Last Updated: June 9, 2026

TOTACILLIN-N Drug Patent Profile


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When do Totacillin-n patents expire, and when can generic versions of Totacillin-n launch?

Totacillin-n is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in TOTACILLIN-N is ampicillin sodium. There are seventy drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Totacillin-n

A generic version of TOTACILLIN-N was approved as ampicillin sodium by SANDOZ on December 31st, 1969.

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Summary for TOTACILLIN-N

US Patents and Regulatory Information for TOTACILLIN-N

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 062727-002 Dec 19, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 062727-001 Dec 19, 1986 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: June 3, 2026

TOTACILLIN-N market dynamics and financial trajectory

TOTACILLIN-N’s market dynamics and financial trajectory cannot be produced because the drug name provided (“TOTACILLIN-N”) does not map to a verifiable, uniquely identifiable pharmaceutical product (active ingredient, dosage form, sponsor/labeler, FDA/EMA status, or any Orange Book/NDA/BLA listing) in the sources required to compile defensible market sizing, pricing trends, launch timing, exclusivity windows, and financial exposure.

What is TOTACILLIN-N and what market does it target?

No verifiable product identity is available from the drug name as given, so therapeutic class, indication set, target geography, and channel structure (hospital vs retail, specialty vs primary care) cannot be stated with source-backed specificity.

Which active ingredient and dosage forms does TOTACILLIN-N use?

Unidentifiable from the provided name. Without an active ingredient and formulation, coverage by supply constraints, GMP capacity, and differentiation (e.g., ER/IR, depot, IV vs oral) cannot be tied to market outcomes.

Who manufactures or markets TOTACILLIN-N?

No sponsor/labeler identity can be confirmed from the provided name, preventing analysis of sales attribution, distribution arrangements, and competitive positioning.


How big is the TOTACILLIN-N market and what pricing trajectory does it show?

Market size, net sales, ASP/WAC movement, reimbursement dynamics, and tender pricing cannot be quantified without a verifiable labeled product and market definition. The name provided does not support extraction of sales series from company filings, pharmacy claims, or country-specific reimbursement databases.

What reimbursement and tender dynamics affect TOTACILLIN-N revenue?

Cannot be mapped to a specific product. Pricing is typically country-specific and tied to tender cycles, formulary listing status, and reference pricing rules, which require an identifiable INN/brand and jurisdiction.

Are there biosimilar or generic price pressures on TOTACILLIN-N?

No. Without an identifiable active ingredient and regulatory status, the presence of generics/biosimilars, reference products, and substitution rules cannot be assessed.


When does TOTACILLIN-N lose exclusivity, and how does that change revenue?

Exclusivity and patent timelines require an NDA/BLA link (or at least an active ingredient, patent family, and jurisdiction). No such mapping is possible from “TOTACILLIN-N” as provided.

What patents protect TOTACILLIN-N and when do key expirations occur?

Cannot be produced without the patent estate. Patent strength, claim scope, and expiry calendars are not available.

How much “generic ramp” risk exists for TOTACILLIN-N after exclusivity loss?

Cannot be quantified without launch status, Paragraph IV history, and settlement or license terms.


What is the Orange Book status of TOTACILLIN-N?

Cannot be stated. Orange Book status requires an NDA number or an unambiguous brand-to-application match.

Which NDAs list TOTACILLIN-N, and what are the listed patents?

Unidentifiable from the provided name.


What patent litigation affects TOTACILLIN-N and generic entry timing?

No litigation dataset can be constructed because the drug and sponsor cannot be verified.

Have any companies filed Paragraph IV challenges against TOTACILLIN-N?

Cannot be determined.

What settlements or consent decrees govern generic timing for TOTACILLIN-N?

Cannot be determined.


What formulations are protected for TOTACILLIN-N and do they constrain generic design-arounds?

Formulation and device delivery constraints require a defined product and formulation composition. Not available.

Are method-of-use patents part of TOTACILLIN-N exclusivity?

Not available.


How does TOTACILLIN-N compare with competing therapies and what drives share shifts?

Comparison requires an identified therapeutic target, efficacy/safety profile, and labeled dosing schedule. Not available.

Which brands or generics compete with TOTACILLIN-N in hospital formularies?

Not available.

What is the uptake driver: clinical differentiation, tender pricing, or switching incentives?

Not available.


What FDA regulatory pathway and key milestones affect TOTACILLIN-N sales?

Regulatory pathway (505(b)(1), 505(b)(2), or 505(j)), approval date, label expansions, and REMS requirements cannot be tied to the drug name provided.

What is TOTACILLIN-N’s approval history, label scope, and post-marketing changes?

Not available.

Are there manufacturing or supply disruptions affecting TOTACILLIN-N availability?

Not available.


Key financial trajectory indicators for TOTACILLIN-N

A financial trajectory requires at least one of: audited net sales, segment reporting, country-level sales, wholesaler movement, or market-access reimbursement signals, all tied to an identifiable product.

Net sales trend, margins, and cash flow sensitivity

Not available.

Working-capital and inventory dynamics

Not available.

Revenue concentration risks (single indication, single payer, single geography)

Not available.


Key Takeaways

  • “TOTACILLIN-N” cannot be mapped to a uniquely identifiable drug product using the name provided, so market dynamics and financial trajectory cannot be compiled into a defensible, data-backed profile.
  • Patent, exclusivity, Orange Book status, litigation risk, regulatory milestones, and competitive share drivers are not producible without an unambiguous product identity.

FAQs

  1. What active ingredient does TOTACILLIN-N contain and under what brand/label name is it approved?
  2. Is TOTACILLIN-N listed in the US FDA Orange Book, and which patents are attached to it?
  3. Have any generic or biosimilar applicants filed Paragraph IV challenges against TOTACILLIN-N?
  4. What jurisdictions (US/EU/UK/other) have TOTACILLIN-N approved and how does that affect market size?
  5. What competitive products substitute for TOTACILLIN-N and what evidence supports switching?

References

No cited sources available because TOTACILLIN-N could not be uniquely identified from the provided name.

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