TIROSINT Drug Patent Profile

When do Tirosint patents expire, and when can generic versions of Tirosint launch?

Tirosint is a drug marketed by Ibsa and is included in two NDAs. There are four patents protecting this drug and five Paragraph IV challenges.

This drug has three patent family members in three countries.

The generic ingredient in TIROSINT is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tirosint

A generic version of TIROSINT was approved as levothyroxine sodium by MYLAN on June 5^th, 2002.

Summary for TIROSINT

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	2,577
Drug Prices:	Drug price information for TIROSINT
Drug Sales Revenues:	Drug sales revenues for TIROSINT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIROSINT
What excipients (inactive ingredients) are in TIROSINT?	TIROSINT excipients list
DailyMed Link:	TIROSINT at DailyMed

See drug prices for TIROSINT

See drug sales revenues for TIROSINT

Recent Clinical Trials for TIROSINT

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

Sponsor	Phase
Cromsource	Phase 4
University of California, Los Angeles	Phase 4
Children's Mercy Hospital Kansas City	Phase 4

See all TIROSINT clinical trials

Pharmacology for TIROSINT

Drug Class

l-Thyroxine

Paragraph IV (Patent) Challenges for TIROSINT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIROSINT	Capsules	levothyroxine sodium	137 mcg and 175 mcg	021924	1	2022-11-04
TIROSINT	Capsules	levothyroxine sodium	200 mcg	021924	1	2021-12-30
TIROSINT	Capsules	levothyroxine sodium	112 mcg	021924	1	2020-12-18
TIROSINT	Capsules	levothyroxine sodium	88 mcg, 100 mcg and 125 mcg	021924	1	2019-08-01
TIROSINT	Capsules	levothyroxine sodium	75 mcg and 150 mcg	021924	1	2017-12-29

US Patents and Regulatory Information for TIROSINT

TIROSINT is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-015	Jan 13, 2021		RX	Yes	No
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-012	Dec 15, 2016		RX	Yes	Yes
Ibsa	TIROSINT-SOL	levothyroxine sodium	SOLUTION;ORAL	206977-004	Dec 15, 2016		RX	Yes	No			Y

Expired US Patents for TIROSINT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-008	Oct 2, 2009
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-005	Oct 13, 2006
Ibsa	TIROSINT	levothyroxine sodium	CAPSULE;ORAL	021924-003	Oct 13, 2006

International Patents for TIROSINT

See the table below for patents covering TIROSINT around the world.

Country	Patent Number	Title	Estimated Expiration
China	121909021
Italy	202300020130
World Intellectual Property Organization (WIPO)	2025068935

Supplementary Protection Certificates for TIROSINT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1291021	132012902104794	Italy		PRODUCT NAME: LEVOTIROXINA SODICA(ALIASINT); AUTHORISATION NUMBER(S) AND DATE(S): RVG 106848; 106850-106860, 20110407;DA 041528011/M A 041528365/M, 20120808

Last updated: July 29, 2026

TIROSINT market dynamics and financial trajectory: US demand trends, payer pressure, competition, and exclusivity risks

TIROSINT (levothyroxine sodium) sits in a mature, highly scrutinized thyroid-replacement market where brand pricing power depends on (1) guideline-driven need for consistent bioavailability, (2) formulary access versus generic substitution, and (3) manufacturing and product-formulation perceptions (liquid vs tablet pathways). Financial trajectory in the US is primarily a function of prescription volume stability, margin structure after rebates, and exposure to generic/authorized generics and any formulation switching.

How is TIROSINT performing commercially in the US (sales, prescriptions, growth rate)?

What matters for TIROSINT’s financial trajectory:

• Prescription volume stability within chronic hypothyroidism management, where patients persist if symptom control and TSH targets remain stable.
• Formulary placement and net-price outcomes driven by pharmacy benefit manager (PBM) rebate intensity and state substitution rules.
• Share-of-voice pressure from levothyroxine tablets and liquid generics/authorized generics that reduce brand differentiation.
• Switching friction: clinicians often resist frequent switching when patients are stable, but payers can counter with step edits and substitution mandates.

Market structure impacts:

• Levothyroxine is a high-volume endocrine therapy with intense generic penetration. Branded products typically face steady erosion as multiple generics capture the majority of prescriptions over time.
• TIROSINT competes on the narrative of predictable absorption and reduced variability versus some tablet regimens, which can translate into payer justification when medically necessary criteria are met.

Bottom-line business dynamic:

• TIROSINT’s sales path tends to track net pricing durability and patient retention more than category growth. Category volume grows slowly because hypothyroidism prevalence changes gradually; the main swings come from share and reimbursement.

What patents protect TIROSINT and how strong is the patent estate for exclusivity?

TIROSINT is a formulation of levothyroxine sodium delivered as a softgel capsule (commonly described as liquid-filled). The legal exclusivity profile determines whether TIROSINT can defend against generic “same active, same dosage form” entrants and whether competitors are free to enter based on approval routes that do not require branded exclusivity.

Patent estate typically controls:

• Formulation protection (composition, excipients, capsule construction, and manufacturing methods)
• Method-of-use protection is often less central for levothyroxine because the indication space is established and generic challengers can often target formulation carve-outs.

Key business read-through:

• In thyroid hormone replacement, exclusivity tends to be narrower than for novel drugs. When formulation patents expire or are found non-infringing, competitive pressure accelerates and net sales compress.

Litigation and entry timing sensitivity:

• Even when approvals occur for generics, actual financial impact is delayed by pharmacy channel behavior and prescriber switching patterns, then accelerates when larger PBMs move to preferred generics.

When does TIROSINT lose exclusivity and what is the Orange Book status of TIROSINT?

For a complete Orange Book status assessment, the exact NDA number, Orange Book listing(s), listed patents (including method and formulation), and the expiration dates must be mapped to each NDA supplement and listed claim. A reliable exclusivity timeline also depends on regulatory exclusivity blocks (for example, 5-year New Chemical Entity status does not apply to levothyroxine) and any pediatric exclusivity or patent term adjustments.

Because the prompt does not provide the Orange Book listing table (NDA number and listed patents), a definitive date-by-date exclusivity timeline cannot be produced in a way that is actionable for litigation, licensing, or investment decisions.

How many generic or authorized generic competitors threaten TIROSINT and what generic entry risks exist?

In levothyroxine, generic entry risk is structurally high:

• Multiple abbreviated new drug applications (ANDAs) can use established active ingredient references once formulation and patent barriers are cleared.
• If patents protecting the specific TIROSINT presentation expire, competitors can often compete on price quickly through PBM contracting.

Generic entry risk profile for investors and licensors:

• Higher probability of erosion than for differentiated small molecules.
• Timing depends on patent milestones rather than clinical differentiation.

Financial risk translation:

• When a generic becomes preferred on formularies, brand net sales often drop quickly, not because efficacy changes, but because rebate economics and pharmacy substitution shift the channel.

What patent litigation affects TIROSINT and how do Paragraph IV challenges impact market share?

For TIROSINT, the impact of Paragraph IV litigation would be determined by:

• Whether challengers filed ANDA certifications to specific listed Orange Book patents, and
• The outcome (dismissal, settlement, or adverse judgment), including any authorized generic or delayed entry arrangements.

A litigation timeline with specific case numbers, district courts, settlement dates, and stipulation terms cannot be reconstructed from the information provided in the prompt. Without named litigants and asserted patents, a reliable “what litigation affects TIROSINT” section would be incomplete.

Which companies are challenging TIROSINT and what are their launch strategies?

Competitive threats in levothyroxine formulations are usually executed through:

• ANDA filings targeting the same dosage form or a close bioequivalent alternative,
• Authorized generic strategy via settlements,
• PBM contracting using lower acquisition cost and rebate leverage.

A company-by-company challenge map requires confirmed ANDA filer names, patent numbers asserted, and approval/launch status. Those details are not provided in the prompt, so a precise list cannot be produced without risking inaccuracies.

How does TIROSINT compare with other levothyroxine products (tablets and liquids) on reimbursement and switching behavior?

Formulation and switching:

• Patients and prescribers frequently perceive higher absorption consistency with liquid/softgel platforms versus some tablet regimens.
• Switching can change measured TSH and symptom stability. This creates a “medical necessity” friction point that can support brand retention if payers allow override for stable patients.

Payer reimbursement mechanics:

• When a brand is non-preferred, net price declines and patient access depends on prior authorization.
• In preferred tiers, the brand can hold a larger share if PBM rebates offset the generic price differential.

Competitive comparison (business lens):

• Tablets: broader generic penetration, lower cost base, higher switching frequency.
• Liquid/softgel: fewer direct equivalents historically, better patient retention narrative, but still vulnerable once generics consolidate formulary positioning.

What formulations are protected for TIROSINT and what manufacturing/IP barriers matter?

In levothyroxine softgel or liquid formulations, key protective layers typically include:

• Capsule fill formulation (levothyroxine solvent system and excipients)
• Capsule shell composition and sealing
• Manufacturing process controls that affect stability and dissolution
• Storage and handling conditions tied to product stability

Why this matters financially:

• Even when bioequivalence looks achievable on paper, manufacturing variability can drive regulatory scrutiny (CMC) and can deter fast competitive replication if the process is difficult to replicate without risk.

A definitive list of TIROSINT-specific protected components requires patent number-level mapping to the formulation.

What is the FDA regulatory pathway for TIROSINT, and what does that mean for future generics/biosimilar entry?

Levothyroxine products are small-molecule drugs, so the biosimilar framework does not apply. Regulatory pathways for competing products would be:

• ANDAs under an appropriate reference-listed drug,
• Potential 505(b)(2) for certain formulation changes, depending on how much is proprietary vs referenced.

Regulatory-to-market translation:

• Once formulation and patent barriers fall, FDA approvals can convert into rapid price competition.
• For mature APIs, the main pacing is legal rather than regulatory.

A precise description of TIROSINT’s NDA-to-approval pathway and any supplements requires the NDA number and supplement history.

What is the revenue exposure to TIROSINT erosion under different generic launch scenarios?

Scenario framework used in financial diligence for mature brands:

• Base case: steady volume, gradual share loss as formularies prefer generics.
• Accelerated erosion: brand moves out of preferred status or multiple generics obtain preferred contracts simultaneously.
• Stabilized share: brand retains medical necessity carve-outs and patient stability support with strong prior authorization processes.

Key KPI drivers:

• Net price per script (after rebates)
• TRx and share in therapy
• Contracting outcomes (PBM preferencing and step edits)
• Percent of patients with stable dose therapy and low switching

Without baseline sales and time series data in the prompt, the analysis cannot be quantified with revenue numbers.

Key Takeaways

• TIROSINT’s financial trajectory is dominated by generic substitution economics and formulary positioning, not by category growth.
• Brand protection depends on whether formulation-specific patents and exclusivity delay generic entry and whether payers accept medical necessity for stable patients.
• Market dynamics in levothyroxine are structurally hostile to sustained branded pricing, so net sales durability hinges on contract leverage and patient switching friction.
• A complete exclusivity and litigation risk map requires Orange Book patent listing identifiers and confirmed litigation details.

FAQs

1. Does TIROSINT have FDA exclusivity that delays generic entry?
2. What PBM contracting dynamics most often determine TIROSINT net pricing?
3. How do prior authorization rules affect TIROSINT prescription retention versus generics?
4. What CMC or formulation constraints can slow down levothyroxine softgel generic entry?
5. How does TIROSINT switching risk influence prescriber behavior and payer step-edit strategies?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.

DrugChatter Q&A for TIROSINT

When will tirosint be available in brazil?
Why is tirosint so expensive?
How much does tirosint cost?
Why is tirosint not covered by insurance?
Tirosint inactive ingredients?