LITHOBID Drug Patent Profile
When do Lithobid patents expire, and when can generic versions of Lithobid launch?
Lithobid is a drug marketed by Ani Pharms and is included in one NDA.
The generic ingredient in LITHOBID is lithium carbonate. There is one drug master file entry for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lithobid
A generic version of LITHOBID was approved as lithium carbonate by HIKMA on January 29th, 1982.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for LITHOBID?
- What are the global sales for LITHOBID?
- What is Average Wholesale Price for LITHOBID?
Summary for LITHOBID
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 99 |
| Clinical Trials: | 13 |
| Patent Applications: | 3,948 |
| Drug Prices: | Drug price information for LITHOBID |
| What excipients (inactive ingredients) are in LITHOBID? | LITHOBID excipients list |
| DailyMed Link: | LITHOBID at DailyMed |
Recent Clinical Trials for LITHOBID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| William V. Bobo, M.D. | Phase 2 |
| Alzheimer's Drug Discovery Foundation | Phase 2 |
| Johns Hopkins University | Phase 2 |
Pharmacology for LITHOBID
| Drug Class | Mood Stabilizer |
US Patents and Regulatory Information for LITHOBID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | LITHOBID | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 018027-001 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LITHOBID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ani Pharms | LITHOBID | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 018027-001 | Approved Prior to Jan 1, 1982 | 4,264,573 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
LITHOBID Market Dynamics, Patent Status, Competition, and Financial Trajectory
LITHOBID is an extended-release lithium carbonate product used for acute manic episodes and maintenance treatment in bipolar disorder. Its commercial profile is mature and largely genericized. The product has limited standalone financial transparency, no clear active patent barrier protecting the brand, and substantial substitution risk from immediate-release and extended-release lithium carbonate products. Revenue exposure is more relevant to the product owner’s established-brands portfolio than to the overall lithium market.
What is LITHOBID and how is it regulated?
LITHOBID is an extended-release tablet containing lithium carbonate. The product is marketed in the United States as a prescription drug and is used in the treatment of bipolar disorder, including manic episodes and maintenance therapy.[1]
| Attribute | LITHOBID profile |
|---|---|
| Active ingredient | Lithium carbonate |
| Dosage form | Extended-release oral tablet |
| Common strength | 300 mg |
| Therapeutic category | Mood stabilizer |
| Primary indication | Bipolar disorder |
| FDA pathway | Full NDA product with generic ANDA competition |
| Biosimilar relevance | None |
| Prescription status | Prescription-only |
| Principal commercial risk | Generic substitution and supply volatility |
Lithium has a narrow therapeutic index. Patients require serum concentration monitoring, and changes between formulations can affect absorption, tolerability, and clinical management. These characteristics create some prescriber and patient resistance to switching, but they do not eliminate generic substitution.
The FDA label warns of lithium toxicity, renal impairment, thyroid effects, drug interactions, and dehydration-related concentration changes.[1] These clinical requirements support continued demand but constrain the product’s use to patients who can receive monitoring and follow-up care.
What patents protect LITHOBID?
No strong, currently visible Orange Book patent barrier appears to protect LITHOBID’s commercial market. The product’s underlying active ingredient, lithium carbonate, is an old compound, and the extended-release technology has been commercially established for decades.
The relevant intellectual-property position is therefore different from that of a recently approved specialty drug:
| IP category | LITHOBID position | Commercial effect |
|---|---|---|
| Compound patent | Expired or unavailable for this mature ingredient | No compound exclusivity |
| Core formulation patent | No material blocking patent identified in the public Orange Book record | Limited barrier to extended-release competition |
| Method-of-use patent | No material current exclusivity identified | No meaningful protection for bipolar treatment |
| Regulatory exclusivity | No current new-drug exclusivity expected | Generic competition permitted |
| Manufacturing know-how | Potentially relevant for release characteristics and quality control | May create operational, but not durable legal, protection |
The main defensible asset is manufacturing consistency. Extended-release lithium products must meet dissolution, assay, content-uniformity, and stability requirements. Those requirements can increase development and quality-control costs, but they do not create the equivalent of a live patent moat.
What is the Orange Book status of LITHOBID?
LITHOBID is subject to generic competition under the abbreviated new drug application framework. FDA Orange Book records identify the reference product and any listed patents or exclusivity associated with an NDA.[2] The publicly available record does not indicate a material current patent or regulatory-exclusivity block that would prevent ANDA approvals for lithium carbonate extended-release tablets.
The practical result is that generic manufacturers can compete through ANDAs demonstrating pharmaceutical equivalence and bioequivalence. An ANDA applicant may submit a Paragraph IV certification if it contests an Orange Book patent, but the absence of a significant active patent estate reduces the litigation value of that pathway.
When does LITHOBID lose exclusivity?
LITHOBID has already lost meaningful market exclusivity. The product is in the mature generic phase rather than the protected or early-generic phase.
There is no commercially important future exclusivity cliff comparable to the loss of exclusivity for a patented branded drug. Generic entry has already occurred, and substitution pressure is embedded in the product’s current economics.
LITHOBID exclusivity timeline
| Period | Market status | Financial implication |
|---|---|---|
| Original launch period | Branded lithium extended-release product | Higher pricing and limited direct competition |
| Patent and exclusivity maturity | Core product protection expired | ANDA competition becomes possible |
| Current period | Mature brand with generic alternatives | Lower pricing, fragmented volume, supply-driven purchasing |
| Forward outlook | Continued generic substitution | Revenue depends on availability, contracts, and channel execution |
The relevant commercial event is not a future patent expiration date. It is the ongoing erosion of branded volume as pharmacies, payers, and health systems use lower-cost generic alternatives.
How many patents cover LITHOBID?
The commercially important patent count is effectively zero based on the public Orange Book position available for the product. No active patent estate comparable to those protecting newer extended-release or long-acting medicines is apparent.
This does not mean that every manufacturing process, supplier agreement, or formulation detail is free of intellectual-property rights. It means that no visible patent portfolio is positioned to prevent ordinary generic competition in the United States.
The absence of a blocking patent also limits the usefulness of patent litigation as a revenue-defense strategy. A manufacturer would generally rely on product differentiation, supply reliability, contracting, and regulatory execution rather than on infringement enforcement.
Which companies compete with LITHOBID?
LITHOBID competes across several product types:
- Generic lithium carbonate extended-release tablets.
- Generic immediate-release lithium carbonate tablets and capsules.
- Other mood stabilizers used in bipolar disorder.
- Branded and generic atypical antipsychotics.
- Alternative maintenance therapies such as valproate, lamotrigine, and carbamazepine.
The closest competition comes from generic extended-release lithium carbonate. Immediate-release lithium products are not perfect substitutes because release characteristics, dosing schedules, and serum concentration profiles differ. In practice, however, they compete for the same treated population when prescribers and pharmacists can manage the dosing change.
The broader bipolar-disorder market includes generic quetiapine, olanzapine, risperidone, aripiprazole, lamotrigine, divalproex, and carbamazepine. These drugs have different efficacy and safety profiles, so they compete clinically rather than as direct pharmaceutical equivalents.
What is the financial trajectory for LITHOBID?
Standalone LITHOBID revenue is not separately disclosed in the public financial reporting of its commercial owner. The product should therefore be analyzed as an established-brand asset rather than as a transparent, independently reported franchise.
Its financial trajectory has four characteristics:
| Financial driver | Expected direction | Explanation |
|---|---|---|
| Unit demand | Stable to modestly growing | Bipolar disorder treatment remains chronic and recurring |
| Net price | Downward or flat | Generic substitution and payer pressure limit price expansion |
| Gross margin | Vulnerable | Small-volume manufacturing and compliance costs can pressure margins |
| Revenue quality | Mixed | Chronic demand is durable, but channel access and supply determine sales |
Lithium demand is relatively resilient because many patients remain on long-term maintenance therapy. The market is not highly dependent on new diagnosis growth. It depends on continued treatment, adherence, monitoring, and product availability.
The brand can retain a price premium where physicians or patients prefer the labeled extended-release product, where generic supply is inconsistent, or where payer formularies do not force substitution. That premium is constrained by the availability of lower-cost lithium carbonate products.
What does LITHOBID contribute to its owner’s revenue?
The product’s contribution is likely modest relative to the total revenue of a diversified pharmaceutical company. It is not a high-growth asset and is unlikely to be a primary driver of consolidated revenue unless the owner has a concentrated portfolio of mature products.
Its strategic value may be greater than its absolute sales contribution when it:
- Uses existing manufacturing and distribution infrastructure.
- Generates recurring prescriptions with limited promotional spending.
- Complements a portfolio of psychiatric or hospital products.
- Benefits from temporary generic shortages.
- Supports pharmacy and wholesaler relationships.
This profile creates a cash-flow asset with limited expansion potential. Revenue can rise temporarily during competitor shortages, but those gains are difficult to forecast as permanent growth.
What manufacturing and supply risks affect LITHOBID?
Manufacturing execution is a more important barrier than patent protection. Lithium carbonate extended-release products require controlled release performance and consistent tablet quality. Problems with raw-material supply, dissolution testing, packaging, batch release, or contract manufacturing can cause shortages or customer switching.
Supply risks include:
- Limited manufacturer participation in a low-margin market.
- Dependence on qualified lithium carbonate suppliers.
- Batch failures or extended-release dissolution deviations.
- FDA manufacturing observations or remediation.
- Wholesaler inventory reductions.
- Increased demand following competitor shortages.
- Hospital and pharmacy substitution when a specific National Drug Code is unavailable.
A shortage can temporarily improve LITHOBID sales and pricing, but it can also damage the product’s market position if pharmacies permanently substitute another supplier.
Are there Paragraph IV challenges or LITHOBID patent lawsuits?
No major, publicly prominent Paragraph IV campaign or settlement involving a material LITHOBID patent barrier is apparent. That outcome is consistent with the product’s mature formulation and limited visible Orange Book protection.
The litigation profile is therefore low compared with patented specialty drugs. The more relevant legal risks are likely to involve:
- Product liability claims related to lithium toxicity.
- Manufacturing or quality disputes.
- Contract and supply disagreements.
- FDA compliance actions.
- Pricing, rebate, or distribution disputes.
There is no evident settlement structure delaying generic entry because generic entry is already established.
What is the FDA regulatory status of LITHOBID?
LITHOBID remains an FDA-regulated prescription product with labeling for bipolar disorder. The FDA-approved labeling requires clinical monitoring and identifies renal, thyroid, electrolyte, pregnancy, and drug-interaction considerations.[1]
The product is not a biologic and has no biosimilar exposure. Its competitive pathway is generic substitution through ANDAs rather than biosimilar interchangeability.
FDA approval does not guarantee uninterrupted commercial availability. A product can remain approved while experiencing manufacturing interruptions, discontinuation by a supplier, or limited distribution.
How does LITHOBID compare with generic lithium carbonate?
| Factor | LITHOBID | Generic lithium carbonate ER |
|---|---|---|
| Regulatory status | Branded reference product | ANDA-approved alternatives |
| Price | Usually higher | Usually lower |
| Prescriber familiarity | Established | Depends on manufacturer |
| Substitution pressure | High | High among generic suppliers |
| Patent protection | No material current barrier identified | No major entry barrier identified |
| Supply advantage | Depends on owner and distributors | Varies by manufacturer |
| Clinical monitoring | Required | Required |
| Revenue outlook | Mature and limited | Volume-driven, price-competitive |
The brand’s main advantage is continuity of product identity. Its main disadvantage is price. In a market with interchangeable alternatives, that tradeoff generally favors generics unless supply conditions or patient-specific considerations support continued branded use.
What generic launch scenarios exist for LITHOBID?
Three scenarios define the forward market:
Base case: continued mature generic erosion
Generic extended-release products retain most price-sensitive volume. LITHOBID maintains a smaller branded segment supported by prescriber familiarity, patient continuity, and selected payer coverage.
Upside case: competitor supply disruption
A shortage or withdrawal by a major generic supplier shifts prescriptions toward available LITHOBID inventory. Sales and net price improve temporarily. The gain fades when generic supply returns.
Downside case: additional reliable generic supply
More ANDA suppliers increase pharmacy substitution and reduce the brand’s distribution leverage. LITHOBID volume and net pricing decline, particularly in managed-care and government channels.
What is the geographic coverage of LITHOBID?
The commercially material market is the United States, where LITHOBID is regulated by the FDA and listed within the U.S. prescription-drug framework. International lithium carbonate markets may use different brands, strengths, release technologies, and regulatory classifications.
U.S. revenue potential is constrained by generic substitution and the mature nature of lithium therapy. International expansion would require separate registrations, local manufacturing or distribution arrangements, and market-specific evidence for extended-release performance.
Key Takeaways
- LITHOBID is a mature extended-release lithium carbonate product for bipolar disorder.
- Its principal market is the United States.
- The product has no visible active patent estate that materially blocks generic competition.
- Regulatory exclusivity has expired, and generic substitution is established.
- No major Paragraph IV campaign or settlement appears to define the current market.
- Standalone LITHOBID revenue is not publicly disclosed.
- Financial performance depends on chronic demand, formulary position, manufacturing reliability, and temporary supply disruptions.
- The product has low biosimilar risk because lithium carbonate is a small-molecule drug, not a biologic.
- Manufacturing consistency is more important than patent strength.
- The most probable long-term trajectory is stable-to-declining branded revenue with occasional supply-driven increases.
FAQs
Is LITHOBID still commercially available?
LITHOBID has an FDA-recognized product identity and remains associated with lithium carbonate extended-release therapy. Actual availability depends on manufacturer production, wholesaler inventory, and pharmacy distribution.
Can pharmacies automatically substitute generic lithium for LITHOBID?
Substitution depends on state pharmacy law, FDA therapeutic-equivalence designations, payer rules, and the specific generic formulation. Extended-release and immediate-release products should not be treated as identical without prescriber and pharmacist review.
Does LITHOBID have a 30-year patent term remaining?
No. Lithium carbonate and the established extended-release product technology are mature. No material remaining patent term is apparent from the public Orange Book position.
Is LITHOBID a high-growth pharmaceutical asset?
No. It is better characterized as a mature, recurring-revenue established brand. Growth is more likely to come from temporary supply shortages or distribution gains than from structural market expansion.
Could LITHOBID sales increase if generic lithium manufacturers exit?
Yes. A reduction in generic supply could shift prescriptions to the branded product and support higher net pricing. The effect would likely be temporary unless the supply contraction became permanent.
References
- U.S. Food and Drug Administration. (n.d.). Lithobid (lithium carbonate) extended-release tablets prescribing information. DailyMed.
- U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. U.S. Department of Health and Human Services.
- National Library of Medicine. (n.d.). Lithium carbonate extended-release tablet drug labeling. DailyMed.
More… ↓
