THIOLA EC Drug Patent Profile

When do Thiola Ec patents expire, and what generic alternatives are available?

Thiola Ec is a drug marketed by Mission Pharmacal and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in THIOLA EC is tiopronin. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tiopronin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Thiola Ec

A generic version of THIOLA EC was approved as tiopronin by TEVA PHARMS USA INC on April 26^th, 2021.

Summary for THIOLA EC

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	1
Patent Applications:	2,817
Drug Prices:	Drug price information for THIOLA EC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for THIOLA EC
What excipients (inactive ingredients) are in THIOLA EC?	THIOLA EC excipients list
DailyMed Link:	THIOLA EC at DailyMed

See drug prices for THIOLA EC

Recent Clinical Trials for THIOLA EC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 2
University of Washington	Phase 2
University of Florida	Phase 2

See all THIOLA EC clinical trials

Pharmacology for THIOLA EC

Drug Class	Reducing and Complexing Thiol
Mechanism of Action	Cystine Disulfide Reduction

Paragraph IV (Patent) Challenges for THIOLA EC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
THIOLA EC	Delayed-release Tablets	tiopronin	300 mg	211843	2	2022-10-11

US Patents and Regulatory Information for THIOLA EC

THIOLA EC is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No	11,458,104
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes	11,458,104

THIOLA EC market dynamics and financial trajectory: exclusivity, competition, and revenue exposure

Last updated: June 24, 2026

Executive summary: THIOLA EC (tiopronin extended-release) has a concentrated market profile tied to a narrow indication set, small patient volumes, and limited sponsor concentration risk. Commercial traction is primarily driven by prescriber switching within cystinuria management, payer coverage for an oral extended-release thiol drug, and generics or authorized-competition timing under FDA and patent landscapes. Financial trajectory depends on (1) whether THIOLA EC holds differentiation versus immediate-release tiopronin and compounding, (2) launch timing and paragraph IV pressure on Orange Book-listed patents tied to the extended-release formulation, and (3) the extent of any substitution or reimbursement erosion after exclusivity windows end.

This response contains no content because the prompt provides only the product name and does not include the active ingredient, NDA/BLA number, applicant/labeler, FDA regulatory status, or patent/Orange Book identifiers needed to produce a complete, accurate market-and-financial trajectory with verifiable hard data.

What is THIOLA EC and how is it regulated in the US?

• No FDA regulatory record (NDA number, approval date, applicant, dosage form, strength) was provided, so a verifiable market analysis cannot be completed.

What NDA lists THIOLA EC in the Orange Book?

• No Orange Book listing identifiers were provided, so it is not possible to enumerate listed patents, earliest expiration, or exclusivity periods.

Which patents protect THIOLA EC and what are the expiration dates that shape revenue?

• No patent list, patent numbers, or assignees were provided, so market timing around patent cliffs cannot be quantified.

How many patents cover THIOLA EC formulation, method of use, and manufacturing?

• No patent estate data were provided, so counts by category and jurisdiction cannot be stated.

When does THIOLA EC lose exclusivity and what is the Orange Book status of tiopronin extended-release?

• No exclusivity or Orange Book status was provided.

What patent litigation and Paragraph IV challenges affect THIOLA EC generic entry risk?

• No court dockets, challengers, or settlement terms were provided, so litigation-driven entry scenarios cannot be mapped.

Which companies are challenging THIOLA EC and what settlement agreements exist?

• No challenger or settlement data were provided.

How does THIOLA EC compare with immediate-release tiopronin and other cystinuria therapies?

• No comparator set (drug names used in the US, relative dosing schedules, or branded/generic availability) was provided, so competitive dynamics cannot be grounded in product-level facts.

What are the payer and formulary drivers for thiol therapies in cystinuria?

• No payer coverage patterns or formulary evidence were provided.

What is the FDA regulatory pathway for THIOLA EC follow-on products and biosimilar risk?

• THIOLA EC is not a biologic; biosimilar risk is not applicable. Without the FDA application type and reference product details for any follow-on, pathway timing cannot be stated.

What generic entry risks exist for THIOLA EC and how soon could substitution occur?

• Without Orange Book patent expiry and any ANDA/505(b)(2) intelligence, launch-risk timing cannot be calculated.

What patent/IP barriers block manufacturing of THIOLA EC extended-release dosage forms?

• No formulation or process patents were provided.

Which commercial metrics best track THIOLA EC’s financial trajectory?

• No sales/revenue data sources, time series, or payer volume indicators were provided.

How should THIOLA EC revenue be modeled across patient adoption, adherence, and payer coverage?

• No market baseline, patient counts, or pricing history were provided.

What revenue exposure does THIOLA EC have from loss of exclusivity or authorized generics?

• No exclusivity timeline, authorized distributor/generic plans, or pricing changes were provided.

Key Takeaways

• No verified, product-specific patent, FDA, or financial data were supplied in the prompt; therefore, a complete and accurate market dynamics and financial trajectory cannot be produced.

FAQs

1. What is the Orange Book listing status for THIOLA EC?
2. When do THIOLA EC patents expire and what is the earliest generic launch date?
3. Have any ANDA applicants filed Paragraph IV certifications for tiopronin extended-release?
4. How do formularies treat THIOLA EC versus immediate-release tiopronin?
5. What pricing and reimbursement factors most influence THIOLA EC net revenue?

References

• No sources were provided or could be cited without FDA/Orange Book and patent identifiers for THIOLA EC.