Last updated: February 20, 2026
Who manufactures LIALDA?
LIALDA, known generically as mesalamine or mesalazine, is marketed primarily under the brand name LIALDA in the United States. The drug is indicated for the treatment of ulcerative colitis.
The originator of LIALDA is Shire Pharmaceuticals, now part of Takeda Pharmaceutical Company. Takeda has exclusive rights to the brand in several regions, including North America.
Who are the authorized suppliers and manufacturers?
Original Manufacturer
- Takeda Pharmaceuticals (formerly Shire)
- Produces LIALDA under Takeda's license.
- Headquarters: Japan.
- Operations include manufacturing facilities in the U.S. and elsewhere to meet regulatory standards.
Generic Manufacturers
Following patent expiry, multiple generic companies have entered the market, producing mesalazine formulations similar to LIALDA. These include:
| Company |
Product Name |
Market Regions |
Approximate Launch Year |
Manufacturing Locations |
Notes |
| Dr. Reddy's Laboratories |
Mesalamine ER |
U.S., various countries |
2016–2018 |
India, U.S., other facilities |
Approved as a generic alternative |
| Mylan (now part of Viatris) |
Mesalamine |
U.S., Europe |
2012–2014 |
India, U.S. |
Widely available for ulcerative colitis |
| Teva Pharmaceuticals |
Mesalamine |
U.S., Europe |
2010–2012 |
Israel, U.S., Europe |
Offers both oral and suppository forms |
| Sun Pharmaceutical |
Mesalamine |
India, U.S., international |
2015–2017 |
India, U.S. |
Marketed as an equivalent generic |
Considerations in the Supply Chain
- Regulatory Approvals: Generics require Food and Drug Administration (FDA) approval in the U.S. and corresponding agencies elsewhere to market mesalamine products as therapeutically equivalent.
- Manufacturing Standards: GMP (Good Manufacturing Practice) compliance is necessary for all approved manufacturing sites.
- Supply Chain Complexity: The market is fragmented, with multiple entities manufacturing and distributing mesalamine formulations worldwide.
Market Dynamics influencing suppliers
- Patent expiration of LIALDA in the U.S. occurred around 2016, facilitating generic entry.
- Limited number of manufacturers with FDA approval reduces supply chain risks.
- Price competition among generics has increased since 2016, affecting manufacturer margins.
- Takeda retains manufacturing rights for the brand-name drug, which maintains a market niche in areas where brand preference persists.
Geographic supply considerations
- North America: Dominated by Takeda, Mylan, Teva, and Sun Pharma.
- Europe: Several European companies hold marketing authorizations, including Almirall and Sandoz.
- Asia: Multiple local manufacturers produce mesalamine generics, often with regional registration.
Summary
LIALDA is produced by Takeda Pharmaceuticals under its original patent. Post-patent expiry, multiple generics from companies such as Dr. Reddy’s, Mylan, Teva, and Sun Pharma supply the market, with manufacturing facilities primarily located in India, the U.S., and Europe. The supply landscape is competitive, with regulatory approval serving as a key barrier for entry.
Key Takeaways
- Takeda (via Shire) is the original manufacturer of LIALDA.
- Generics from Dr. Reddy’s, Mylan, Teva, and Sun Pharma dominate the post-patent market.
- Manufacturing locations are mainly India, U.S., and Europe.
- Regulatory compliance and patent expiry drive current supply dynamics.
- The market remains competitive with multiple approved suppliers.
FAQs
1. Is LIALDA available from multiple suppliers?
Yes. After patent expiration, generic versions are supplied by several manufacturers globally.
2. Who are the top generic manufacturers of mesalamine in the U.S.?
Mylan (Viatris), Teva, and Sun Pharma are among the major generic suppliers.
3. Are there differences in manufacturing standards among suppliers?
All approved manufacturers must comply with GMP standards set by regulatory agencies such as the FDA or EMA.
4. When did the patent for LIALDA expire?
The U.S. patent expired around 2016, allowing generics to enter the market.
5. Does Takeda still produce LIALDA?
Yes. Takeda continues manufacturing and marketing LIALDA in regions where the patent is still in effect or where they hold exclusive rights.
References
- Food and Drug Administration. (2022). Approved Drug Products: Mesalamine products. FDA.gov.
- European Medicines Agency. (2022). Mesalazine. EMA.europa.eu.
- Takeda Pharmaceutical Company. (2023). LIALDA product information.
- U.S. Patent and Trademark Office. (2016). Patent expiry information for LIALDA.
- IQVIA. (2022). Global pharmaceutical market data.
