REMERON SOLTAB Drug Patent Profile

Which patents cover Remeron Soltab, and when can generic versions of Remeron Soltab launch?

Remeron Soltab is a drug marketed by Organon Usa Organon and is included in one NDA.

The generic ingredient in REMERON SOLTAB is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Remeron Soltab

A generic version of REMERON SOLTAB was approved as mirtazapine by TEVA on January 24^th, 2003.

Summary for REMERON SOLTAB

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for REMERON SOLTAB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	AB	RX	Yes	Yes
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	AB	RX	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	AB	RX	Yes	No

International Patents for REMERON SOLTAB

See the table below for patents covering REMERON SOLTAB around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	145551
Australia	646232
Australia	6601290
Canada	2061917	FORME POSOLOGIQUE EFFERVESCENTE POUR ENFANTS (PEDIATRIC EFFERVESCENT DOSAGE FORM)
Germany	69029273
Denmark	0494972

REMERON SOLTAB (mirtazapine orally disintegrating tablet) investment scenario and patent fundamentals analysis

Last updated: July 25, 2026

Remeron SolTab is the branded mirtazapine orally disintegrating tablet (ODT) marketed by Organon in the US. The US competitive risk is structurally high because the underlying mirtazapine active is off-patent, and the branded product’s remaining value depends on what Orange Book-protected formulation, manufacturing, and/or use patents still cover the specific ODT presentation and strength.

Given the lack of complete, verifiable patent-listing and FDA exclusivity details in the provided prompt, this analysis cannot produce a complete, accurate patent estate or litigation timeline for Remeron SolTab in the US.

What patents protect Remeron SolTab and mirtazapine ODT in the US?
No complete patent-claim coverage for Remeron SolTab can be produced from the information provided.

What patent expiration dates drive generic and ODT competition?
No reliable, product-specific expiration schedule for Remeron SolTab can be produced without the exact Orange Book patent numbers and their listed expiry dates for the ODT strengths.

How to assess the remnant patent estate risk for an ODT format

For branded ODT assets, investors should weight remaining protection in three buckets:

1. Formulation patents (ODT matrix, disintegration agents, taste-masking, particle engineering, coating)
2. Manufacturing process patents (granulation/compression steps that preserve disintegration and stability)
3. Method-of-use patents (less common for mirtazapine in ODT, but can exist)

A complete fundamentals view requires mapping those buckets to the Orange Book listings tied to the specific drug product code for Remeron SolTab and to the Paragraph IV challenge record if any.

When does Remeron SolTab lose exclusivity and Orange Book exclusivity periods?
No accurate exclusivity timeline can be produced without Orange Book exclusivity details (new chemical entity, new clinical investigation, pediatric exclusivity, and any product-specific exclusivity) tied to the ODT product.

How many patents cover Remeron SolTab and which assignees own them?
A quantified count of listed patents, their assignees, and their claim scope cannot be produced without the Orange Book patent list for the Remeron SolTab NDC(s).

What generic entry risks exist for Remeron SolTab (Paragraph IV and 505(j))?
No product-specific generic risk assessment can be produced without:

• the relevant Orange Book listing(s)
• whether any ANDA filers submitted Paragraph IV certifications
• the presence of any final court decisions or settlement-triggered launch design-arounds

What patent litigation affects Remeron SolTab in the US?
No litigation docket or settlement status for Remeron SolTab can be stated from the provided prompt.

How strong is the patent estate for mirtazapine orally disintegrating tablets versus immediate-release (IR)?
A comparative estate strength assessment requires knowing which protection is unique to the ODT format (formulation/manufacturing) versus inherited from earlier IR intellectual property. Without Remeron SolTab’s exact patent list, the comparison cannot be made accurately.

What formulations are protected by Remeron SolTab patents?
No claim-level statement on formulation attributes (e.g., disintegrant system, melt-in-mouth mechanics, coating/taste-masking, particle size, binder selection) can be produced without the patent documents or at least the Orange Book-listed patents tied to those claims.

What method-of-use patents apply to Remeron SolTab?
No method-of-use patent coverage can be confirmed for Remeron SolTab from the provided prompt.

What is the Orange Book status of Remeron Soltab NDCs and dosage strengths?
No Orange Book status table can be created without the NDC-specific Orange Book listing data.

How does Remeron SolTab compare with competing mirtazapine products on IP and market access?
A defensible competitor comparison requires mapping:

• each competing product’s NDC to its Orange Book patents
• whether the competitor is IR tablets, ODT, or alternate dosage forms
• each competitor’s certification type (I-IV) and any relevant litigation outcomes

That mapping cannot be done from the provided prompt.

What FDA regulatory status applies to Remeron SolTab (approval pathway, exclusivity, labeling)?
No FDA pathway or exclusivity status details can be reliably stated without the specific FDA approval record and Orange Book exclusivity entries for the ODT product.

Commercial exposure and investment scenario for Remeron SolTab: revenue drivers and downside factors
A fundamentals-based scenario cannot be completed without at least one of the following, none of which is included in the prompt:

• current branded sales and trajectory
• payer mix and pricing pressure indicators
• remaining exclusivity/patent runway and generic penetration status
• any known formulary decisions tied to ODT availability

Investment framework that depends on patent runway (what to model once listings are known)

When Remeron SolTab’s remaining ODT-specific protection is quantified, investors can model:

• Time-to-first generic ODT risk (triggered by expiration or successful Paragraph IV resolution)
• Launch geometry (NDC coverage by strength and label)
• Price compression curve (typical branded to generic steepening after entry)
• Intermediary substitution (IR-to-ODT substitution and patient adherence effects)
• Supply and exclusivity enforcement (authorized generics, settlements, and design-arounds)

Without the Orange Book listing set, those inputs remain blank.

---

Key Takeaways

• A complete Remeron SolTab investment and patent fundamentals analysis requires the Orange Book listing set for the specific ODT NDCs.
• The provided prompt does not include the necessary patent numbers, listed expiries, exclusivity flags, or litigation outcomes to generate an accurate estate, exclusivity timeline, or generic entry scenario.
• Without those verifiable anchors, any quantified patent runway, expiration schedule, or litigation impact would be non-actionable.

FAQs

1. Is Remeron SolTab still protected by formulation patents in the US?
2. Which Orange Book patents are listed for mirtazapine ODT versus mirtazapine IR?
3. Are there any Paragraph IV ANDA challenges specific to Remeron SolTab ODT strengths?
4. What settlement terms typically determine generic launch timing for branded ODTs like Remeron SolTab?
5. How do labeling and NDC-level coverage affect generic substitution risk for Remeron SolTab?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA Drug Approval Reports and approval records for mirtazapine products. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/