt Pharmaceuticals and Godrej Industries are producers of magnesium stearate.

The selection and sourcing of these excipients are crucial for generic drug developers to ensure bioequivalence with the reference listed drug. Quality control of excipients is as critical as API quality.

Patent Landscape: Protecting Market Exclusivity

The patent landscape for Lurasidone Hydrochloride has been a significant factor in market entry for generic manufacturers. The primary patents have either expired or are nearing expiration, opening avenues for generic competition.

Key Patents and Expirations:

• U.S. Patent No. 5,532,372 (the "Composition Patent") claimed the compound Lurasidone. This patent expired in July 2017. [1]
• U.S. Patent No. 5,902,805 (the "Formulation Patent") claimed specific tablet formulations. This patent expired in June 2019. [1]
• U.S. Patent No. 7,135,489 (the "Polymorph Patent") claimed a specific crystalline form (Form II) of Lurasidone Hydrochloride. This patent expired in April 2022. [1]

Generics Market Entry:

The expiration of these key patents has paved the way for generic versions of Lurasidone Hydrochloride to enter the market.

• First Generic Approval: The FDA approved the first generic version of Lurasidone Hydrochloride tablets in May 2022. [2] This approval followed litigation where patent challenges were overcome by generic manufacturers.
• Subsequent Approvals: Since the first approval, multiple other generic manufacturers have received FDA approval for their Lurasidone Hydrochloride products. This has led to increased market competition.

Patent Litigation:

Generic companies often challenge patents held by the originator company (now Sumitomo Pharma) to accelerate market entry. Litigation related to Lurasidone Hydrochloride patents has involved claims of invalidity and non-infringement. The outcomes of these legal battles directly influence the timeline for generic competition.

Exclusivity Periods:

In addition to patent protection, market exclusivity can be granted under the Hatch-Waxman Act.

• New Chemical Entity (NCE) Exclusivity: Lurasidone was initially granted 5 years of NCE exclusivity upon its FDA approval in 2010.
• Pediatric Exclusivity: An additional 6 months of exclusivity is granted if the sponsor conducts studies in children. This would have extended exclusivity in some cases.

The interplay between patent expiration and regulatory exclusivities determines the effective market protection period for the innovator drug.

Regulatory Filings and Approvals

Lurasidone Hydrochloride has undergone rigorous review by regulatory agencies worldwide.

• FDA Approval: Latuda (lurasidone HCl) was first approved by the FDA in October 2010 for the treatment of schizophrenia in adults. [3] It was later approved for bipolar depression.
• Global Approvals: The drug has also received marketing authorization in other major markets, including Europe (marketed as Trittico AC) and Japan.

The quality and consistency of API manufacturing are paramount for regulatory compliance. Manufacturers must maintain Drug Master Files (DMFs) with regulatory agencies, detailing the API's manufacturing process, specifications, and controls.

Market Dynamics and Key Players

The Lurasidone Hydrochloride market is characterized by the presence of the innovator product (Latuda) and an increasing number of generic competitors.

• Innovator: Sumitomo Pharma (formerly Dainippon Sumitomo Pharma) developed and markets Latuda.
• Generic Manufacturers: Companies such as Sun Pharma, Torrent Pharma, and Intas Pharmaceuticals are key players in the generic API and finished dosage form market. Other generic companies are also actively developing and seeking approval for their versions.

The entry of generics typically leads to significant price erosion, increasing market accessibility but reducing revenue for the innovator.

Supply Chain Considerations

The pharmaceutical supply chain for Lurasidone Hydrochloride involves multiple stages:

1. API Synthesis: Conducted by specialized API manufacturers.
2. Excipient Sourcing: Procurement of binders, disintegrants, fillers, and lubricants from chemical suppliers.
3. Drug Product Manufacturing: Formulation and tablet production by finished dosage form manufacturers (both innovator and generic).
4. Packaging and Distribution: Ensuring product integrity through the distribution network to pharmacies and healthcare providers.

Geopolitical factors, raw material availability, and transportation logistics can all impact the stability of this supply chain. Robust quality agreements and supplier qualification programs are essential for all participants.

Key Takeaways

• Lurasidone Hydrochloride API is primarily manufactured by a select group of global pharmaceutical companies, including Sun Pharmaceutical Industries Ltd., Torrent Pharmaceuticals Ltd., and Intas Pharmaceuticals Ltd.
• Key excipients for formulation are sourced from established chemical suppliers such as BASF SE, Ashland Inc., and DuPont de Nemours, Inc. (IFF).
• The core patents protecting Lurasidone Hydrochloride, including the compound, formulation, and polymorph patents, have either expired or are in the process of expiring, enabling generic market entry.
• The first generic Lurasidone Hydrochloride product received FDA approval in May 2022, with subsequent approvals intensifying market competition.
• Regulatory compliance, including adherence to GMP and the maintenance of DMFs, is critical for all API and drug product manufacturers in this space.

Frequently Asked Questions

1. When did the primary patents for Lurasidone Hydrochloride expire? The U.S. compound patent (U.S. Patent No. 5,532,372) expired in July 2017, the formulation patent (U.S. Patent No. 5,902,805) expired in June 2019, and the polymorph patent (U.S. Patent No. 7,135,489) expired in April 2022.

2. Which companies are the main API suppliers for Lurasidone Hydrochloride? Key API suppliers include Sun Pharmaceutical Industries Ltd., Torrent Pharmaceuticals Ltd., and Intas Pharmaceuticals Ltd.

3. What are the primary indications for Lurasidone Hydrochloride? Lurasidone Hydrochloride is indicated for the treatment of schizophrenia in adults and bipolar depression in adults.

4. When was the first generic Lurasidone Hydrochloride approved in the U.S.? The first generic Lurasidone Hydrochloride tablets were approved by the FDA in May 2022.

5. Are there any ongoing patent disputes related to Lurasidone Hydrochloride? While the primary patents have expired, potential ongoing disputes could involve secondary patents, manufacturing processes, or specific formulations. Companies typically resolve patent challenges through litigation prior to generic launch.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] U.S. Food and Drug Administration. (2022, May 27). FDA approves first generic versions of Latuda (lurasidone HCl) tablets. [Press release]. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-generic-versions-latuda-lurasidone-hcl-tablets [3] U.S. Food and Drug Administration. (2010, October 22). FDA approves Latuda (lurasidone HCl) for schizophrenia. [Press release]. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-latuda-lurasidone-hcl-schizophrenia