QUESTRAN Drug Patent Profile

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

Questran is a drug marketed by Bristol Myers and Apothecon and is included in three NDAs.

The generic ingredient in QUESTRAN is cholestyramine. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the cholestyramine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Questran

A generic version of QUESTRAN was approved as cholestyramine by EPIC PHARMA LLC on August 15^th, 1996.

Summary for QUESTRAN

US Patents:	0
Applicants:	2
NDAs:	3
Clinical Trials:	9
DailyMed Link:	QUESTRAN at DailyMed

Recent Clinical Trials for QUESTRAN

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

Sponsor	Phase
Centre Hospitalier Universitaire de Nice	N/A
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1

See all QUESTRAN clinical trials

US Patents and Regulatory Information for QUESTRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers	QUESTRAN	cholestyramine	POWDER;ORAL	016640-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apothecon	QUESTRAN	cholestyramine	TABLET;ORAL	073403-002	Dec 27, 1999		DISCN	No	No
Bristol Myers	QUESTRAN	cholestyramine	POWDER;ORAL	016640-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apothecon	QUESTRAN	cholestyramine	TABLET;ORAL	073403-001	Apr 28, 1994		DISCN	No	No
Bristol Myers	QUESTRAN LIGHT	cholestyramine	POWDER;ORAL	019669-003	Dec 5, 1988		DISCN	Yes	No
Bristol Myers	QUESTRAN LIGHT	cholestyramine	POWDER;ORAL	019669-001	Dec 5, 1988		DISCN	Yes	No

# Questran Market Dynamics, Patent Status, Competitive Position, and Financial Trajectory

Last updated: August 8, 2026

Questran is the branded form of cholestyramine, a mature bile acid sequestrant used primarily for hypercholesterolemia and bile-acid-related diarrhea or pruritus. Its original market exclusivity has expired, generic cholestyramine is widely available, and no active Orange Book patent appears to create a material barrier to generic entry. Questran remains commercially relevant as a low-growth prescription product, but its financial trajectory is shaped by price competition, limited differentiation, adherence problems, and substitution by newer lipid-lowering therapies.

What is Questran and how is it used?

Questran contains cholestyramine resin, a nonabsorbed anion-exchange resin that binds bile acids in the intestine. The resulting increase in hepatic conversion of cholesterol to bile acids lowers circulating low-density lipoprotein cholesterol.

The FDA-approved label identifies Questran for:

• Reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia.
• Relief of pruritus associated with partial biliary obstruction.
• Clinical use in bile-acid malabsorption and related diarrhea, although some uses are outside the principal labeled indication.[1]

Questran is supplied as an oral powder that is mixed with liquid or soft food. Questran Light is a lower-calorie formulation. Neither product is an injectable, biologic, controlled substance, or modified-release product.

What formulations are protected by Questran?

Questran and Questran Light use powder-for-suspension formulations. The products have formulation and manufacturing characteristics, including resin particle properties, flavoring, dosing presentation, and suspension performance. These characteristics may support commercial differentiation, but they do not appear to provide current patent exclusivity comparable to a modern branded formulation product.

The principal commercial limitations are practical:

• Poor palatability for some patients.
• Required mixing before administration.
• Constipation and gastrointestinal adverse effects.
• Binding interactions with other oral medicines.
• A need to separate administration from many concomitant drugs.

The label recommends administering other oral drugs at least one hour before or four to six hours after Questran because cholestyramine can reduce absorption.[1]

When did Questran lose exclusivity?

Questran lost meaningful market exclusivity decades ago. Cholestyramine is an established active ingredient with generic equivalents marketed by multiple manufacturers.

FDA regulatory timeline

Event	Approximate timing	Commercial significance
Original FDA approval of cholestyramine products	1970s	Established the drug as a prescription bile acid sequestrant
Generic cholestyramine entry	Historical, following pioneer exclusivity	Removed single-brand control over the active ingredient
Questran and Questran Light continued marketing	Current	Brand remains available despite generic competition
Modern Orange Book patent protection	No material unexpired patent identified	Limited protection against ANDA-based competition
Current competitive phase	Mature product cycle	Volume is stable or declining, while price pressure persists

The FDA Orange Book is the principal source for listed patents and regulatory exclusivity associated with approved drugs. Public Orange Book information does not indicate an active Questran patent estate that would materially delay generic competition.[2]

What is the Orange Book status of Questran?

Questran is an approved prescription drug marketed as cholestyramine for oral suspension. Its Orange Book position is commercially weak compared with newer small-molecule products.

Orange Book and regulatory assessment

Issue	Questran status
Active ingredient	Cholestyramine resin
Dosage form	Oral powder for suspension
Therapeutic class	Bile acid sequestrant
FDA pathway	Original NDA product with generic ANDA competition
Generic equivalents	Available
Unexpired composition patent	No material current protection identified
Unexpired formulation patent	No material current protection identified
Pediatric exclusivity	Not a current commercial barrier
Orphan exclusivity	Not applicable
Biologic exclusivity	Not applicable
Biosimilar pathway	Not applicable

The practical effect is that a generic manufacturer can compete through an abbreviated new drug application if it demonstrates pharmaceutical equivalence and bioequivalence or satisfies the applicable regulatory requirements for the product. The drug's nonabsorbed mechanism and powder dosage form can make product characterization more operationally complex than a conventional tablet, but those issues are regulatory and manufacturing considerations rather than patent barriers.

How many patents cover Questran?

No active patent estate of commercial significance has been identified for Questran based on the public Orange Book record and the age of the product.

What patent protection remains?

The relevant patent categories are:

1. Original composition patents covering cholestyramine or the resin technology.
2. Formulation patents covering powder presentation, flavoring, or suspension characteristics.
3. Method-of-use patents covering cholesterol reduction, pruritus, or bile-acid diarrhea.
4. Manufacturing patents covering resin preparation and processing.

The original composition and use patents are historical. Any remaining third-party patent relating to a manufacturing process would not necessarily block generic sale because an ANDA applicant can use a noninfringing process or certify under the applicable patent framework.

Are there Paragraph IV challenges to Questran?

Paragraph IV litigation is not a central current risk for Questran. The product has long been exposed to generic competition, and no major active Paragraph IV dispute is publicly associated with the mature Questran brand in the commonly used FDA and court-record sources.

The commercial risk is therefore the reverse of a typical launch-stage brand: Questran is already in a post-exclusivity environment, and the principal question is whether the brand can retain prescribing or pharmacy preference despite generic substitution.

Which companies compete with Questran?

Questran competes with generic cholestyramine manufacturers and with other bile acid sequestrants. It also faces indirect competition from statins, ezetimibe, PCSK9 inhibitors, bempedoic acid, fibrates, omega-3 products, and newer lipid-management combinations.

Direct competitors

Product	Active ingredient	Form	Competitive position
Questran	Cholestyramine	Powder for oral suspension	Legacy branded product
Questran Light	Cholestyramine	Powder for oral suspension	Lower-calorie branded formulation
Generic cholestyramine	Cholestyramine	Powder for oral suspension	Primary direct price competitor
Colestid	Colestipol	Tablet or granules, depending on product	Alternative bile acid sequestrant
Welchol	Colesevelam	Tablet and oral suspension forms	Better convenience for some patients, generally higher acquisition cost

Generic cholestyramine has the strongest direct pricing advantage. Colesevelam has a more modern product presentation and a different interaction profile, but it remains constrained by cost, gastrointestinal tolerability, and the availability of more effective LDL-lowering therapies.

How does Questran compare with newer cholesterol drugs?

Questran has a low-cost and nonabsorbed mechanism, but its LDL-lowering performance and administration burden limit its role in contemporary lipid management.

Factor	Questran	Statins	Ezetimibe	PCSK9 inhibitors
Route	Oral	Oral	Oral	Injectable
Systemic absorption	Minimal or none	Systemic	Systemic	Systemic biologic
LDL reduction	Moderate	Moderate to high	Moderate	High
Generic availability	Yes	Yes	Yes	Limited, product-dependent
Administration burden	High	Low	Low	Moderate
Main use today	Alternative or adjunctive therapy	First-line	Add-on or alternative	High-risk or refractory patients
Patent risk	Minimal	Generally mature	Varies by product	Relevant for some products

Questran can be useful when systemic lipid-lowering agents are poorly tolerated or contraindicated. It can also have value in bile-acid diarrhea and cholestatic pruritus, where statins and PCSK9 inhibitors do not address the same mechanism.

What is the financial trajectory for Questran?

Questran's standalone revenue is not publicly disclosed in a reliable, product-level manner. Public company filings generally report sales by broader product groups, operating segments, or portfolios rather than separating Questran revenue. A precise revenue series, market share percentage, or product-level margin cannot be established from issuer filings.

Financial trajectory

The product's likely financial profile is:

• Historical peak value during the period of branded control.
• Long-term revenue erosion after generic entry.
• Continuing unit demand from a narrow clinical base.
• Price compression from generic substitution.
• Low commercial investment relative to protected or high-growth drugs.
• Limited upside except through channel management, supply continuity, or niche indications.

Questran is best classified as a mature, low-growth legacy pharmaceutical asset. Its value depends less on patent-protected pricing and more on manufacturing reliability, formulary placement, brand recognition, and the economics of a small established patient population.

Revenue exposure

Questran's revenue exposure is likely modest relative to the portfolios of companies selling high-value oncology, immunology, diabetes, or specialty medicines. The absence of publicly reported product-level sales prevents a defensible dollar estimate.

For an acquirer, the relevant valuation variables are:

• Net price after wholesaler and pharmacy discounts.
• Generic substitution rate.
• Annual prescription volume.
• Cost of resin, flavoring, packaging, and quality testing.
• Product availability and back-order history.
• Channel concentration.
• Regulatory costs for maintaining the NDA and manufacturing network.

A mature brand can generate cash flow if manufacturing costs are low and competition is fragmented. The same brand can become economically unattractive if generic prices fall below sustainable levels or if production requires specialized equipment and extensive quality controls.

How strong is the patent estate for Questran?

The Questran patent estate is weak from a modern commercial perspective because the active ingredient and principal clinical uses have been known for many years.

Patent-strength assessment

Criterion	Assessment
Composition-of-matter protection	Expired or commercially irrelevant
Formulation protection	No material current Orange Book barrier identified
Method-of-use protection	Historical uses are broadly established
Manufacturing protection	Potentially relevant only on a process-specific basis
Generic entry barrier	Low
Litigation leverage	Low
Licensing leverage	Low
Life-cycle management potential	Limited

The remaining defensible assets are more likely to be regulatory know-how, manufacturing specifications, trademarks, supplier relationships, and distribution infrastructure than enforceable patent rights.

What manufacturing and intellectual-property barriers affect generic entry?

Generic entry is legally straightforward but operationally dependent on product quality. Cholestyramine is a resin-based powder, so manufacturing consistency matters.

Potential barriers include:

• Control of particle-size distribution.
• Resin exchange capacity.
• Impurity and residual-solvent control.
• Flavoring and excipient compatibility.
• Suspension uniformity.
• Dose consistency across the container.
• Stability after packaging.
• Prevention of cross-contamination.
• Reliable supply of qualified resin and excipients.

These factors can create temporary supply constraints or discourage small manufacturers, but they do not produce durable exclusivity. A capable generic manufacturer can compete without acquiring the Questran brand or licensing its historical patents.

What litigation affects Questran?

No major ongoing patent litigation has been identified as a material driver of Questran's market outlook. The product's legal exposure is more likely to involve ordinary pharmaceutical matters, including:

• Product liability.
• Labeling and advertising compliance.
• Manufacturing quality.
• Supply and distribution contracts.
• Trademark rights involving the Questran name.
• Regulatory enforcement unrelated to patent exclusivity.

What settlement agreements affect Questran?

No prominent current Paragraph IV settlement agreement is associated with Questran's commercial position. Because generic cholestyramine has already entered the market, the classic brand-protection settlement model has limited relevance.

Are biosimilars a risk to Questran?

No. Biosimilar risk does not apply to Questran because cholestyramine is a small-molecule, nonbiologic active ingredient. The relevant competitive pathway is generic substitution through ANDAs or equivalent national procedures outside the United States.

What geographic markets matter for Questran?

The United States is the most relevant market for analyzing Questran's FDA, Orange Book, generic substitution, and patent position. In other jurisdictions, the product may be sold under different brand names or through generic cholestyramine products.

Geographic differences affect:

• Prescription reimbursement.
• Brand substitution rules.
• National marketing authorizations.
• Import and supply requirements.
• Trademark ownership.
• Reference-product status.
• Local pricing controls.

Patent protection for the original molecule is generally exhausted or expired in major markets. Country-specific formulation or trademark rights may remain, but they are unlikely to create a broad global exclusivity position.

What generic launch scenarios exist for Questran?

Because generic products are already marketed, future launch risk is incremental rather than transformational.

Base case

Generic cholestyramine maintains the majority of volume. Questran retains a smaller branded segment through physician familiarity, patient preference, product availability, or payer-specific coverage.

Downside case

Additional generic suppliers enter, pricing declines, and pharmacies substitute away from Questran. The brand becomes a low-volume product with limited commercial support.

Resilient-brand case

Questran preserves a niche where prescribers or patients prefer its flavor, tolerability, packaging, or supply reliability. Revenue remains modest but stable.

Supply-disruption case

A manufacturing interruption affecting generic suppliers creates temporary demand for Questran. This can increase short-term volume but is unlikely to establish durable long-term growth.

What licensing deals support Questran?

No major current licensing transaction has been identified as a central value driver for Questran. The product's commercial history includes changes in marketing and manufacturing responsibility, but the public record does not establish a material active licensing structure comparable to products supported by co-development, regional rights, or royalty-bearing patent licenses.

For diligence purposes, the key contractual issues are likely to be:

• NDA ownership or sponsorship.
• Manufacturing and packaging agreements.
• Wholesale distribution.
• Trademark rights.
• Pharmacovigilance responsibilities.
• Product-quality agreements.
• Territory-specific commercialization rights.

Key Takeaways

• Questran is cholestyramine, a mature bile acid sequestrant with FDA-approved use in hypercholesterolemia.
• Generic cholestyramine is the primary direct competitor.
• The product has no material current Orange Book patent barrier identified.
• Paragraph IV litigation and biosimilar risk are not significant drivers.
• Revenue is not separately disclosed in public filings, preventing a reliable standalone sales estimate.
• The financial profile is mature, low-growth, and exposed to generic price erosion.
• Remaining value lies in brand recognition, supply reliability, manufacturing capability, and niche clinical uses.
• Newer lipid-lowering therapies limit Questran's role in mainstream LDL management.
• Bile-acid diarrhea and cholestatic pruritus provide non-lipid niches that may support continued demand.
• Generic launch risk is already realized; future risk is further substitution and price compression.

FAQs

Is Questran still commercially available?

Yes. Questran and cholestyramine products remain available as prescription oral powders, although availability can vary by manufacturer, wholesaler, and pharmacy.

Can Questran be replaced by generic cholestyramine?

Yes. Generic cholestyramine is the direct therapeutic and pharmaceutical substitute for Questran. Substitution depends on prescription instructions, state law, payer policy, and product availability.

Does Questran have an FDA-granted market exclusivity period today?

No current exclusivity period appears to provide meaningful commercial protection. The product is in the post-exclusivity generic market.

Is Questran more valuable for cholesterol or bile-acid diarrhea?

Its commercial value may be more defensible in bile-acid-related gastrointestinal and cholestatic conditions because newer LDL-lowering therapies compete directly in hypercholesterolemia, while fewer products address bile-acid binding.

Could Questran become an attractive licensing or acquisition target?

Only as a niche mature-product asset. Its attractiveness would depend on low manufacturing costs, reliable supply, favorable net pricing, and a defensible distribution position rather than patent exclusivity or high growth.

References

1. U.S. Food and Drug Administration. (2018). Questran cholestyramine for oral suspension prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. National Library of Medicine. (2024). DailyMed: Questran cholestyramine powder, for suspension.
4. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs.
5. Grundy, S. M., Stone, N. J., Bailey, A. L., et al. (2019). 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol. Circulation, 139(25), e1082-e1143.

DrugChatter Q&A for QUESTRAN

Questran mechanism of action?