Last updated: June 13, 2026
THIOLA EC drug suppliers: Who manufactures Thiola EC (tiopronin extended-release) and what are the sourcing risks?
Thiola EC is an extended-release formulation of tiopronin (active ingredient: tiopronin). It is marketed in the US and sourced through brand and authorized manufacturing supply chains tied to the listed FDA marketing authorization and label manufacturing information.
Who are the manufacturers and suppliers of THIOLA EC (tiopronin ER) in the US?
Featured snippet answer: THIOLA EC is supplied by the company holding the US marketing authorization and using labeled finished-product manufacturing sites listed in FDA labeling and Orange Book records for tiopronin extended-release.
What to look for on the label and Orange Book
For “supplier” decisions, the relevant parties are:
- Marketing authorization holder / labeler (responsible for the product in the FDA system)
- Finished dose manufacturer(s) listed on the US label
- Active pharmaceutical ingredient (API) supplier chain behind tiopronin (often via internal or contracted API vendors; rarely disclosed publicly)
- Contract manufacturing organizations (CMOs) named in FDA inspections, label manufacturing sections, or supplier qualification disclosures (limited public detail)
Regulatory record linkage (what defines the real supplier set)
- FDA Orange Book listing identifies the US NDA holder/labeler and associated patent/exclusivity records (when applicable).
- US prescribing information identifies manufacturing sites for the drug product (finished dosage form).
- NDC labeling helps map which firm supplies each strength and package configuration.
Because the exact Orange Book entry, NDA number, labeler, NDCs, and labeled manufacturing sites for THIOLA EC are not provided in the prompt, a complete and accurate supplier roster cannot be produced.
What patents protect THIOLA EC and how does that constrain alternative suppliers?
Featured snippet answer: Patent and exclusivity protections constrain entry by preventing generic or follow-on manufacturing for the same formulation unless a Paragraph IV challenge and successful litigation occur, or exclusivity has expired.
How formulation and method patents impact supply
For extended-release products like THIOLA EC, the constrained supplier set usually reflects:
- Formulation and release-profile patents (protecting ER technology)
- Manufacturing method patents
- Use patents (if any) tied to tiopronin indications
- Compound patents and process patents for tiopronin (where still active)
If you do not have the Orange Book patent numbers for the specific THIOLA EC listing, the constrained supplier map cannot be enumerated accurately.
When does THIOLA EC lose exclusivity and when can generic suppliers enter?
Featured snippet answer: Generic supplier timelines depend on the specific THIOLA EC patent expiration dates and any applicable FDA exclusivity (including pediatric or other exclusivity) attached to the relevant NDA/ANDA listing.
What defines generic entry timing
- Patent expiry dates in the Orange Book for the listed NDA
- Any exclusivity periods (5-year, 3-year, pediatric extensions, etc.)
- Litigation settlement terms that may delay launch
Without the specific Orange Book listing and exclusivity codes/dates, launch windows cannot be stated.
What generic and biosimilar entry risks exist for tiopronin ER like THIOLA EC?
Featured snippet answer: THIOLA EC has a generic-entry risk profile driven by whether there is an approved ANDA with bioequivalence to the ER formulation, and whether patents remain listed for the formulation.
Why supplier risk is formulation-specific
Extended-release products can require:
- matching dissolution profiles
- compatible release excipients
- validated process controls
These are the practical barriers that determine whether additional suppliers can qualify.
What is the Orange Book status of THIOLA EC (tiopronin extended-release)?
Featured snippet answer: The Orange Book status consists of:
- NDA listing presence
- Patent list with expiration dates
- Any exclusivity associated with the NDA
No public details are supplied in the prompt, so the Orange Book status cannot be enumerated without introducing inaccuracies.
Which companies are the likely alternative suppliers if THIOLA EC faces shortages?
Featured snippet answer: In shortage scenarios, alternative supply typically comes from:
- additional labeled manufacturing sites
- authorized distributors
- temporarily available batches from the NDA holder’s other production sites
- imports when permitted
A precise list of “alternative suppliers” requires the NDA/labeler manufacturing site data and NDC-level supply chain for THIOLA EC, which are not included.
How many manufacturing sites supply THIOLA EC, and what are the primary production locations?
Featured snippet answer: The number of manufacturing sites and their locations are defined by:
- US label manufacturing sections
- NDC directory ties to specific labelers/manufacturers
These data are not present in the prompt, so a quantified site roster cannot be produced.
What manufacturing/IP barriers limit new suppliers for THIOLA EC?
Featured snippet answer: For an ER drug product, new suppliers face:
- patent-protected formulation or process constraints
- ER performance requirements (dissolution and PK bioequivalence)
- validated GMP manufacturing capacity for ER dosage forms
A barrier-to-market assessment requires the exact patent estate for the THIOLA EC formulation.
Key Takeaways
- “Supplier” for THIOLA EC should be defined by FDA labeler/marketing authorization holder and label-listed finished-product manufacturing sites tied to the specific US listing.
- Patent and exclusivity status determine whether new generic supply can legally enter the market.
- The prompt does not include the Orange Book listing identifiers (NDA/ANDA, patent numbers), NDCs, or label manufacturing sites, so a complete, accurate supplier list cannot be stated without risking errors.
FAQs
- How do I identify the correct finished-product manufacturer for THIOLA EC by NDC?
- Do Orange Book patents for tiopronin ER typically cover formulation or also manufacturing methods?
- What is the fastest legal pathway for a generic supplier to launch after exclusivity expires for THIOLA EC?
- When a shortage occurs, can an NDA holder use alternative sites without FDA approval?
- What submission type is typically required to change ER manufacturing for tiopronin products (changes requiring PAS supplements)?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA database).
- U.S. Prescribing Information and label manufacturing sections for THIOLA EC (tiopronin extended-release). (If sourced from FDA label PDFs or drug labeling repositories).
