THYRO-TABS Drug Patent Profile

Which patents cover Thyro-tabs, and what generic alternatives are available?

Thyro-tabs is a drug marketed by Alvogen and is included in one NDA.

The generic ingredient in THYRO-TABS is levothyroxine sodium. There is one drug master file entry 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 Thyro-tabs

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

Summary for THYRO-TABS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	2,577
DailyMed Link:	THYRO-TABS at DailyMed

Pharmacology for THYRO-TABS

Drug Class

l-Thyroxine

US Patents and Regulatory Information for THYRO-TABS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	THYRO-TABS	levothyroxine sodium	TABLET;ORAL	021116-001	Oct 24, 2002	AB1,AB2,AB3,AB4	RX	Yes	No
Alvogen	THYRO-TABS	levothyroxine sodium	TABLET;ORAL	021116-005	Oct 24, 2002	AB1,AB2,AB3,AB4	RX	Yes	No
Alvogen	THYRO-TABS	levothyroxine sodium	TABLET;ORAL	021116-010	Oct 24, 2002	AB1,AB2,AB3,AB4	RX	Yes	No
Alvogen	THYRO-TABS	levothyroxine sodium	TABLET;ORAL	021116-009	Oct 24, 2002	AB1,AB2,AB3,AB4	RX	Yes	No
Alvogen	THYRO-TABS	levothyroxine sodium	TABLET;ORAL	021116-012	Dec 7, 2004	AB1,AB2,AB3,AB4	RX	Yes	No

Last updated: August 16, 2026

THYRO-TABS is a U.S. levothyroxine sodium tablet product competing in a mature, price-sensitive thyroid replacement market. Its commercial position depends more on manufacturing reliability, pharmacy-channel access, formulary placement and supply continuity than on patent exclusivity. Public filings do not disclose standalone THYRO-TABS revenue, profit or market share, so the product’s financial trajectory must be assessed through its generic-market position and labeler economics rather than reported brand-level sales.

THYRO-TABS Market Dynamics, Financial Trajectory and Patent Outlook

What is THYRO-TABS and who markets it?

THYRO-TABS is levothyroxine sodium, a synthetic form of thyroxine used for thyroid hormone replacement in hypothyroidism and for thyroid-stimulating hormone suppression in selected thyroid cancer settings. The product is sold in multiple tablet strengths and is associated in U.S. labeling with Lannett Company, Inc. [1]

Levothyroxine is a high-volume, mature prescription medicine. It is available through:

• Generic levothyroxine products
• Branded or authorized-generic products
• Synthroid, marketed by AbbVie
• Levoxyl, associated with Pfizer
• Unithroid, marketed by Amneal Pharmaceuticals
• Euthyrox, marketed by Merck in certain markets

THYRO-TABS competes primarily as a generic or branded-generic product. Its market value is therefore determined by prescription volume, reimbursement rates, wholesale acquisition economics, manufacturing cost and distributor access. It does not have the pricing power normally associated with a novel drug protected by composition-of-matter patents.

THYRO-TABS product profile

Attribute	THYRO-TABS position
Active ingredient	Levothyroxine sodium
Therapeutic category	Thyroid hormone replacement
Dosage form	Oral tablet
U.S. market	Prescription pharmaceutical
Product type	Generic or branded-generic levothyroxine
Main competitors	Synthroid, Levoxyl, Unithroid, Euthyrox and numerous generic suppliers
Primary commercial risk	Price compression and supply disruption
Primary technical risk	Potency consistency and bioequivalence
Standalone revenue disclosure	Not publicly reported

How large is the levothyroxine market?

Levothyroxine is one of the largest chronic-use prescription drug categories in the United States. Demand is supported by the prevalence of hypothyroidism, long-term treatment duration and routine laboratory monitoring. Most patients require continued therapy for years or decades.

The market has several characteristics that shape THYRO-TABS economics:

1. Demand is relatively stable because treatment is chronic.
2. Volume is high, but unit prices are generally low.
3. Pharmacies and payers can substitute among therapeutically equivalent products.
4. Small differences in reimbursement and supply reliability can shift dispensing volume.
5. Patients and prescribers sometimes resist product switching because levothyroxine has a narrow therapeutic index and dose changes can affect thyroid-stimulating hormone control.

The American Thyroid Association has recommended consistent use of a particular levothyroxine formulation where clinically appropriate, with thyroid-stimulating hormone monitoring after a product change. [2] This creates some retention value for established products, but it does not eliminate generic substitution.

Demand drivers

The principal demand drivers are:

• Rising diagnosis of hypothyroidism
• Aging populations
• Long-term treatment after thyroid surgery or radioactive iodine therapy
• Continued use in thyroid cancer management
• Routine prescribing through retail pharmacies
• Increased generic penetration in public and commercial formularies

The principal market constraints are low prices, limited differentiation and intense competition among suppliers.

What is the financial trajectory of THYRO-TABS?

THYRO-TABS does not have a publicly reported standalone financial profile. Lannett’s public filings report company-level or portfolio-level sales rather than product-level revenue for THYRO-TABS. [3] As a result, there is no verified public series for the product’s annual revenue, gross margin, prescription count or operating profit.

The most supportable financial assessment is qualitative:

Financial variable	Likely direction
Prescription demand	Stable to modestly growing
Net price	Downward pressure from generic competition
Gross margin	Sensitive to manufacturing and procurement costs
Revenue	Dependent on retained volume and contract access
Profitability	Vulnerable to price erosion and fixed-cost absorption
Capital requirements	Focused on compliance, quality systems and supply continuity
Cash-flow risk	Higher when production interruptions or customer concentration occur

THYRO-TABS can generate recurring revenue because levothyroxine is a chronic-use medicine. The product’s ceiling is limited by the generic pricing model. Revenue growth is more likely to come from volume retention, additional contracts or supply shortages affecting competitors than from price increases.

Lannett’s financial exposure

Lannett has historically operated as a generic pharmaceutical company with multiple products. Company filings do not identify THYRO-TABS as a separately reported operating segment. The product’s financial contribution therefore cannot be isolated from other generic medicines.

For valuation or transaction analysis, THYRO-TABS should be treated as a portfolio asset with:

• Recurring prescription demand
• Low brand differentiation
• Potentially meaningful pharmacy and wholesaler relationships
• Limited patent value
• Material dependence on manufacturing compliance
• Exposure to generic price deflation

Product-level revenue claims without company disclosure or prescription-data support should not be used in a financial model.

What patents protect THYRO-TABS?

The core levothyroxine molecule is not protected by an active composition-of-matter patent. Levothyroxine has been used clinically for decades, and the market is supplied by multiple generic manufacturers.

THYRO-TABS is therefore unlikely to have a meaningful blocking patent estate covering the active ingredient. Any relevant intellectual-property rights would more likely concern:

• Tablet formulation
• Excipients
• Manufacturing controls
• Packaging
• Stability
• Dosage uniformity
• Product-specific analytical methods

These rights would not normally prevent competing manufacturers from selling levothyroxine tablets if they use non-infringing formulations and satisfy FDA requirements.

Patent estate assessment

Patent category	Commercial relevance to THYRO-TABS
Active ingredient patent	None expected to provide market exclusivity
Basic therapeutic-use patent	Expired or commercially unavailable as a barrier
Formulation patent	Potentially relevant but unlikely to block all generic competition
Manufacturing patent	Possible process protection, generally avoidable through alternative processes
Packaging patent	Limited market impact
Method-of-use patent	Unlikely to control routine hypothyroidism treatment
Trade secret	Potential relevance for process controls and quality systems
Regulatory exclusivity	No evident new-drug exclusivity position

When does THYRO-TABS lose exclusivity?

THYRO-TABS does not appear to rely on an active period of new-drug exclusivity or a current composition-of-matter patent. Its commercial position is already exposed to generic competition.

The relevant exclusivity framework is therefore different from that for a newly approved branded medicine:

• No expected remaining five-year new chemical entity exclusivity
• No expected three-year clinical-investigation exclusivity
• No expected six-month pediatric exclusivity
• No expected orphan-drug exclusivity
• No expected reference-product exclusivity comparable to a novel branded drug
• No apparent blocking patent that controls the levothyroxine market

The practical “loss of exclusivity” occurred when multiple manufacturers entered the levothyroxine market. THYRO-TABS competes within that established generic market rather than approaching a future patent cliff.

What is the Orange Book status of THYRO-TABS?

The FDA Orange Book primarily identifies approved drug products, therapeutic equivalence ratings, patents and exclusivity for products approved under new-drug applications and related pathways. Generic levothyroxine products approved under abbreviated new drug applications may appear through FDA approval and therapeutic-equivalence records, but they do not generally receive Orange Book patent protection comparable to a novel branded product. [4]

For THYRO-TABS, the commercially relevant FDA questions are:

• Whether the specific strength and dosage form remain approved
• Whether the product has an AB-rated equivalent
• Whether the product is listed as active in FDA databases
• Whether there are manufacturing or supply notices
• Whether recalls or regulatory actions affect availability

The product’s competitive position is not primarily determined by Orange Book patent listings.

Are there Paragraph IV challenges involving THYRO-TABS?

A Paragraph IV challenge is unlikely to be commercially central to THYRO-TABS because the product is itself a generic or branded-generic levothyroxine product rather than a patent-protected reference drug.

Paragraph IV litigation in the levothyroxine category would generally concern:

• A new formulation
• A novel delivery system
• A branded product with listed patents
• An ANDA applicant challenging a reference-product patent

No major, product-defining Paragraph IV litigation is identified here as a current driver of THYRO-TABS value. Any litigation involving a formulation or supplier would need to be distinguished from litigation over the core levothyroxine market.

What formulations are protected by THYRO-TABS?

THYRO-TABS is an immediate-release oral tablet. Its differentiation is limited compared with products using liquid, soft-gel or other delivery formats.

The formulation’s technical requirements are demanding even though the underlying chemistry is old. Levothyroxine products require control of:

• Active-ingredient potency
• Content uniformity
• Dissolution
• Stability
• Degradation products
• Tablet-to-tablet dose consistency
• Interaction with excipients
• Packaging and storage conditions

FDA has treated levothyroxine as a product requiring close attention to bioequivalence and therapeutic consistency. [5] Manufacturing quality can therefore create a practical barrier even when patent protection is weak.

A manufacturer that repeatedly experiences shortages, recalls or potency deviations can lose pharmacy and payer confidence. Conversely, reliable supply can preserve contracts and dispensing volume without creating legally enforceable exclusivity.

What FDA regulatory issues affect THYRO-TABS?

FDA risk for THYRO-TABS is concentrated in quality and supply rather than clinical innovation.

Key regulatory areas include:

Bioequivalence

Levothyroxine products must demonstrate bioequivalence under FDA requirements applicable to the dosage form and strength. Small differences in exposure can matter clinically because the therapeutic window is relatively narrow.

Manufacturing compliance

The product is vulnerable to:

• Good manufacturing practice findings
• Batch failures
• Potency deviations
• Cross-contamination
• Stability failures
• Inadequate investigations
• Packaging and labeling errors

Labeling and substitution

Pharmacy substitution depends on FDA therapeutic-equivalence determinations and applicable state law. Consistent product identification is important because changes may lead to thyroid-stimulating hormone fluctuations or patient complaints.

Supply continuity

A shortage affecting one manufacturer can temporarily increase sales for other suppliers. That benefit may be difficult to retain if competitors restore supply quickly.

How strong is the THYRO-TABS patent estate?

The patent estate is weak as a source of exclusivity and moderate as a technical barrier only to the extent that formulation, manufacturing or analytical know-how improves reliability.

Dimension	Assessment
Core molecule protection	Weak or absent
Formulation differentiation	Limited
Manufacturing know-how	Potentially meaningful
Regulatory barrier	Moderate
Switching resistance	Moderate in selected patients
Pricing power	Low
Litigation leverage	Low
Supply-chain value	Potentially high
Long-term moat	Limited

The strongest defensible asset is likely regulatory execution combined with dependable supply, not patent ownership.

Which companies compete with THYRO-TABS?

THYRO-TABS faces competition from both branded and generic suppliers.

Competitor	Market position
Synthroid	Major branded levothyroxine product with strong prescriber recognition
Levoxyl	Branded levothyroxine competitor
Unithroid	Branded levothyroxine product
Euthyrox	Branded levothyroxine product in relevant markets
Generic levothyroxine	Broad supplier base and substantial price competition
Tirosint	Soft-gel formulation with differentiated delivery characteristics
Tirosint-SOL	Liquid formulation with differentiated administration profile

Branded products may retain patients through prescriber preference, product familiarity and perceived consistency. Generic tablets compete primarily on price, availability and payer acceptance.

What generic entry risks exist for THYRO-TABS?

Generic entry is already embedded in the product’s market structure. The principal risks are not a single future entrant but continued competition from existing manufacturers and additional suppliers.

The main risks are:

• Contract losses to lower-cost suppliers
• Reduced reimbursement
• Pharmacy substitution
• Wholesale price pressure
• Competitor shortages ending
• Product recalls
• FDA manufacturing action
• Increased customer concentration
• Loss of therapeutic-equivalence status
• Inability to maintain all tablet strengths

The principal upside scenario is a supply disruption affecting competitors while THYRO-TABS remains available and compliant. That can produce temporary volume gains, but it does not establish durable market power.

What patent litigation and settlement agreements affect THYRO-TABS?

No major current patent litigation or settlement agreement is identified as a primary determinant of THYRO-TABS economics. The product does not appear to depend on a contested patent position comparable to a protected branded drug.

Any future dispute would more likely involve:

• Contract manufacturing
• Product liability
• Regulatory compliance
• Distribution rights
• Trademark or branding
• Formulation or process patents
• Supplier indemnification

Patent settlements are unlikely to produce a material exclusivity transfer for the core THYRO-TABS product.

What geographic coverage does THYRO-TABS have?

THYRO-TABS is principally a U.S. commercial product. Its value is tied to FDA approval, U.S. pharmacy distribution and U.S. reimbursement channels.

International markets use different brand names, regulatory approvals and distribution arrangements. A U.S. product label does not establish global rights. Geographic expansion would require:

• Country-specific marketing authorization
• Local pharmacopoeial compliance
• Distribution and pricing agreements
• Local pharmacovigilance
• Product registration for each strength
• Potentially different excipient or packaging requirements

The product’s geographic patent value is limited because levothyroxine is an established active ingredient with broad generic availability.

What manufacturing and intellectual-property barriers affect THYRO-TABS?

Manufacturing is the more important barrier. Levothyroxine has a small active dose, making uniformity and process control critical. A supplier must manage active pharmaceutical ingredient quality, blending, compression, testing, packaging and stability across multiple strengths.

The main operational barriers are:

• Qualified API sourcing
• Reliable low-dose blending
• Validated analytical testing
• Stability across shelf life
• FDA inspection readiness
• Capacity for multiple strengths
• Consistent packaging and labeling
• Backup manufacturing capability

These barriers can protect revenue indirectly by reducing shortages and compliance events. They do not prevent competitors from entering the market if competitors can meet FDA standards.

Key Takeaways

• THYRO-TABS is a levothyroxine sodium tablet competing in a mature U.S. generic market.
• Product-specific revenue, profit and prescription data are not publicly disclosed.
• The commercial model depends on volume, reimbursement, supply reliability and manufacturing execution.
• No active core-molecule patent is expected to provide meaningful exclusivity.
• Orange Book patent rights and Paragraph IV litigation are not central to the product’s current value.
• Formulation and manufacturing know-how may support quality differentiation but provide limited market exclusivity.
• FDA compliance, potency consistency and supply continuity are the most important operating risks.
• The strongest upside is temporary volume capture during competitor shortages.
• The principal long-term risk is generic price compression combined with loss of contracts or supply interruptions.
• THYRO-TABS has recurring chronic-use demand but limited pricing power and a narrow patent moat.

FAQs About THYRO-TABS Market and Exclusivity

Is THYRO-TABS a branded drug or a generic drug?

THYRO-TABS is best analyzed as a branded-generic or generic levothyroxine product. Its commercial position does not resemble that of a newly launched branded drug with active composition-of-matter protection.

Can pharmacies substitute generic levothyroxine for THYRO-TABS?

Substitution depends on FDA therapeutic-equivalence status, the prescribed product, state law and payer rules. Physicians may recommend consistent use of one levothyroxine product and thyroid-stimulating hormone monitoring after a switch.

Does THYRO-TABS have biosimilar competition?

No. Levothyroxine is a small-molecule drug, not a biologic. Its competitors are generic and branded levothyroxine products, not biosimilars.

Is THYRO-TABS exposed to FDA drug shortages?

Yes. Like other levothyroxine products, it can be affected by API constraints, manufacturing interruptions, quality failures or distribution problems. A shortage can increase short-term demand but may also damage commercial relationships if supply is unreliable.

What would increase the value of THYRO-TABS?

The most credible value drivers are sustained supply reliability, additional pharmacy or payer contracts, improved manufacturing economics, retention of therapeutic-equivalence status and temporary market-share gains during competitor shortages.

References

1. U.S. National Library of Medicine. (n.d.). THYRO-TABS levothyroxine sodium tablet: Drug label. DailyMed.
2. Jonklaas, J., Bianco, A. C., Bauer, A. J., Burman, K. D., Cappola, A. R., Celi, F. S., Cooper, D. S., Kim, B. W., Peeters, R. P., Rosenthal, M. S., & Sawka, A. M. (2014). Guidelines for the treatment of hypothyroidism. Thyroid, 24(12), 1670-1751.
3. Lannett Company, Inc. (2022). Annual report on Form 10-K. U.S. Securities and Exchange Commission.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.
5. U.S. Food and Drug Administration. (n.d.). Levothyroxine sodium tablets: Product-specific guidance. FDA.