PASER Drug Patent Profile

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

Paser is a drug marketed by Adaptis and is included in one NDA.

The generic ingredient in PASER is aminosalicylic acid. There is one drug master file entry for this compound. Additional details are available on the aminosalicylic acid profile page.

Summary for PASER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	110
Patent Applications:	3,645
DailyMed Link:	PASER at DailyMed

US Patents and Regulatory Information for PASER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adaptis	PASER	aminosalicylic acid	GRANULE, DELAYED RELEASE;ORAL	074346-001	Jun 30, 1994		RX	No	Yes

PASER Market Dynamics and Financial Trajectory

Last updated: September 3, 2026

PASER is Jacobus Pharmaceutical Company’s branded formulation of aminosalicylic acid, an oral delayed-release granule used as part of combination therapy for tuberculosis, particularly drug-resistant tuberculosis. Its commercial profile is defined by a small, specialist market, limited competition, public-health procurement, treatment complexity, and the absence of meaningful public financial disclosure from its privately held manufacturer. FDA regulatory exclusivity has expired, but practical generic competition remains limited.

What is PASER and what market does it serve?

PASER contains aminosalicylic acid, also known as para-aminosalicylic acid or PAS. Each packet contains 4 grams of delayed-release granules. Patients mix the granules with an acidic beverage or soft food and swallow them without chewing.

Attribute	PASER
Active ingredient	Aminosalicylic acid
Dosage form	Delayed-release oral granules
Strength	4 g per packet
Manufacturer	Jacobus Pharmaceutical Company, Inc.
FDA application	NDA 050719
Primary use	Combination treatment of tuberculosis
Main clinical niche	Drug-resistant or otherwise difficult-to-treat TB
FDA status	Approved prescription drug
Reference product	PASER
Biosimilar relevance	None; PAS is a small molecule

PASER is not a routine first-line tuberculosis product. Standard drug-susceptible TB treatment generally relies on combinations containing rifampin, isoniazid, pyrazinamide and ethambutol. PAS is used when treatment options are constrained by resistance, intolerance, toxicity, drug interactions or other clinical considerations. The FDA label states that PASER should be administered with other antituberculosis agents and not as monotherapy.[1]

The product’s demand is therefore tied less to total TB incidence than to multidrug-resistant tuberculosis, extensively drug-resistant tuberculosis and treatment programs that retain PAS as a salvage or alternative agent.

When did PASER receive FDA approval and lose exclusivity?

PASER received FDA approval in the early 2000s, with FDA labeling identifying the product’s initial U.S. approval as 2004.[1] Any original regulatory exclusivity associated with that approval has expired.

Milestone	Timing	Commercial effect
U.S. FDA approval	2004	Established PASER as an approved U.S. formulation
Orphan-drug or regulatory exclusivity period, if applicable	Expired	No current exclusivity barrier
Original product patent term	Expired or no longer commercially determinative	Does not prevent ordinary generic development
Current status	Approved marketed product	Continued sales depend on clinical need and supply access

FDA approval does not create perpetual market protection. PASER’s current commercial position depends on product-specific manufacturing knowledge, distribution, procurement relationships and the limited size of the market rather than active FDA exclusivity.

The FDA Orange Book is the relevant source for patents and regulatory exclusivity listed against an approved small-molecule product.[2] PASER does not have a widely recognized current Orange Book patent estate that creates a clear, long-dated barrier to an ANDA applicant. The principal risk is therefore not a large remaining patent cliff. It is the possibility that a generic applicant would face limited commercial returns in a small and operationally difficult market.

What patents protect PASER?

PASER’s protection is primarily associated with its delayed-release formulation and manufacturing process rather than with the aminosalicylic acid molecule itself.

Aminosalicylic acid is an old active pharmaceutical ingredient. Its composition-of-matter protection has long expired. Any historical patent value would have come from the product’s delivery system, including protection of the delayed-release granules, excipient system, stability profile, manufacturing process or dosing presentation.

Formulation and manufacturing protection

PASER’s delayed-release design addresses a central problem with oral PAS: poor tolerability and degradation in the stomach. The granules are designed to release the active ingredient in the intestinal tract. That formulation can create development complexity even when no enforceable patent blocks entry.

Potential generic-development issues include:

• Matching delayed-release performance.
• Demonstrating pharmaceutical equivalence.
• Controlling particle size and granule coating.
• Preserving stability under storage and shipping conditions.
• Reproducing the packet presentation.
• Establishing bioequivalence or satisfying FDA requirements for a product with a complex oral delivery system.
• Maintaining acceptable taste, gastrointestinal tolerability and administration instructions.

A formulation patent can be commercially important only while enforceable. An expired formulation patent may still provide technical information to competitors, but it does not block an ANDA.

How strong is the PASER patent estate?

The PASER patent estate is weak as a current exclusivity platform but may retain practical manufacturing value.

Protection category	Current assessment
Active ingredient patent	No meaningful remaining protection
Core formulation patent	No widely recognized long-term blocking protection
Method-of-use patent	Limited relevance; treatment use is established and combination-based
FDA exclusivity	Expired
Trade secret value	Potentially relevant to granulation, coating, stability and scale-up
Regulatory complexity	Moderate relative to the market size
Overall patent strength	Low for legal exclusion; moderate for know-how and execution

The distinction matters for investors and generic manufacturers. PASER is not protected like a recent specialty drug with active composition, formulation and method-of-use patents. Its defensibility comes from market structure, not a broad patent thicket.

What is the Orange Book status of PASER?

PASER is an approved small-molecule product and is evaluated through the ANDA framework rather than the biosimilar pathway. The Orange Book identifies reference listed drugs, approved products, patent listings and exclusivity information.[2]

Because PASER’s current value does not appear to depend on a significant unexpired Orange Book patent portfolio, an ANDA applicant could potentially pursue a standard generic strategy, subject to FDA requirements and any applicable certifications. A Paragraph IV certification would be relevant only if an unexpired patent were listed against the reference product.

What does a Paragraph IV challenge mean for PASER?

A Paragraph IV filing asserts that a listed patent is invalid, unenforceable or not infringed. For PASER, the commercial significance of such a filing would depend on whether any listed patent remains in force and whether the market can support a challenger.

The Hatch-Waxman framework can provide a 30-month stay of approval when the patent holder timely files infringement litigation after receiving a Paragraph IV notice.[3] That mechanism is less important for PASER than for high-revenue products because:

1. The product’s market is narrow.
2. The manufacturer is private and does not publish product-level revenue.
3. Public-health purchasers can exert price pressure.
4. A generic applicant would need to justify investment in a low-volume product.
5. Technical formulation work may be required even without a blocking patent.

No major, publicly prominent Paragraph IV litigation campaign against PASER is broadly established in the principal FDA and federal litigation sources through mid-2024.

What is PASER’s market size and revenue trajectory?

Public revenue data for PASER are not disclosed in company filings because Jacobus Pharmaceutical Company is privately held. Product-level U.S. sales, gross margin, prescription volume and international revenue are therefore unavailable from standard public-company reporting.

The financial trajectory is best characterized as a mature, low-volume specialty product with relatively stable demand and limited growth potential.

Financial driver	Directional effect
Multidrug-resistant TB incidence	Supports demand
Use of newer all-oral TB regimens	Pressures demand
Public-health procurement	Pressures pricing
Limited competing suppliers	Supports continuity and pricing
Small eligible patient population	Caps revenue
Long treatment duration	Supports volume per patient
Adverse gastrointestinal effects	Limits uptake and persistence
Generic entry	Could reduce price materially
Supply interruption	Could produce temporary pricing leverage

The global TB market is large, but PASER addresses only a narrow segment. WHO treatment guidance has increasingly favored newer, shorter, all-oral regimens for drug-resistant TB, including combinations built around bedaquiline and other modern agents.[4] That trend reduces the role of older second-line agents such as PAS, although PAS remains relevant when patients cannot use preferred alternatives or when resistance patterns narrow treatment choices.

A patient receiving 4 grams three times daily may use three 4-gram packets per day. A prolonged treatment course can therefore generate substantial product volume per patient even when the total treated population is small. Commercial demand is concentrated among specialized TB centers, public-health departments, hospitals, prisons, military systems and international procurement programs.

Which companies compete with PASER?

PASER competes with therapeutic alternatives more than with directly substitutable U.S. branded products.

Direct and near-direct competition

• Other aminosalicylic acid or para-aminosalicylic acid products.
• Compounded or locally manufactured PAS formulations in some jurisdictions.
• Older second-line agents such as cycloserine, linezolid and injectable or oral alternatives, depending on resistance and tolerability.
• Newer drug-resistant TB regimens containing bedaquiline, pretomanid, delamanid, linezolid and related agents.

The competitive threat from newer therapies is clinically stronger than the threat from branded direct substitutes. Regimens that are shorter, better tolerated or easier to administer can displace PAS even without a generic PASER launch.

What generic entry risks exist for PASER?

Generic entry is legally feasible but commercially uncertain.

Generic launch scenarios

Scenario	Likely market effect
No generic entrant	Jacobus retains a specialized supply position; volume remains limited
One approved generic	Price pressure increases, but supply may remain concentrated
Multiple generics	Greater discounting and potential contracting competition
Compounded alternatives	Local price pressure, with variable regulatory status
Newer TB regimens continue expanding	Structural erosion in PAS demand

A generic applicant may pursue an ANDA referencing PASER as the reference listed drug. The key barriers would likely be formulation replication, FDA development economics and procurement access, not a major remaining patent portfolio.

A first generic could obtain 180-day exclusivity if it is the first applicant to submit a substantially complete ANDA with a paragraph IV certification and otherwise qualifies under the statute.[3] That opportunity would have value only if the market supports the development and launch investment.

What is the regulatory status of PASER?

PASER remains an FDA-approved prescription product for use with other antituberculosis agents in adults and children six years of age and older, according to FDA labeling.[1]

The label includes clinically important warnings relating to gastrointestinal intolerance, hypersensitivity and laboratory monitoring. PASER is administered orally, which avoids the injection burden associated with some historical second-line TB therapies, but its administration requirements and tolerability remain commercial limitations.

FDA and public-health considerations

FDA status supports continued U.S. procurement, but it does not guarantee broad utilization. Treatment guidelines from CDC, WHO and national TB programs influence demand. Public-sector purchasers often prioritize regimen effectiveness, treatment duration, safety, resistance management and total treatment cost over brand preference.[4,5]

What litigation and settlement agreements affect PASER?

No high-profile patent litigation or settlement agreement is broadly associated with PASER through mid-2024. The product does not appear to have generated the type of recurring Hatch-Waxman litigation seen with high-revenue chronic medicines.

The absence of visible litigation is consistent with an expired or limited patent estate and a market that may not justify aggressive generic litigation. It does not eliminate the possibility of future ANDA disputes if a patent is listed or if a generic applicant challenges formulation-related rights.

How does PASER compare with newer drug-resistant TB therapies?

Factor	PASER	Newer all-oral TB regimens
Clinical role	Alternative or salvage agent	Increasingly preferred for eligible patients
Dosage burden	Three-times-daily administration commonly used	Often simpler, regimen-dependent
Tolerability	Gastrointestinal adverse effects can limit use	Varies by regimen
Patent position	Mature, weak current exclusivity	Some products retain active patent protection
Market growth	Limited	Supported by guideline adoption and program investment
Commercial risk	Generic substitution and clinical displacement	Patent expiry, safety and reimbursement risk
Procurement	Specialist and public-health channels	Broader strategic importance in resistant TB programs

PASER’s future is tied to patients who need an older, established option. Newer regimens will likely continue to reduce routine use, but resistance, contraindications, drug interactions and access limitations can preserve a residual market.

What is the geographic coverage and international opportunity?

PASER has its clearest regulatory and commercial identity in the United States. International demand depends on country-specific registration, national TB guidelines, procurement tenders and Global Drug Facility or similar purchasing channels.

The global opportunity is constrained by:

• National preference for WHO-recommended regimens.
• Price-sensitive public procurement.
• Local registration requirements.
• Availability of alternative PAS products.
• Limited willingness to pay for an older active ingredient.
• Need for reliable supply during complex, long-duration treatment.

The strongest international demand is likely to arise where drug-resistant TB programs require additional regimen options and where newer medicines are unavailable, contraindicated or unaffordable.

What manufacturing and intellectual-property barriers affect PASER?

The most important barrier is technical execution. A competitor must produce a stable delayed-release granule with consistent release characteristics and acceptable shelf life. The active ingredient itself is not difficult to conceptualize, but the finished dosage form is more demanding than an immediate-release tablet or capsule.

Potential manufacturing risks include coating uniformity, moisture control, packaging integrity, dissolution testing and scale-up reproducibility. These factors can delay approval or create post-launch supply problems.

Trade secrets and manufacturing know-how can therefore extend practical defensibility beyond the legal patent term. That protection is weaker than a patent because it does not prevent independent development and can be overcome through reverse engineering and regulatory testing.

Key Takeaways

• PASER is a mature, FDA-approved delayed-release aminosalicylic acid product marketed by privately held Jacobus Pharmaceutical Company.
• Its market is narrow and concentrated in drug-resistant or difficult-to-treat tuberculosis.
• FDA exclusivity and any meaningful original patent protection have expired.
• The current patent estate appears weak as a legal barrier to generic entry.
• Formulation, manufacturing and supply reliability remain more important than composition-of-matter IP.
• No major public Paragraph IV litigation or settlement agreement is broadly associated with PASER through mid-2024.
• Newer all-oral TB regimens create the principal long-term commercial threat.
• Product-level revenue, margin and volume data are not publicly disclosed.
• Generic entry is feasible but may be unattractive because of the small market and specialized procurement channels.
• PASER is likely to remain a niche, strategically useful product rather than a high-growth pharmaceutical asset.

FAQs

Is PASER a first-line tuberculosis drug?

No. PASER is generally used with other agents when resistance, intolerance or other clinical factors limit preferred TB treatment options.

Is aminosalicylic acid still patented?

The active ingredient is an old compound and has no meaningful modern composition-of-matter exclusivity. Any relevant protection would concern formulation or manufacturing.

Can a generic company file an ANDA for PASER?

Yes, in principle. The applicant would need to satisfy FDA requirements for the delayed-release formulation and address any applicable listed patents or exclusivity.

Does PASER have biosimilar competition?

No. PAS is a small-molecule drug regulated through the generic-drug framework, not the biologics and biosimilars pathway.

Is PASER revenue publicly reported?

No. Jacobus is privately held and does not provide public-company product-level revenue disclosures for PASER.

References

1. U.S. Food and Drug Administration. (2023). PASER (aminosalicylic acid) delayed-release granules prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Congress. (1984). Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417.
4. World Health Organization. (2022). WHO consolidated guidelines on tuberculosis: Module 4, treatment: Drug-resistant tuberculosis treatment.
5. Centers for Disease Control and Prevention. (2024). Treatment for drug-resistant tuberculosis disease.