Last Updated: June 18, 2026

DURICEF Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Duricef patents expire, and what generic alternatives are available?

Duricef is a drug marketed by Warner Chilcott and is included in three NDAs.

The generic ingredient in DURICEF is cefadroxil/cefadroxil hemihydrate. Nineteen suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DURICEF?
  • What are the global sales for DURICEF?
  • What is Average Wholesale Price for DURICEF?
Summary for DURICEF
Recent Clinical Trials for DURICEF

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

SponsorPhase
University of IowaPhase 4
University of Colorado, DenverPhase 1
GlaxoSmithKlinePhase 4

See all DURICEF clinical trials

US Patents and Regulatory Information for DURICEF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott DURICEF cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 050512-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Warner Chilcott DURICEF cefadroxil/cefadroxil hemihydrate FOR SUSPENSION;ORAL 050527-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Warner Chilcott DURICEF cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 050512-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Warner Chilcott DURICEF cefadroxil/cefadroxil hemihydrate FOR SUSPENSION;ORAL 050527-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Warner Chilcott DURICEF cefadroxil/cefadroxil hemihydrate TABLET;ORAL 050528-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Warner Chilcott DURICEF cefadroxil/cefadroxil hemihydrate FOR SUSPENSION;ORAL 050527-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: April 26, 2026

DURICEF (cefadroxil) Market Dynamics and Financial Trajectory

What is DURICEF and how does it sit in the market?

DURICEF is the brand name for cefadroxil, an oral first-generation cephalosporin antibiotic. In the US, DURICEF is a legacy small-molecule antibiotic that has largely moved from branded growth to a generics-led market over time, with pricing and volumes shaped by (1) generic competition, (2) prescriber and guideline preferences, and (3) periodic shortages or supply disruptions at the product level rather than brand-level innovation.

Commercial implication: DURICEF’s market trajectory is typical of older oral antibiotics where brand economics erode quickly once authorized generics and multiple abbreviated new drug applications enter. Financial performance tends to follow a pattern of step-down after generic entry, then stabilization at lower ASPs with any residual brand differentiation driven by contracts, supply reliability, and managed-care formulary positioning.


How do market dynamics affect sales of an older oral antibiotic like DURICEF?

For DURICEF (cefadroxil), the dominant market forces are structural rather than therapeutic novelty:

1) Generic competition and price compression

  • Active ingredient: cefadroxil (genericized).
  • Expected branded economics: declining unit economics after generic entry due to:
    • multiple generic SKUs,
    • wholesale and PBM price referencing,
    • tender-driven purchasing by institutions.

Business effect: ASPs typically compress quickly; brand revenue depends more on formulary access and contract pricing than clinical differentiation.

2) Prescribing behavior and guideline exposure

Cefadroxil competes in primary care and outpatient settings against:

  • other oral cephalosporins (when used),
  • penicillins (e.g., amoxicillin-based regimens),
  • macrolides or doxycycline in selected indications,
  • broad-shift to narrow stewardship choices under antimicrobial resistance (AMR) and stewardship programs.

Business effect: even if cefadroxil remains in formularies, share is contestable and subject to stewardship-driven treatment pathways.

3) Payer controls and formulary tiering

  • DURICEF-like products are typically priced and positioned as therapeutic-class alternatives.
  • Payers often favor lower-cost generics, and DURICEF brand access can deteriorate when cheaper AB-rated competitors widen.

Business effect: revenue becomes sensitive to tier status and annual formulary cycles.

4) Supply stability as a demand lever

Antibiotics can experience:

  • raw-material or manufacturing disruptions,
  • capacity constraints at specific dosage strengths,
  • short-term supply pressure that can move market share.

Business effect: during localized shortages, higher-cost products sometimes retain volume or regain share temporarily, but the effect is usually short-lived.


What is the financial trajectory pattern for DURICEF in a generics-led phase?

DURICEF’s financial trajectory aligns with a legacy branded antibiotic under generic erosion:

Phase 1: Branded peak and early adoption (historical)

  • Brand launched and established in outpatient/community prescribing.
  • Revenue driven by branded recognition and prescriber habit.

Phase 2: Generic entry and market normalization

  • Once generic cefadroxil enters broadly, brand revenue shifts toward:
    • patients captured through existing prescriptions,
    • institutions that still keep branded supply,
    • contract-specific pricing.

Phase 3: Stabilization at lower revenue base

  • Brand revenue often stabilizes at a reduced level.
  • Growth becomes difficult without:
    • new indications,
    • formulation advantages,
    • defensible differentiation, or
    • unusually favorable supply conditions.

Bottom line: DURICEF’s economics are expected to be dominated by pricing and share rather than innovation-led expansion, typical for older oral antibiotics.


What do the product-level facts imply for earnings and cash flows?

DURICEF is not characterized by patent-protected growth in the modern era; cefadroxil is mature. For financial modeling, that means:

Revenue drivers

  • Volume: outpatient prescriptions, influenced by stewardship trends and local competitive dynamics.
  • Net price: pressured by generics and PBM referencing.
  • Mix: depends on strength, formulation, and channel (retail vs mail vs institutional).

Margin drivers

  • Brand margins compress after generic competition.
  • Gross margin is sensitive to:
    • contract price concessions,
    • rebates and chargebacks (PBM dynamics),
    • supply costs and logistics.

Risk factors

  • Substitution to generics is structurally easier than for novel MOAs.
  • Any shortfall in supply affects volume, but also can attract higher-cost replacement purchasing.

How does the competitive set shape DURICEF’s trajectory?

Cefadroxil’s competitive set includes multiple cohorts:

Close antibiotic substitutes

  • oral penicillins and beta-lactam options used for common bacterial infections,
  • other cephalosporins when prescribers keep within the class.

Cost-advantaged alternatives

  • low-cost generics in the same indication areas,
  • stewardship programs that reduce broad usage.

Net effect on market share

  • In stable demand categories, DURICEF competes primarily on price.
  • In shrinking demand categories due to stewardship, DURICEF can lose share even if it retains formulary access.

Does DURICEF face regulatory or safety-driven constraints that impact markets?

As a mature antibiotic, DURICEF’s commercial trajectory is influenced more by:

  • labeling history,
  • adverse event surveillance,
  • and stewardship restrictions, than by newly emerging regulatory barriers (which would be tied to newer modalities or novel safety signals).

Commercial interpretation: regulatory risk tends to be incremental and does not reset the generics-led market structure.


What can investors or R&D planners conclude from DURICEF’s dynamics?

For downstream decision-making, DURICEF functions as a case study in how:

  • genericization erases branded pricing power,
  • therapeutic-class competition and stewardship define volume,
  • and short-term supply events create transient mix effects rather than durable growth.

If the question is about “financial trajectory” rather than market mechanics, the key expectation is a downward step after generic competition, followed by low-growth stabilization tied to formularies and supply reliability.


Key Takeaways

  • DURICEF (cefadroxil) is an older oral antibiotic that operates in a generics-dominated commercial structure, where pricing power is limited.
  • Market dynamics are driven by generic competition, formulary controls, stewardship patterns, and supply stability, not by new clinical differentiation.
  • The financial trajectory typically shows rapid branded revenue erosion after generic entry, then stabilization at a lower revenue base, with any variability driven by contracting, mix, and supply events.
  • Competitive share is contestable within outpatient antibiotic prescribing, making DURICEF a price- and access-sensitive product rather than a growth-led asset.

FAQs

1) Is DURICEF expected to grow versus other oral antibiotics?

Growth is structurally constrained; DURICEF generally tracks outpatient demand plus share, with performance more likely driven by contract/formulary positioning than by new growth drivers.

2) What determines DURICEF net pricing?

Net pricing is primarily determined by PBM referencing, generic substitutes at the same strength/dosage form, and contracting terms that set rebate and chargeback outcomes.

3) Why do legacy antibiotics sometimes hold volume even after generic entry?

Residual volume can persist through formulary access, patient continuity, and localized supply or tender dynamics that temporarily limit lower-cost alternatives.

4) What is the biggest risk to DURICEF revenue?

Sustained substitution to lower-cost generics combined with stewardship and formulary tier changes that reduce brand use.

5) What should R&D teams learn from DURICEF’s market dynamics?

Therapeutic-class participation is not enough to defend economics; durable value requires either differentiation that changes prescribing behavior or IP and access mechanisms that prevent generic displacement.


References

[1] U.S. Food and Drug Administration. Drug Approval Reports and labeling databases for cefadroxil (DURICEF). FDA. (accessed via FDA drug labeling/approval resources).
[2] FDA. National Drug Code (NDC) directory and labeling references for cefadroxil products. U.S. Food and Drug Administration. (accessed via FDA NDC and labeling resources).
[3] IBM Watson Health / Micromedex (secondary industry references used to characterize historical branded vs generic antibiotic market dynamics). (accessed via standard antibiotic market context resources).

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.