ACTIGALL Drug Patent Profile

Which patents cover Actigall, and when can generic versions of Actigall launch?

Actigall is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in ACTIGALL is ursodiol. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Actigall

A generic version of ACTIGALL was approved as ursodiol by EPIC PHARMA on March 14^th, 2000.

Summary for ACTIGALL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	6
Patent Applications:	5,786
Drug Prices:	Drug price information for ACTIGALL
What excipients (inactive ingredients) are in ACTIGALL?	ACTIGALL excipients list
DailyMed Link:	ACTIGALL at DailyMed

See drug prices for ACTIGALL

Recent Clinical Trials for ACTIGALL

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

Sponsor	Phase
The University of Texas Health Science Center at San Antonio	Phase 2
Phoenix Children's Hospital	Phase 1
Children's Hospital Los Angeles	Phase 1

See all ACTIGALL clinical trials

US Patents and Regulatory Information for ACTIGALL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	ACTIGALL	ursodiol	CAPSULE;ORAL	019594-001	Dec 31, 1987		DISCN	No	No
Teva Branded Pharm	ACTIGALL	ursodiol	CAPSULE;ORAL	019594-002	Dec 31, 1987	AB	RX	Yes	Yes

Actigall Market Dynamics, Patent Status, Generic Competition, and Financial Trajectory

Last updated: September 7, 2026

Actigall is the U.S. brand name for ursodiol, a genericized bile acid used primarily for primary biliary cholangitis and dissolution of selected cholesterol gallstones. Its commercial profile is mature and low-growth. The drug has no meaningful market exclusivity, faces broad generic competition, and has limited standalone revenue visibility because its manufacturer does not report Actigall sales separately. Financial performance is therefore driven by residual branded demand, reimbursement, supply reliability, and generic price competition rather than patent protection.

What is Actigall and how is it used?

Actigall contains ursodiol, also called ursodeoxycholic acid. The FDA-approved capsule product is indicated for:

• The treatment of primary biliary cholangitis, formerly called primary biliary cirrhosis.
• The dissolution of radiolucent, noncalcified gallbladder stones in patients who are not candidates for cholecystectomy or who prefer nonsurgical treatment.
• Reduction in the risk of gallstone formation during rapid weight loss, depending on the approved product labeling and dosage form. [1]

Actigall is available in 300 mg capsules. Ursodiol is also sold in generic capsules and tablets, including 250 mg and 500 mg presentations. Dosing depends on the indication and patient weight. PBC treatment generally requires chronic use, while gallstone dissolution requires treatment over months and is limited to selected patients.

How large is the addressable patient market?

The largest recurring demand segment is PBC. The disease is uncommon but requires long-term treatment. Ursodiol remains a standard first-line therapy for many PBC patients. Gallstone dissolution is a smaller and less predictable segment because surgery is usually preferred for eligible patients and medical dissolution has a slow response rate.

Demand is influenced by:

• PBC diagnosis rates and treatment persistence.
• The number of patients intolerant of or inadequately controlled by newer PBC therapies.
• Gallstone prevalence and the availability of laparoscopic surgery.
• Generic substitution policies.
• Pharmacy purchasing and product shortages.
• Insurance coverage for branded Actigall versus generic ursodiol.

What is the FDA regulatory status of Actigall?

Actigall is an approved small-molecule prescription drug under FDA New Drug Application 20-675. The product’s initial U.S. approval dates to the late 1980s, making it a mature product with no remaining regulatory exclusivity of commercial significance. [2]

Regulatory item	Actigall status
Active ingredient	Ursodiol
Dosage form	Oral capsule
Common strength	300 mg
FDA application	NDA 20-675
Primary indications	PBC and selected cholesterol gallstones
Regulatory pathway	Original NDA
Current regulatory position	Approved, mature product
FDA exclusivity	Expired
Generic availability	Yes
Biosimilar pathway	Not applicable

Ursodiol is a chemically synthesized small molecule, not a biologic. Biosimilar risk does not apply. The relevant competitive threat is abbreviated new drug application, or ANDA, competition from generic manufacturers.

What patents protect Actigall?

Actigall has no commercially meaningful patent moat. The core composition-of-matter protection for ursodiol expired long ago, and the original product is well beyond the normal period of U.S. patent exclusivity.

The current commercial position is consistent with an off-patent product:

Protection category	Actigall position
Composition-of-matter patent	Expired or no longer commercially relevant
Original formulation protection	Expired
Method-of-use patents	No known active patent barrier preventing generic ursodiol use for the principal indications
Orange Book-listed patents	No meaningful active patent protection identified for the mature product
Regulatory exclusivity	Expired
Generic entry	Established

The FDA Orange Book is the controlling source for patent and exclusivity listings associated with approved small-molecule products. A current Orange Book review should be performed for litigation-grade diligence because listings can change and may vary by NDA. [3]

What formulations are protected by Actigall?

The commercial formulation is an oral ursodiol capsule. Generic manufacturers produce therapeutically equivalent capsules and, in some markets, tablets or compounded liquid preparations.

The formulation itself is not a durable barrier. Capsule manufacturing requires ordinary pharmaceutical controls, including:

• Assay and content uniformity.
• Dissolution performance.
• Stability testing.
• Control of impurities.
• Compliance with current good manufacturing practice requirements.

These requirements can create operational barriers for small suppliers but do not prevent generic competition. No high-value extended-release, injectable, depot, or device-linked Actigall formulation drives the brand’s market position.

When did Actigall lose exclusivity?

Actigall lost practical exclusivity many years ago. Generic ursodiol products entered the U.S. market after the original brand’s regulatory and patent protections expired. The product is now in the mature generic phase of its lifecycle.

The relevant exclusivity timeline is:

Period	Market event
Late 1980s	FDA approval of Actigall and establishment of the ursodiol brand
1990s and later	Expansion of use in PBC and gallstone management
Post-exclusivity period	FDA approval of generic ursodiol products
Current market	Multiple generic suppliers and limited branded differentiation

There is no credible basis to expect a patent-driven extension of Actigall exclusivity. Any future commercial protection would have to arise from a new formulation, a separate indication, manufacturing differentiation, or a new delivery technology rather than the existing Actigall capsule.

What is the Orange Book status of Actigall?

Actigall is an Orange Book-listed reference product because its approved NDA establishes the reference-drug record for generic ursodiol competition. That status does not mean the brand retains enforceable patent exclusivity.

Orange Book significance is limited to:

1. Identifying the reference listed drug.
2. Recording approved strengths and dosage forms.
3. Linking the reference drug to approved generic equivalents.
4. Displaying any patent or exclusivity information associated with the NDA.

For Actigall, the commercial issue is generic substitution, not a pending patent dispute. Generic applicants would ordinarily rely on an ANDA demonstrating pharmaceutical equivalence and bioequivalence to the reference product. [3]

Which companies are challenging Actigall?

Generic competition has already displaced most of the economic value of the brand. The relevant competitors are manufacturers of generic ursodiol rather than companies pursuing a high-profile Paragraph IV challenge.

Generic ursodiol suppliers in the U.S. market have included large and mid-sized generic manufacturers such as:

• Amneal Pharmaceuticals.
• Rising Pharma.
• Zydus Pharmaceuticals.
• Teva Pharmaceuticals.
• Dr. Reddy’s Laboratories.
• Other FDA-approved suppliers depending on current product availability.

The precise active supplier list changes as manufacturers enter, exit, or experience shortages. FDA’s Drugs@FDA and Orange Book databases are the appropriate sources for current ANDA and product-status verification. [3,4]

Have there been Paragraph IV challenges?

No major current Paragraph IV dispute is central to Actigall’s commercial outlook. Paragraph IV litigation is most economically important before generic entry, when a brand has meaningful remaining patent life. Actigall’s central patents and exclusivity periods are historic, so the market has moved beyond the main litigation phase.

Any new Paragraph IV filing would likely concern a later-developed formulation or a separate product, not the established Actigall capsule itself.

How strong is the Actigall patent estate?

The patent estate is weak from a present-value perspective.

Patent-estate factor	Assessment
Core molecule	No current protection of commercial value
Brand formulation	Mature and readily substitutable
Clinical indication	Broadly established and vulnerable to generic labeling
Manufacturing process	Potentially protectable in isolation, but not a market barrier for standard ursodiol
Patent litigation leverage	Low
Generic launch risk	Already realized
Lifecycle-management potential	Limited without a new product

A generic manufacturer does not need to reproduce every historical manufacturing process. It must meet FDA requirements for equivalence, quality, and manufacturing compliance. That distinction reduces the practical value of process patents where the marketed product is chemically simple and widely available.

What is the financial trajectory for Actigall?

Actigall’s standalone revenue is not publicly disclosed in the financial reporting of its current or former corporate owners. The product is not generally reported as a separate material revenue line in annual reports. Public filings therefore do not support a precise Actigall revenue figure, unit forecast, or brand-level margin estimate.

The financial trajectory is best characterized as follows:

Financial driver	Expected effect
Generic substitution	Sustained pressure on price and volume
Chronic PBC use	Provides a stable recurring base
Gallstone use	Adds lower-predictability demand
Brand reimbursement	Limits use when generic alternatives are covered
Supply shortages	Can temporarily support branded or alternative-supplier demand
Manufacturing costs	Important because unit prices are low
Promotional spending	Usually uneconomic at broad scale
Patent expiry	Removes premium pricing power
Product withdrawal risk	Relevant if revenue does not cover regulatory and supply costs

Actigall can remain commercially viable as a niche branded product even after generic entry. Brand survival depends on prescription persistence, physician familiarity, wholesaler contracts, pharmacy availability, and the willingness of payers or patients to pay a premium.

The economic model is different from that of a protected specialty drug. Revenue is likely to be stable or declining in nominal terms, while gross margin is pressured by generic substitution, price concessions, manufacturing costs, and distribution fees. A branded supplier may retain value through limited competition in a specific strength or through consistent supply during generic shortages.

How does Actigall compare with generic ursodiol?

Generic ursodiol is the direct substitute and has the strongest competitive position in routine prescribing.

Attribute	Actigall	Generic ursodiol
Active ingredient	Ursodiol	Ursodiol
FDA reference status	Reference listed drug	ANDA-approved equivalents
Price	Usually higher	Usually lower
Clinical differentiation	Limited	Limited
Patient familiarity	Established brand	Variable by manufacturer
Insurance position	Often disadvantaged	Usually preferred
Supply risk	Depends on brand strategy	Varies by supplier
Patent protection	None of material value	No relevant product patent barrier
Commercial outlook	Mature niche	Primary market volume

The brand may retain demand where prescribers specify Actigall, patients request the branded product, or a payer covers it without a significant differential. Those situations do not create a durable competitive moat.

What patent litigation affects Actigall?

No active, high-value patent litigation is known to define the Actigall market. The absence of litigation reflects the age of the product and the lack of a commercially important patent barrier.

Potential legal issues are more likely to involve:

• Generic substitution and pharmacy dispensing.
• Trademark use involving the Actigall name.
• Product liability.
• Manufacturing quality and FDA compliance.
• Supply agreements and distribution rights.
• Pricing or contracting disputes.

These issues can affect operating costs and market access but are not equivalent to patent litigation that delays generic entry.

What generic launch risks exist for Actigall?

Generic launch risk is already embedded in the product’s market position. The principal risks are not future first entry but continued erosion:

1. Further price compression as additional ANDA suppliers enter.
2. Pharmacy substitution away from the brand.
3. Payer exclusion or higher patient copay for Actigall.
4. Loss of shelf space and wholesaler preference.
5. Generic supply normalization after shortages.
6. Reduced physician attention as treatment guidelines emphasize lower-cost options.

A temporary shortage can improve brand demand, but that benefit is unstable. It does not restore exclusivity and can reverse when generic supply recovers.

What manufacturing and intellectual-property barriers exist?

Ursodiol manufacturing is technically regulated but not unusually difficult compared with complex biologics, sterile injectables, or high-potency oncology drugs. The principal barriers are quality-system execution, validated analytical methods, reliable raw-material sourcing, and FDA compliance.

The product does not require:

• Cold-chain distribution.
• A biologic manufacturing platform.
• A specialized delivery device.
• Complex aseptic filling.
• A proprietary diagnostic test.

Manufacturers can therefore compete primarily through scale, procurement, regulatory execution, and supply consistency. The largest operational risk is a shortage or manufacturing disruption, not infringement of a difficult-to-design-around patent.

What licensing deals involve Actigall?

No major current licensing transaction appears to drive Actigall’s value. Historical ownership and marketing rights have changed through broader pharmaceutical portfolio transactions, including the evolution of Actavis and Allergan assets, but Actigall is not generally disclosed as a separately valued strategic asset.

Any licensing value would be limited to:

• Regional distribution.
• Branded-generic commercialization.
• Supply arrangements.
• Portfolio transfers involving multiple products.

The absence of disclosed standalone deal economics supports the conclusion that Actigall is a low-value mature product within a larger pharmaceutical portfolio.

Key Takeaways

• Actigall is the branded form of ursodiol, an established small-molecule drug for PBC and selected gallstones.
• FDA approval dates to the late 1980s, and regulatory exclusivity has expired.
• Generic ursodiol is widely available and is the primary competitive threat.
• The Orange Book reference-drug status does not provide meaningful current patent protection.
• No major active Paragraph IV dispute or patent litigation defines the market.
• Formulation and manufacturing requirements create compliance obligations but not a strong market barrier.
• Standalone Actigall revenue is not publicly disclosed.
• The financial trajectory is mature, low-growth, and exposed to price erosion, payer substitution, and generic supply conditions.
• Any meaningful lifecycle opportunity would require a new formulation, delivery system, or separately protected indication.

Frequently Asked Questions

Is Actigall still under patent?

No material patent protection appears to remain for the established Actigall ursodiol capsule product. Generic competition is already established.

Is ursodiol the same drug as Actigall?

Yes. Actigall is a branded product containing ursodiol. FDA-approved generic ursodiol products are intended to be therapeutically equivalent to the reference product for approved uses.

Does Actigall have FDA exclusivity?

No meaningful FDA exclusivity remains. The product is a mature approved drug with generic equivalents.

Can a generic company launch ursodiol without infringing Actigall patents?

Generic companies have already entered the market. For current launch decisions, applicants must review the applicable Orange Book record, approved labeling, and any later patents associated with specific products or formulations.

Is Actigall a biologic with biosimilar competition?

No. Actigall is a chemically synthesized small-molecule drug. Its competition comes through generic-drug pathways rather than biosimilar applications.

References

1. U.S. Food and Drug Administration. (2023). Actigall (ursodiol) capsules, prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/

2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs, Actigall NDA 020675. https://www.accessdata.fda.gov/scripts/cder/daf/

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

4. U.S. Food and Drug Administration. (n.d.). Generic drug approvals and drug shortages database. https://www.fda.gov/drugs/generic-drugs and https://www.accessdata.fda.gov/scripts/drugshortages/