Meglumine manufacturers

About tafamidis

Tafamidis manufacturers are currently led by the originator, Pfizer, which sells Vyndamax and Vyndaqel, while generic companies such as Hikma, Cipla and Dexcel have settled to launch US generics from 1 June 2031. Tafamidis is an oral transthyretin stabiliser for transthyretin amyloidosis (ATTR), a disease in which misfolded proteins build up in the heart or nerves. It is one of the world's best-selling medicines, with sales of about USD 6.4 billion in 2025. Pharmaceutical companies can prepare tafamidis capsule and API dossiers for markets where patents allow.

Tafamidis key facts

Tafamidis manufacturers and licensing history

Tafamidis was developed by FoldRx, which Pfizer acquired in 2010. The EU first approved it in 2011 as Vyndaqel for hereditary ATTR polyneuropathy. In May 2019, the FDA approved Vyndaqel and Vyndamax for ATTR cardiomyopathy, which made tafamidis one of Pfizer's largest products. Pfizer reports that the lower-dose Vyndaqel was discontinued at the end of 2025, and tafamidis is now sold mainly as Vyndamax.

From June 2023, several generic companies filed ANDAs challenging tafamidis patents. In March 2026, Pfizer settled the Vyndaqel case, and in April 2026 it settled with Hikma, Cipla and Dexcel. These companies may launch generic Vyndamax on 1 June 2031, subject to other litigation, including an ongoing case with Apotex.

Buyers should confirm the API's solid form, GMP status and freedom to operate before choosing a dossier partner, because the main remaining patent covers a crystalline form.

Tafamidis dosage forms and dossier types

Tafamidis is approved as 61 mg soft capsules (Vyndamax) and 20 mg tafamidis meglumine soft capsules (Vyndaqel).

Tafamidis regulatory and patent status

The EU approved tafamidis in 2011, and the FDA in May 2019 for ATTR cardiomyopathy. In the US, settlements in March and April 2026 allow generic Vyndamax from 1 June 2031, subject to other litigation. The crystalline form patent challenged by generic companies expires on 31 August 2035. Check the FDA Orange Book, litigation status and EU registers before planning a launch.

Tafamidis mechanism of action and therapeutic use

Transthyretin is a blood protein that normally forms a stable four-part structure. In ATTR amyloidosis, it falls apart and misfolds into amyloid fibrils that damage the heart or nerves. Tafamidis binds to transthyretin and stabilises it, slowing amyloid formation. It is taken once daily for ATTR cardiomyopathy to reduce deaths and hospital stays for heart problems.

Tafamidis licensing and sourcing

Tafamidis suppliers and licensing partners typically offer dossier development, API supply or technology transfer, timed for patent expiry. Buyers usually compare GMP status, solid-form strategy, patent position and territory availability. Current offers and supplier contacts are listed among the tafamidis manufacturers on Pipelinepharma.

Frequently asked questions about tafamidis

Who are the main tafamidis manufacturers? Pfizer is the originator and sells Vyndamax and Vyndaqel. Hikma, Cipla and Dexcel have settled with Pfizer to launch US generics from 1 June 2031.

When can generic tafamidis launch in the US? Under April 2026 settlements, generic Vyndamax can launch on 1 June 2031, subject to other litigation, including a pending case with Apotex.

What is the difference between Vyndamax and Vyndaqel? Vyndamax contains 61 mg tafamidis free acid, taken once daily. Vyndaqel contains 20 mg tafamidis meglumine. Pfizer reports that Vyndaqel was discontinued at the end of 2025.

What forms and strengths of tafamidis are available? Tafamidis is available as 61 mg soft capsules (Vyndamax) and 20 mg tafamidis meglumine soft capsules (Vyndaqel).

What is tafamidis used for? Tafamidis is used for transthyretin amyloid cardiomyopathy and, in the EU, for hereditary transthyretin amyloid polyneuropathy.