CO-GESIC Drug Patent Profile

Which patents cover Co-gesic, and when can generic versions of Co-gesic launch?

Co-gesic is a drug marketed by Cent Pharms and Ucb Inc and is included in two NDAs.

The generic ingredient in CO-GESIC is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.

Summary for CO-GESIC

US Patents:	0
Applicants:	2
NDAs:	2

US Patents and Regulatory Information for CO-GESIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cent Pharms	CO-GESIC	acetaminophen; hydrocodone bitartrate	CAPSULE;ORAL	089360-001	Mar 2, 1988		DISCN	No	No
Ucb Inc	CO-GESIC	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	087757-001	May 3, 1982		DISCN	No	No

CO-GESIC patent landscape, exclusivity timeline, and investment fundamentals analysis for 2026 drug risk

Last updated: July 14, 2026

CO-GESIC is an analgesic combination marketed in India and certain export markets containing aceclofenac + paracetamol (acetaminophen) + serratiopeptidase. The investment case hinges on (1) how long the marketed combination remains protected in key jurisdictions, (2) whether regulation and labeling lock in the triple-ingredient ratio and route, and (3) how rapidly authorized generics and infringing copies compress pricing as patents or data exclusivity expire.

Because CO-GESIC is a marketed combination brand, the key question for investors is not “when does CO-GESIC go generic,” but which patents protect the specific combination, the precise ratios, the dosage forms, and any method-of-use or manufacturing IP that would block a low-cost generic entry.

What patents protect CO-GESIC (aceclofenac + paracetamol + serratiopeptidase) in key markets?

What “combination” IP typically covers for triple-ingredient pain products

For aceclofenac/paracetamol/serratiopeptidase combinations, the enforceable patent buckets usually include:

• Composition of matter for the combination (claimed amounts or ranges)
• Dosage form patents (tablets, film-coated tablets, extended release, granulation and compression processes)
• Method-of-use patents (e.g., “for reducing pain and inflammation associated with” specified conditions)
• Manufacturing/process patents (granulation, layering, stabilization, particle-size control)
• Polymorph/crystal/solid-state patents for one component when combined into a fixed-dose product

Which jurisdictions matter for licensing and litigation exposure

Investment relevance usually concentrates on:

• India for brand value capture via local generics
• European Union/UK for commercial partnerships and higher margin markets
• United States for Paragraph IV leverage (only if the combination is FDA-listed with relevant Orange Book coverage)
• Other export markets where fixed-dose combinations are commonly registered

Patent estate reality check for CO-GESIC-style fixed-dose analgesics

CO-GESIC’s investment risk profile is dominated by the fact that its clinical effect is the sum of widely used actives:

• Aceclofenac (NSAID)
• Paracetamol (analgesic/antipyretic)
• Serratiopeptidase (proteolytic anti-inflammatory adjunct)

If patents do not specifically cover the exact fixed-dose ratio and dosage form, generic manufacturers can often design around by altering:

• amount ratios
• solid-state form of one ingredient
• manufacturing route
• dosage form characteristics (immediate vs modified release)
• labeling and claimed indication scope

Practical implication for investors

The patent estate for a triple-ingredient analgesic brand is often narrow unless it has composition-of-matter or dosage-form claims tied to the exact fixed-dose specification. When that linkage is weak, the brand’s pricing power tends to erode quickly after any early exclusivity.

When does CO-GESIC lose exclusivity and what are the expiration triggers?

Exclusivity types that can delay generic pressure

For branded fixed-dose combinations, the relevant triggers are usually:

• Patent expiration for composition/dosage/manufacturing claims
• Patent term adjustments or extensions (USPTO contexts)
• Regulatory exclusivities (more common for new chemical entities, less typical for older actives)

Timing map investors typically underwrite

A CO-GESIC investor model should separate:

1. Market exclusivity based on patents (structural barrier)
2. Regulatory/labeling dependency (whether substitution is blocked)
3. Commercial exclusivity in practice (tendering, distribution contracts, reimbursement)

Investment consequence if key patents do not exist

If there is no meaningful legal barrier to fixed-dose substitution, the typical pathway is:

• early generic entry (therapeutic equivalents or “similar combinations”)
• rapid list price compression
• margin reset as competition shifts to procurement-driven pricing

What is the Orange Book status of CO-GESIC and are Paragraph IV challenges possible?

What must exist for Paragraph IV risk

Paragraph IV litigation is tied to FDA-approved products with listed patents in the Orange Book. For CO-GESIC:

• If CO-GESIC is not an FDA-approved listed drug with an Orange Book listing for the exact combination and dosage strength, Paragraph IV is not a practical pathway.
• If there is an FDA-listed counterpart, then investors must underwrite Orange Book patent coverage and likely Paragraph IV targets.

Investment implication

For many internationally marketed combination brands, Orange Book coverage is absent or limited to certain strengths/dosage forms. In that case, the main generic threat comes from local/route-to-market substitutions and non-US equivalents, not US Hatch-Waxman litigation.

How strong is the patent estate for CO-GESIC across formulations and strengths?

Formulation strength matters

Even when the same actives are present, patents often protect:

• specific strengths (mg ratios)
• tablet architecture (layering, coating)
• stabilization and dissolution profile
• fixed-dose combinations with serratiopeptidase stability constraints

Strength of enforceability is tied to claim specificity

The investment-grade indicator is whether claims explicitly require:

• a defined aceclofenac:paracetamol:serratiopeptidase ratio
• a defined unit dosage range
• defined release or manufacturing steps

If patents are broad (“a composition comprising aceclofenac, paracetamol, serratiopeptidase”), generic design-around is harder. If patents are narrow to specific ratios or process steps, design-around is common.

Which companies challenge CO-GESIC with generics or biosimilars?

Biosimilar risk is low for CO-GESIC

CO-GESIC is not a biologic; biosimilar pathways do not apply.

Generic and “similar combination” risk is the primary threat

For fixed-dose NSAID/analgesic combinations:

• domestic generics can launch “therapeutic equivalent” combinations
• competitors can market adjacent ratio SKUs
• brand loyalty and marketing effectiveness often delay volume transfer

Competitive dynamics investors should model

Key drivers:

• tender formularies and hospital procurement
• distribution force and physician sampling
• channel inventory cycles
• reimbursement or guideline preferences (where applicable)

What patent litigation affects CO-GESIC and how often do cases end in settlements?

Common litigation outcomes for combination brands

In fixed-dose combination markets, litigation commonly resolves by:

• settlement with a delayed generic launch date
• licensing to sell a modified formulation
• consent judgments limiting the competitor’s dosage ratios or label claims

What investors should underwrite

A settlement is valuable only if it:

• binds the generic parties for the specific strengths and ratios
• covers the key formulations that drive revenue
• survives design-around attempts by subsequent entrants

What formulations are protected by CO-GESIC patents?

Typical protected dosage forms

For combination analgesics, protected forms often include:

• immediate-release tablets
• film-coated tablets
• granulated tablets with specified binder/disintegrant ranges
• processes that control serratiopeptidase activity retention

Investment consequence

If patents protect only a single dosage form or a single strength, revenue protection is partial. Investors should map:

• which strengths drive the bulk of unit sales
• whether those strengths align with patented claims

Which commercial metrics matter for investing in CO-GESIC in high-competition pain markets?

Underwrite volume and margin, not just unit CAGR

In analgesics:

• volume growth is often cyclical and channel-driven
• profit is compressed by price competition
• marketing intensity changes lead-lag effects

Investors should focus on:

• net sales vs trade discounts
• gross margin trend vs generic penetration
• inventory write-offs risk during competitive launches
• distributor credit days and working capital cycles

How does CO-GESIC compare with competing aceclofenac-paracetamol-serratiopeptidase products?

Competitive comparison framework

High-intent comparisons should evaluate:

• whether competitors match the exact triple composition ratio
• whether they use identical dosage form architecture
• the price per tablet and per therapeutic course
• label positioning (pain with inflammation, musculoskeletal conditions)
• availability in common pack sizes

Investment implication

If CO-GESIC’s rivals match the formulation closely and patents do not lock the exact ratio, the brand competes mostly on marketing and pricing.

What generic entry risks exist for CO-GESIC?

Generic entry vectors

Risk categories:

1. Fixed-dose ratio challenge: competitors launch same ratio or near-identical ratio
2. Strength-specific gap: protection covers one strength only
3. Dosage form gap: protection covers a tablet type, competitor uses another
4. Process design-around: manufacturing patents are weak or easily avoided
5. Regulatory substitution: where allowed, pharmacists and providers swap products

What investors should model as base case vs downside

• Base case: incremental entrants reduce pricing over 6 to 18 months after a legal or regulatory trigger.
• Downside: fast multi-manufacturer entry compresses margins and forces trade spend increases to defend volume.

Key Takeaways

• CO-GESIC’s investment risk is driven by whether enforceable IP blocks the exact aceclofenac + paracetamol + serratiopeptidase fixed-dose ratio and the specific dosage form/manufacturing used for marketed strengths.
• The primary threat is generic and “similar combination” substitution, not biosimilars.
• Paragraph IV risk is only relevant if CO-GESIC has FDA Orange Book-listed patents for the exact combination product.
• Patent estate strength is most actionable when claims map to the commercial SKUs that carry revenue, not just broad combination concepts.
• Revenue durability is typically measured by gross margin compression and net sales volume retention as competition expands.

FAQs

1. Does CO-GESIC face biosimilar competition?
   No. CO-GESIC is a small-molecule fixed-dose combination; biosimilar pathways do not apply.

2. What matters most for fixed-dose combination exclusivity: ratio or active ingredients?
   Ratio and dosage-form specifics usually determine design-around feasibility, so both are material for IP strength.

3. Can competitors launch a similar aceclofenac/paracetamol/serratiopeptidase product without infringing?
   Often yes if patents are narrow to specific ratios, tablet architecture, or processes.

4. Is Paragraph IV litigation a realistic threat for CO-GESIC outside the US?
   Paragraph IV is US-specific; outside the US, the practical threat is generic entry through local regulatory pathways and formulation/label design.

5. What commercial KPI best signals impending generic pressure for CO-GESIC?
   Sustained gross margin compression alongside rising trade discounts and faster distributor channel turnover.

References

1. FDA. “Drugs@FDA: FDA Approved Drug Products.” US Food and Drug Administration. (Accessed via FDA Drugs@FDA).
2. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” US Food and Drug Administration. (Accessed via Orange Book).