CARAC Drug Patent Profile

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

Carac is a drug marketed by Extrovis and is included in one NDA.

The generic ingredient in CARAC is fluorouracil. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Carac

A generic version of CARAC was approved as fluorouracil by FRESENIUS KABI USA on September 30^th, 1998.

Summary for CARAC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Patent Applications:	4,353
Drug Prices:	Drug price information for CARAC
What excipients (inactive ingredients) are in CARAC?	CARAC excipients list
DailyMed Link:	CARAC at DailyMed

See drug prices for CARAC

See drug sales revenues for CARAC

Paragraph IV (Patent) Challenges for CARAC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARAC	Cream	fluorouracil	0.5%	020985	1	2011-07-29

US Patents and Regulatory Information for CARAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000		RX	Yes	Yes

Expired US Patents for CARAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000	4,690,825
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000	6,670,335

International Patents for CARAC

See the table below for patents covering CARAC around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	68965
Australia	591264
Australia	7132287
Germany	3774266

CARAC (carbenicillin?) market dynamics and financial trajectory: revenue, pricing, exclusivity, and generic risk

Last updated: June 15, 2026

What is CARAC and what market segment does it serve?

CARAC is a branded antibacterial drug product in the US market. It is marketed for dermatologic use (commonly referenced in product listings as a topical carboxylic acid/antibacterial-type regimen rather than an oncology biologic). CARAC is typically discussed in the context of dermatology prescribing and outpatient pharmacy demand rather than hospital-administered specialty care.

Core market dynamic: CARAC competes primarily on (1) formulary access by payors and (2) the availability and substitution of therapeutically equivalent topical antibacterials and keratolytic/antibiotic alternatives.

Where does CARAC sit in the competitive landscape?

CARAC’s demand profile is shaped by:

• Dermatology physician and primary-care prescribing volume
• Pharmacy benefit manager (PBM) formulary placement
• Patient out-of-pocket cost at the pharmacy counter
• Substitution pressure once generics or lower-cost equivalents are available

How has CARAC revenue trended and what drives year-over-year financial movement?

CARAC’s financial trajectory is driven by a standard set of commercialization variables for older small-molecule branded dermatology products:

• Net price after rebates and discounts (PBM-driven)
• Script volume (prescriber adoption and retention)
• Channel mix (retail vs mail order)
• Share erosion from therapeutically adjacent products
• Product lifecycle phase (maturity, then decline after generic entry)

Key dynamic for mature brands: Revenue often declines even when units are stable because net pricing compresses through rebate renegotiations and competition.

What are the main revenue levers for CARAC?

• Price realization: Discounting intensifies when competing products gain formulary coverage.
• Volume: New prescriber pull-through is limited once a product is established; growth typically comes from formulary wins or expanded indications, if any.
• Gross-to-net: Rebates rise as PBM leverage increases.
• Inventory and supply: Shortages or relabeling can distort short-term sales.

When does CARAC lose exclusivity and how does that affect the financial path?

CARAC’s forward financial trajectory is determined by the interaction of:

• Patent expiration (composition, formulation, method of use, and packaging)
• Regulatory exclusivities (if applicable, such as specific New Chemical Entity exclusivity)
• Generic entry timelines driven by FDA approvals and Paragraph IV litigation settlements (if any)

Featured snippet answer: Financial decline pressure typically accelerates after the first approved generic or authorized equivalent reaches the market and gains meaningful PBM and pharmacy conversion.

What patent events typically govern generic entry timing?

For topical prescription products, the practical entry timeline often depends on:

• Composition and salt/form variants
• Formulation and concentration-specific protection
• Manufacturing process protection
• Method-of-use protection (when claims are tied to a clinical regimen)

What patents protect CARAC and how strong is the patent estate?

A CARAC patent estate assessment requires an Orange Book and patent-family view (listed patents, claim scopes, expiration dates, and any active litigation). Without reliable, verifiable CARAC-specific patent and Orange Book records in the provided material, a complete and accurate patent landscape cannot be produced.

What is the Orange Book status of CARAC and which listings matter for generics?

Orange Book status controls:

• Whether the product is listed as a brand with patent protection
• The set of listed patents that an applicant must address for FDA approval
• The presence of exclusivity blocks that delay generic approvals

Without verified Orange Book listing data for CARAC, an Orange Book status statement and generics-readiness score cannot be generated.

What generic entry risks exist for CARAC under Paragraph IV?

Paragraph IV risk depends on:

• Existence of orange-book-listed patents that can be challenged
• Whether there is known litigation (filed ANDA, complaint, court docket)
• Settlement and triggering-event terms (automatic approval dates or launch covenants)

Without Paragraph IV and litigation records for CARAC, generic entry timing and risk quantification cannot be stated.

How many patents cover CARAC formulations, and what delivery/strength constraints matter?

For topical products, formulation and strength are common bottlenecks:

• Concentration-specific formulation protection
• Vehicle and excipient-specific claims
• Stabilization, penetration enhancers, and antimicrobial preservation claims

Without CARAC formulation patent listings and claim-coverage details, the count and practical constraint level cannot be provided.

What patent litigation affects CARAC and how does it change market timing?

Patent litigation can:

• Delay FDA approval/launch via automatic stay (if Paragraph IV and conditions are met)
• Shift market shares if the brand wins and preserves formulary access
• Speed up entry if the brand loses or settles with an at-risk launch date

Without verified CARAC litigation dockets, any statement about case status would be incomplete.

What settlements or licensing deals impact CARAC launch calendars?

Brand licensing or settlement agreements typically define:

• Authorized generic supply windows
• Launch design-arounds (different strength, formulation, labeling)
• Timing of market entry and exclusivity carveouts

No CARAC-specific settlement terms are provided, so a deal-driven calendar cannot be constructed.

What is the FDA regulatory status of CARAC and what is its approval pathway?

Financial trajectory is affected by regulatory pathway because it correlates with:

• Time to first generic approval
• Ease of bioequivalence or formulation bridging
• Potential for additional branded line extensions

A complete, CARAC-specific regulatory status requires:

• FDA labeling version and approval history
• Orange Book application type and applicant details

How does CARAC compare with competing dermatology antibiotics and antibacterials on cost and access?

CARAC’s market dynamics typically hinge on cost and formulary standing versus:

• Lower-priced therapeutically equivalent topicals
• Combination products that win clinical preference
• OTC switchability (where applicable, if any comparable products are not prescription-bound)

A precise comparative landscape requires competitor-specific pricing, formulary tiers, and substitution patterns, which are not included in the provided material.

What commercial outcomes are most likely for CARAC over the next 3–7 years?

For mature branded topicals, the most common pattern is:

• Continued baseline sales for a period, then
• Step-down after first generic/authorized equivalent penetration and PBM tier movement
• Margin compression driven by net pricing erosion

A credible 3–7 year forecast requires CARAC’s current revenue base, net price trajectory, and explicit patent and generic timelines, none of which are available in the provided input.

Key Takeaways

• CARAC’s financial trajectory in dermatology is primarily driven by net price compression, script volume, and formulary access.
• The biggest inflection risk is generic or authorized-equivalent entry after patent and regulatory barriers fall.
• A complete patent-and-Orange-Book-based exclusivity and launch calendar cannot be produced from the provided information, so litigation- and settlement-driven timing cannot be quantified.
• Accurate revenue trend and forecast require verified CARAC financial disclosures and confirmed FDA/Orange Book records.

FAQs

1. What factors determine whether CARAC gets preferred formulary status versus competing topical antibacterials?
2. How does PBM rebate pressure typically change net sales for mature branded topical prescription drugs like CARAC?
3. What launch events usually cause the sharpest revenue decline for branded dermatology products?
4. How do formulation differences (vehicle, concentration, excipients) affect generic substitution for topical dermatology drugs?
5. How do Paragraph IV automatic stays and court settlements influence the first generic launch timing for established brands?

References

No sources were provided in the input, and no verifiable CARAC-specific Orange Book, FDA, litigation, or financial disclosure material is included, so citations cannot be generated.

DrugChatter Q&A for CARAC

How does Carac treat actinic keratosis?