Last Updated: June 17, 2026

RIMIFON Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Rimifon is a drug marketed by Roche and is included in one NDA.

The generic ingredient in RIMIFON is isoniazid. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the isoniazid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rimifon

A generic version of RIMIFON was approved as isoniazid by CMP PHARMA INC on November 10th, 1983.

  Start Trial

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

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

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 2

See all RIMIFON clinical trials

US Patents and Regulatory Information for RIMIFON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche RIMIFON isoniazid INJECTABLE;INJECTION 008420-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roche RIMIFON isoniazid INJECTABLE;INJECTION 008420-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roche RIMIFON isoniazid SYRUP;ORAL 008420-001 Approved Prior to Jan 1, 1982 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 10, 2026

RIMIFON market dynamics and financial trajectory: sales, pricing, and IP-driven generic risk

RIMIFON’s market trajectory is not supportable with verifiable commercial data in the provided context. No reliable product identifiers (active ingredient, dosage forms/strengths), FDA approval record, distributor/pricing benchmark, or country-level sales disclosure are included, so a complete market dynamics and financial trajectory assessment cannot be produced without introducing unsupported assertions.

What is RIMIFON’s active ingredient and regulatory status in the US?

Featured snippet answer: Not determined from the provided inputs.

Which FDA application does RIMIFON reference (NDA, ANDA, BLA)

Not determined from the provided inputs.

What is RIMIFON’s Orange Book listing status

Not determined from the provided inputs.

What is RIMIFON’s labeling (indication, dosage form, route)

Not determined from the provided inputs.


How does RIMIFON price and reimbursement evolve over time?

Featured snippet answer: Not determined from the provided inputs.

What are typical acquisition cost and net price drivers

Not determined from the provided inputs.

How do payer controls shape net sales

Not determined from the provided inputs.

Are there tender or wholesaler mix shifts affecting revenue

Not determined from the provided inputs.


When does RIMIFON face generic or biosimilar competition and what is the Paragraph IV risk profile?

Featured snippet answer: Not determined from the provided inputs.

Does RIMIFON have Orange Book patents that drive Paragraph IV challenges

Not determined from the provided inputs.

Which generic entrants are positioned for launch

Not determined from the provided inputs.

What is the likely erosion pattern (early share loss vs slower glide path)

Not determined from the provided inputs.


What patents protect RIMIFON formulations, methods of use, and manufacturing?

Featured snippet answer: Not determined from the provided inputs.

How many patent families cover RIMIFON and what are their expiration windows

Not determined from the provided inputs.

Which jurisdictions matter for enforcement and launch timing

Not determined from the provided inputs.

How formulation changes affect design-around risk

Not determined from the provided inputs.


What litigation settlements or FDA stays affect RIMIFON revenue under Hatch-Waxman?

Featured snippet answer: Not determined from the provided inputs.

Are there active district court cases involving RIMIFON patents

Not determined from the provided inputs.

Has a 30-month stay been triggered for ANDA applicants

Not determined from the provided inputs.

Do licensing agreements set supply and royalty terms

Not determined from the provided inputs.


How do manufacturing capacity and supply reliability impact RIMIFON financial performance?

Featured snippet answer: Not determined from the provided inputs.

Any reported supply disruptions, recalls, or quality events

Not determined from the provided inputs.

What CDMO or internal sites supply RIMIFON

Not determined from the provided inputs.

How constrained supply changes wholesaler purchasing patterns

Not determined from the provided inputs.


How does RIMIFON compare commercially with competitors in its therapeutic class?

Featured snippet answer: Not determined from the provided inputs.

Which brands or generics compete directly

Not determined from the provided inputs.

How do efficacy/safety and administration convenience translate into share

Not determined from the provided inputs.

What role does copay assistance or patient support play

Not determined from the provided inputs.


What is RIMIFON’s financial trajectory by quarter and year (revenue, gross margin, and guidance)?

Featured snippet answer: Not determined from the provided inputs.

Reported sales trend and inflection points

Not determined from the provided inputs.

Gross-to-net dynamics

Not determined from the provided inputs.

Management guidance and revisions

Not determined from the provided inputs.

Segment exposure (if disclosed)

Not determined from the provided inputs.


What investor-relevant events explain RIMIFON performance (launch timing, label expansion, payer changes)?

Featured snippet answer: Not determined from the provided inputs.

New indications or label updates

Not determined from the provided inputs.

Formulary placements or exclusions

Not determined from the provided inputs.

Regulatory actions that change commercial outcomes

Not determined from the provided inputs.


Key Takeaways

  • RIMIFON market dynamics and financial trajectory cannot be quantified or anchored to verifiable regulatory, pricing, or sales records from the provided information.
  • A defensible analysis requires product identity mapping to FDA/Orange Book, competitive set identification, and audited financial disclosures.

FAQs

  1. What active ingredient does RIMIFON contain and what therapeutic class does it belong to?
    Not determined from the provided inputs.

  2. Is RIMIFON listed on the FDA Orange Book, and which patents are associated with its NDA?
    Not determined from the provided inputs.

  3. Are there any Paragraph IV ANDA filings against RIMIFON and what is the litigation timeline?
    Not determined from the provided inputs.

  4. How has RIMIFON’s net pricing changed due to payer contracting or formulary shifts?
    Not determined from the provided inputs.

  5. Which competitors have the highest revenue overlap with RIMIFON and what market share trend should be expected?
    Not determined from the provided inputs.


References (APA)

No sources cited because no product-identifying facts, regulatory records, or financial disclosures were provided in the prompt.

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.