Suppliers and packagers for thiola

thiola

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharma	THIOLA	tiopronin	TABLET;ORAL	019569	NDA	Mission Pharmacal Company	0178-0900-01	100 TABLET, SUGAR COATED in 1 BOTTLE (0178-0900-01)	1988-08-11

THIOLA (tiopronin): Who supplies it and what’s the sourcing/IP landscape?

Last updated: June 2, 2026

Executive summary: THIOLA is supplied as tiopronin. The active ingredient supply chain is typically organized around generic API manufacturers and finished-dose contract manufacturers, while the regulatory and IP positioning is governed by FDA Orange Book listings and any method-of-use or formulation patents tied to tiopronin products. The specific “supplier” roster depends on which specific THIOLA NDA labeler and manufacturer-to-distributor chain is used in the U.S. market, plus current FDA listings for the marketed dosage form(s).

Who are the suppliers for THIOLA (tiopronin) in the U.S. market?

Featured snippet: THIOLA suppliers map to (1) the FDA-registered NDA labeler/holder for the marketed tiopronin product and (2) the contract manufacturers and API plants used under that labeler’s supply chain. Supplier identification requires checking FDA’s Orange Book for the NDA labeler and the listed dosage form(s), then matching that labeler to current commercial packaging and distributor records.

What companies are listed as the NDA labeler and manufacturer for THIOLA?

Orange Book entry structure typically lists:

• Applicant/Holder (NDA sponsor)
• Manufacturing site(s) for the drug product
• Dosage form strengths tied to the NDA

What is usually the API sourcing model for tiopronin used in THIOLA?

Most tiopronin markets follow one of these patterns:

• Single API source under a long-term supply agreement tied to the labeler
• Multi-supplier API strategy with approved interchangeability under GMP and specification controls

What patents protect THIOLA (tiopronin) and who owns the IP?

Featured snippet: Patent coverage for THIOLA is determined by Orange Book-listed patents under the relevant NDA and any listed exclusivities. Patent ownership can include the NDA holder and assignees of formulation, process, or method-of-use claims.

How many patents cover THIOLA and how long do they last?

Orange Book records list each patent with:

• Patent number
• Expiry date
• Patent type (composition, method of use, formulation, manufacturing process)
• Patent scope by listed claims

Are formulation or manufacturing patents present for THIOLA?

For legacy small-molecule products like tiopronin, patent estates commonly include at least one of:

• Formulation (film coat, excipient system, dissolution profile)
• Manufacturing process (granulation, crystallization, polymorph control)
• Method-of-use (indication-specific regimen)

When does THIOLA (tiopronin) lose exclusivity and what does that do to supplier risk?

Featured snippet: Exclusivity loss timing is driven by the latest of:

• Patent expiry (listed in Orange Book)
• Regulatory exclusivities (if applicable) tied to the NDA
• Any pediatric exclusivity extensions

What are the key exclusivity drivers for legacy small-molecule drugs?

Typical drivers:

• NDA approval exclusivity windows that end before most patent estates fully expire
• Patent “last to expire” that controls paragraph IV attractiveness

Do exclusivity events change supplier qualification timelines?

Yes. Even when exclusivity ends, GMP supply adoption depends on:

• Contract packaging lead times
• Finished-goods stability and shelf-life
• API qualification and change-control approvals

What is the Orange Book status of THIOLA (tiopronin)?

Featured snippet: Orange Book status is the authoritative index for:

• NDA number
• Dosage form listed
• Approved applicant/holder
• Patent listings and exclusivity periods

What dosage forms and strengths are listed for THIOLA?

Orange Book lists each strength and dosage form under the NDA. Supplier assessment must follow the exact strength, because manufacturing sites and tech transfer can differ across strengths.

Is THIOLA tied to any single-source manufacturing site?

If Orange Book manufacturing site listings show narrow site coverage, it implies higher supply concentration risk.

Are there paragraph IV challenges for THIOLA (tiopronin) and which companies are targeting it?

Featured snippet: Paragraph IV filings are identified through FDA’s public submissions and litigation records. The existence and frequency of such challenges indicates how attractive THIOLA’s patent estate is.

What does paragraph IV activity imply for future suppliers?

• Frequent challenges suggest lower remaining enforceable patent barriers
• Settlement outcomes often control launch timing and can allocate commercial supply through agreements

What THIOLA generic entry risks exist (ANDA, exclusivity, and patent barriers)?

Featured snippet: Generic entry risk is dominated by:

• The “last patent to expire” listed for the NDA
• Whether any patents are still in force and litigated
• Any regulatory exclusivities blocking AB-rated substitution

What manufacturing/IP barriers can block ANDA supply?

• Process patents that cover critical manufacturing steps
• Formulation patents tied to controlled-release or dissolution targets (if claimed)
• Method-of-use claims that require labeling carve-outs

How does THIOLA (tiopronin) supplier performance compare with other tiopronin brands/generics?

Featured snippet: Comparative supplier performance depends on:

• Number of qualified manufacturers
• Backup API supply
• Regulatory flexibility under changes

Which factors influence whether a generic can scale supply quickly?

• Bulk API availability and polymorph control
• Finished-goods batch consistency
• Packaging constraints and line clearances

What FDA regulatory status and labeling constraints affect THIOLA sourcing?

Featured snippet: FDA-approved labeling determines whether substitution requires any REMS-like constraints (rare for tiopronin) or specific instructions that affect commercial onboarding.

Does THIOLA have any special distribution or handling requirements?

Handling requirements are typically product-specific but generally follow standard GMP distribution controls for small-molecule oral drugs.

What THIOLA patent litigation affects supplier and contract manufacturing decisions?

Featured snippet: Litigation affects supply because:

• Parties may restrict launch or manufacturing to avoid induced infringement
• Court-ordered stays can delay market entry even after NDA approval

How do settlements typically reallocate market access?

Settlement terms often cover:

• Effective launch dates
• Carve-outs for certain dosage forms or strengths
• License scopes and royalty structures
• Manufacturing and labeling commitments

Commercial impact: how much revenue is exposed to generic supplier substitution?

Featured snippet: Revenue exposure depends on:

• Current U.S. prescriptions and market share by labeler
• Whether payors have switched to AB-rated equivalents
• Any ongoing shortages that protect price

What metrics determine exposure for the next 24 months?

• Number of ANDA/generic players
• Pharmacy adoption and formulary placement
• Any supply constraints tied to the API or formulation

Key Takeaways

• “Suppliers for THIOLA” in practice means the FDA-registered NDA labeler plus the GMP-manufacturing and API supply chain supporting the specific marketed strengths/dosage forms.
• Orange Book listings define what can be supplied and by whom because they identify patents and exclusivities that constrain generic entry.
• Paragraph IV and litigation drive launch timing and can temporarily lock in supply under the existing labeler’s manufacturing network.
• Supplier risk is concentration-driven: the fewer qualified sites and API sources tied to the NDA, the higher the disruption risk if a site goes offline.

FAQs

1. How do I identify the correct NDA labeler for THIOLA (tiopronin) dosage forms?
2. What patent types (composition, method-of-use, manufacturing) most often block ANDA supply for tiopronin products?
3. When a THIOLA patent expires, can generics immediately supply the same strength, or do stability and site changes delay launch?
4. Do THIOLA generics face labeling carve-outs tied to method-of-use patents, and how does that affect substitution?
5. How does API polymorph or crystallization control affect supplier qualification for tiopronin?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-02).
2. FDA. Drug Approval Reports and associated regulatory information for tiopronin (THIOLA). (Accessed 2026-06-02).