IBU-TAB 200 Drug Patent Profile

When do Ibu-tab 200 patents expire, and what generic alternatives are available?

Ibu-tab 200 is a drug marketed by Alra and is included in one NDA.

The generic ingredient in IBU-TAB 200 is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-nine suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ibu-tab 200

A generic version of IBU-TAB 200 was approved as ibuprofen by CONTRACT PHARMACAL on October 15^th, 1986.

Summary for IBU-TAB 200

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for IBU-TAB 200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alra	IBU-TAB 200	ibuprofen	TABLET;ORAL	071057-001	Aug 11, 1988		DISCN	No	No

Last updated: July 11, 2026

IBU-TAB 200 (ibuprofen) Investment Scenario and Fundamentals Analysis: Exclusivity, Patent Landscape, and Generic/Biosimilar Risk

IBU-TAB 200 is a 200 mg ibuprofen tablet product. Investment fundamentals hinge on whether this specific brand has differentiation tied to formulation, manufacturing, or label claims, versus functioning as a straightforward branded generic. For ibuprofen 200 mg, the economic base case typically assumes high regulatory substitutability, price erosion, and limited incremental patent leverage unless IBU-TAB 200 is tied to a still-active secondary IP layer (fixed-dose combinations, special polymorphs/solvates, extended-release mechanics, or method-of-use claims).

Because the prompt provides no jurisdiction, NDA/ANDA pathway, marketing authorization details, manufacturer, or Orange Book/Boldd status for IBU-TAB 200, a complete patent-and-regulatory fundamentals assessment cannot be produced to a standard suitable for investment or litigation decisions.

What patents protect IBU-TAB 200 (ibuprofen 200 mg) and who owns them?

A complete mapping of patents that protect IBU-TAB 200 requires at least one of the following: the referenced active ingredient NDA/ANDA, the listed FDA application number for the exact product strength, the Orange Book “drug product” listing tied to “IBU-TAB 200,” or the owning marketing authorization holder and dossier identifiers. Without those identifiers, any patent list would be speculative.

How many patents cover ibuprofen 200 mg tablets vs brand-specific IP layers?

For established OTC and widely genericized ibuprofen products, the patent estate is usually dominated by early-generation active-ingredient coverage that has largely expired, leaving the remaining enforceable IP to:

• specific formulations (polymorph/solid-state form)
• controlled release or gastro-resistant delivery designs
• fixed-dose combinations (for example, ibuprofen plus a second active)
• manufacturing/process constraints
• restricted method-of-use or dosing regimens (rare for immediate-release OTC-equivalent strengths)

A fact-based answer requires the exact IBU-TAB 200 dossier mapping.

Which companies are challenging ibuprofen 200 mg tablet brands with Paragraph IV?

Paragraph IV challenges presuppose an FDA ANDA with a specific Orange Book reference product. Without the Orange Book reference product ID and ANDA litigation dockets tied to IBU-TAB 200, the challenge landscape cannot be enumerated.

When does IBU-TAB 200 lose exclusivity, and what exclusivity types matter?

For ibuprofen 200 mg, exclusivity is typically not a durable investment pillar for a standalone immediate-release tablet brand, because:

• composition-of-matter patents for ibuprofen have long lapsed, in most markets
• orphan exclusivity is inapplicable unless the product has an orphan indication
• pediatric exclusivity depends on eligible regulatory triggers
• new clinical-investigation exclusivity is product-specific and requires an active new drug application for that product form

A credible exclusivity timeline depends on the exact regulatory authorization and its exclusivity grants.

What is the Orange Book status of IBU-TAB 200 (listed drug, patent numbers, exclusivity end dates)?

Orange Book status requires the drug’s FDA application number and its listed-drug record. Without it, a precise table of:

• listed drug name
• application number
• patent numbers
• patent expiration dates by patent type
• exclusivity expiration dates
  cannot be produced.

How strong is the patent estate for ibuprofen 200 mg tablets, and where does enforceability usually fail?

If IBU-TAB 200 is an immediate-release ibuprofen tablet without special delivery, enforceability typically concentrates in:

• narrow formulation claims
• narrow process claims
• secondary patents tied to specific excipients, granulation routes, or solid-state forms

These are often vulnerable to design-arounds and generic substitution because regulators do not require generic to copy nonessential formulation details if bioequivalence is met.

A strength assessment also depends on the litigation and claim construction history, which is unavailable without product-specific patent identification.

What generic entry risks exist for IBU-TAB 200, and how fast would price erosion occur?

For a 200 mg immediate-release ibuprofen tablet, generic entry risk is usually high absent live brand-specific IP. Market behavior for plain ibuprofen strengths generally shows:

• rapid substitution after approval
• pricing compression within months of meaningful generic penetration
• switching driven by pharmacy stocking, insurer formulary tiers, and OTC habits

A defensible risk model requires:

• whether IBU-TAB 200 is Rx or OTC in the target market
• reimbursement sensitivity and formulary positioning
• local regulatory review timelines and bioequivalence requirements
• tender and procurement dynamics

Those details are not provided.

What formulation patents could protect IBU-TAB 200 if it is differentiated?

Formulation-level differentiation for a “200 mg tablet” usually falls into one of these buckets:

• controlled release or sustained release (not implied by “IBU-TAB 200”)
• specific ibuprofen solid-state form (polymorph/solvate/hydrate)
• fixed-dose combination tablet design (not implied)
• taste-masking, enteric coating, or permeability modifications

Without the product label, dosage form description, or application reference, the formulation patent question cannot be answered factually.

What method-of-use or dosing patents could apply to IBU-TAB 200?

Method-of-use patents can exist where an indication is narrow and clinical evidence is new. For ibuprofen 200 mg tablets, method-of-use IP is uncommon because the drug’s use is broadly established. Still, product-specific claims could exist for dosing regimens tied to pediatric, migraine, or specific pain models.

A method-of-use assessment requires the exact indicated claims and any related patent claims in the relevant jurisdiction.

What FDA regulatory status applies to IBU-TAB 200 (NDA, ANDA, OTC monograph, or marketing authorization)?

A fundamentals analysis needs the regulatory pathway:

• NDA for an innovator drug
• ANDA referencing an existing listed drug
• OTC monograph status (for OTC equivalents in the US, if applicable)
• non-US marketing authorization route (EMA, MHRA, etc.)

No regulatory status is supplied, so the regulatory risk and timelines cannot be mapped.

How does IBU-TAB 200 compare with other ibuprofen 200 mg brands on IP and market exposure?

Comparable analysis would normally cover:

• patent estates by brand
• whether each is Rx/OTC
• number of approved generics and market share
• payer positioning and tender outcomes

No brand roster, manufacturer list, or target geography is provided, so the comparison cannot be executed without introducing unverified claims.

What patent litigation affects ibuprofen tablet brands like IBU-TAB 200?

Patent litigation is case- and jurisdiction-specific. To identify litigation affecting IBU-TAB 200, the analysis must include:

• relevant patents in suit
• defendant ANDA applicants (Paragraph IV) or enforcement actions
• settlement terms and launch dates
• district court, CAFC posture, and injunction status

No product-specific litigation identifiers are provided.

Commercial fundamentals: what drives revenue, margins, and cash flow for IBU-TAB 200?

For plain ibuprofen 200 mg tablets, fundamentals typically depend on:

• unit demand stability (pain, fever indications; seasonal peaks in some markets)
• gross margin after generic competition
• distribution channel mix (wholesale, retail pharmacy, e-commerce, institutional)
• procurement/tender pricing and rebate structures
• working capital due to fast inventory turnover

A quant model requires baseline revenue, pricing, competitor count, and channel data that are not included.

Investment scenario base case: what is the most likely outcome for a 200 mg ibuprofen tablet brand?

Given missing product-specific IP and regulatory identifiers, the base case for a 200 mg immediate-release tablet brand is:

• limited durable patent exclusivity
• increased generic substitution pressure
• margin compression over time
• valuation tied to distribution strength and execution rather than long-term patent payoffs

A scenario analysis with dates, legal triggers, and probability-weighted timelines cannot be produced without the Orange Book record, authorized dossier, or patent list tied to IBU-TAB 200.

Key Takeaways

• A fact-based exclusivity, patent, and litigation fundamentals assessment for IBU-TAB 200 cannot be produced without the product’s regulatory identifiers (FDA listed-drug record or non-US dossier references) that link the brand to patents and exclusivity grants.
• For an immediate-release 200 mg ibuprofen tablet, investment upside usually depends on brand-specific, still-active secondary IP or unusually strong distribution/payer positioning rather than core active-ingredient exclusivity.
• Generic entry risk is typically high for plain strength/rapid substitute dosage forms unless tied to a differentiated formulation or combination.

FAQs

1. Is ibuprofen 200 mg tablet typically protected by active-ingredient patents in the US or EU?
2. Does a branded ibuprofen tablet earn meaningful FDA exclusivity if it is reformulated without a new active ingredient?
3. How do Paragraph IV challenges affect ibuprofen tablet brand revenues when multiple generics are already approved?
4. What commercial levers matter most for a low-differentiation NSAID tablet compared with a controlled-release product?
5. How can formulation differentiation (solid-state form or excipients) translate into defensible patent claims for generic barriers?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
2. FDA. Application Integrity Policy and ANDA approval framework (general ANDA principles).