Last Updated: August 8, 2026

SANSAC Drug Patent Profile


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When do Sansac patents expire, and when can generic versions of Sansac launch?

Sansac is a drug marketed by Dow Pharm and is included in one NDA.

The generic ingredient in SANSAC is erythromycin. There are one hundred and three drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the erythromycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sansac

A generic version of SANSAC was approved as erythromycin by TORRENT on July 6th, 2020.

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Questions you can ask:
  • What is the 5 year forecast for SANSAC?
  • What are the global sales for SANSAC?
  • What is Average Wholesale Price for SANSAC?
Summary for SANSAC
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,334
DailyMed Link:SANSAC at DailyMed

US Patents and Regulatory Information for SANSAC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dow Pharm SANSAC erythromycin SOLUTION;TOPICAL 062522-001 Jan 24, 1985 DISCN No 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: July 11, 2026

SANSAC drug market dynamics and financial trajectory: sales trends, pricing, exclusivity, and competitive pressure

SANSAC is a brand name used for anti-infective/antiprotozoal therapy in some markets, but it is not a unique U.S. FDA drug-name identifier in a way that supports an Orange Book, exclusivity, or revenue-trajectory build without risking incorrect mapping to an active ingredient. With no reliable linkage to an FDA-listed active ingredient, dosage form, or marketing authorization record, a defensible analysis of market size, payer dynamics, sales, price trajectory, and patent-driven competitive timing cannot be produced.

What is SANSAC’s active ingredient and who markets it?

A “SANSAC” label is insufficient to determine the active pharmaceutical ingredient (API), strength, dosage form, regulatory pathway, or commercial seller in major reference systems (FDA, Orange Book, company filings, or syndicated sales databases). Without an API match, any market dynamics or financial trajectory would be speculative.

How to map “SANSAC” to FDA/Orange Book entries

For a litigation and revenue-timing view, SANSAC must be mapped to:

  • FDA NDA/BLA number(s)
  • Orange Book listing(s) by dosage form and strength
  • market exclusivity type (3-year NCE/505(b)(2), 7-year orphan, pediatric exclusivity, etc.)
  • patent families covering drug substance, drug product, and methods of use

No verified mapping is available to support a correct build.

What patents protect SANSAC and what is the Orange Book status of SANSAC?

Patent and Orange Book status require an FDA NDA/BLA-to-brand mapping. Without an API-to-filing linkage for SANSAC, the patent estate cannot be identified and counted.

How many patents cover the SANSAC product?

Not producible without the Orange Book record. A patent count, expiration map, and paragraph IV challenge assessment depend on:

  • Orange Book patent numbers
  • expiration dates
  • type codes (composition, formulation, use, device, etc.)
  • listed 30-month stay triggers where applicable

When does SANSAC lose exclusivity and when could generics enter?

Exclusivity timing depends on:

  • marketing start date
  • exclusivity expiration date(s)
  • patent expiration dates (and whether listed patents are effectively blocking)
  • whether there are ANDA Paragraph IV challenges or settlement agreements

No verified exclusivity or patent basis can be produced without correct regulatory identification of SANSAC.

What Paragraph IV challenges target SANSAC and which companies are challenging?

Paragraph IV challenge landscape is sourced from:

  • FDA ANDA submissions and dispute dockets
  • court filings and settlements
  • timelines tied to Orange Book patents

No factual challenge list can be built without a specific Orange Book entry.

How does SANSAC pricing evolve: wholesale acquisition cost, rebates, and payer mix?

Price trajectory analysis requires:

  • WAC/NADAC/wholesaler channel data by NDC
  • payer rebate patterns and formulary placement
  • regional or specialty vs primary care segmentation

Without NDC-level identification for SANSAC’s strength and dosage form, pricing and rebate dynamics cannot be quantified.

What is the competitive landscape for SANSAC: branded alternatives, generics, and treatment guidelines?

A credible competitive map requires:

  • the therapeutic indication(s)
  • the API equivalence class
  • competing branded and generic formulations
  • formulary tiers and guideline positioning

“SANSAC” alone does not provide enough regulatory specificity to build the competitive graph.

What financial trajectory does SANSAC show: revenues, margins, and volume trends?

A financial trajectory requires a sales dataset tied to the correct branded product unit (brand API, strength, NDC). Public filings or syndicated IMS/iqvia data are not reliably attributable to “SANSAC” without verifying the product identifier.

How do litigation outcomes affect SANSAC generic or biosimilar risk?

This section cannot be constructed without:

  • the specific patent list
  • litigation docket(s)
  • court outcomes, settlements, and launch-readiness timelines

What formulations of SANSAC are protected by patents and are there abuse-deterrent or delivery system constraints?

Formulation and delivery-system patent analysis depends on Orange Book product patent listings and specification-level claims (e.g., solid-state forms, coatings, particle size, release profiles). Without the correct product entry, no formulation protection can be stated.

Does SANSAC have settlements that delay generic entry or license deals?

Settlement and licensing timelines require:

  • known ANDA applicants and patent dispute docket numbers
  • settlement agreement dates and the effective “launch date” carve-outs
  • any license terms disclosed in court or company releases

No product-to-regulatory mapping is available to produce these facts.

Key Takeaways

  • “SANSAC” cannot be mapped to a unique FDA/Orange Book product identifier from the information provided, so market, exclusivity, patent, litigation, pricing, and revenue trajectory analysis cannot be generated without risking incorrect attribution.
  • A defensible financial and exclusivity timeline requires a verified API and NDA/BLA mapping for SANSAC’s specific strength and dosage form.

FAQs

  1. What does SANSAC stand for in drug registries (NDC/NDA mapping)?
  2. Is SANSAC listed in the FDA Orange Book, and what are its listed patents?
  3. Have any ANDAs filed Paragraph IV certifications against the SANSAC Orange Book listings?
  4. What are the NDC-specific price and rebate patterns for SANSAC across major payers?
  5. What court settlements or consent judgments affect generic entry timing for SANSAC?

References

  1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
  2. U.S. FDA. Drug Application Notifications and ANDA Paragraph IV dispute information (dispute dockets and related resources).

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