When do the patents on TOFRANIL-PM expire, and when will TOFRANIL-PM go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	TOFRANIL-PM	imipramine pamoate	CAPSULE;ORAL	017090-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Specgx Llc	TOFRANIL-PM	imipramine pamoate	CAPSULE;ORAL	017090-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Specgx Llc	TOFRANIL-PM	imipramine pamoate	CAPSULE;ORAL	017090-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Specgx Llc	TOFRANIL-PM	imipramine pamoate	CAPSULE;ORAL	017090-003	Approved Prior to Jan 1, 1982		DISCN	Yes	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 6, 2026

Tofranil-PM (Desipramine) Investment Scenario and Patent/Regulatory Fundamentals Analysis

Executive summary: Tofranil-PM is a branded, once-daily, extended-release formulation of desipramine hydrochloride (tricyclic antidepressant, TCA). Investment exposure is driven by (1) whether branded exclusivity has ended for the specific modified-release formulation, (2) Orange Book and patent landscape around the extended-release matrix/dosage form, and (3) actual market access headwinds for legacy TCAs (generic pressure, payer migration, and safety/tolerability constraints inherent to TCAs). For investment underwriting, the central diligence track is the patent estate tied to the specific controlled/extended-release formulation and the regulatory exclusivity status for the listed NDA product; most of the market value typically consolidates quickly after generic entry.

What is Tofranil-PM and what drug class fundamentals drive demand?

Featured snippet: Tofranil-PM is an extended-release version of desipramine hydrochloride, a tricyclic antidepressant used for depression and other indications depending on label. Demand is constrained by class adoption of newer antidepressants and safety monitoring requirements typical of TCAs.

Key commercial demand drivers for TCAs

Efficacy vs newer antidepressants: TCAs can be effective but are less favored where SSRIs/SNRIs and other classes dominate prescribing due to safety and tolerability.
Tolerability and monitoring: TCAs have anticholinergic effects, weight gain risk, sedation, and cardiac conduction concerns in susceptible patients. This drives prescriber caution and payer utilization management.
Formulation preference: Extended-release can improve adherence and reduce peak-trough side effects, but does not typically protect against generic substitution if formulation patents do not remain enforceable.
Geography and channel: Legacy branded products often show declining share as generics become entrenched unless payer contracts continue to favor branded supply.

Formulation relevance for investors

Extended-release TCAs are a high-risk segment for brand durability because:

Generic manufacturers can often develop alternative extended-release technologies unless specific formulation patents remain valid and enforceable.
Even when the API is long off-patent, the brand value depends on whether the dosage-form IP blocks generic “same-release” competition.

What is the Orange Book status of Tofranil-PM and what patents control the label product?

Featured snippet: The practical question for investors is not whether desipramine is patent protected, but whether the Orange Book lists remaining, product-specific patents for the extended-release Tofranil-PM NDA.

How investors should read the Orange Book for Tofranil-PM risk

The Orange Book list typically includes:

Drug substance (API) patents for desipramine hydrochloride
Drug product (formulation, release mechanism, dosage form) patents for extended-release characteristics
Method-of-use patents if applicable (less common for legacy TCAs but possible for specific labeled uses)
Orphan exclusivity or other exclusivity only if the NDA had such status (rare for TCAs)

Investment implication: If the remaining listings are concentrated in drug product formulation patents, generic entry timing hinges on Paragraph IV (or non-infringing) routes targeting those patents.

Patent estate mapping framework (what matters)

For diligence, the underwriting model should separate:

Earliest expiration of listed patents relevant to generic “tofranil-PM-like” extended-release products
Likelihood of validity/enforceability challenges based on claim scope and remaining term
Design-around plausibility for extended-release technology

If investors underwrite assuming API freedom but miss formulation patent risk, valuation can be overstated.

When does Tofranil-PM lose exclusivity, and what timing matters for generic entry?

Featured snippet: Tofranil-PM loses market exclusivity for its specific branded formulation when (a) listed patents expire, and (b) any regulatory exclusivity tied to the NDA or approved use is exhausted.

The exclusivity timing stack investors use

Patent expiration (listed Orange Book patents)
PTE/PTE-like adjustments (if any were granted to the NDA; rare for legacy products but must be verified in listing history)
Regulatory exclusivity (5-year new chemical entity, 7-year orphan, 3-year new clinical studies, etc.) tied to original approval or supplemental approvals
Generic launch clock after patent expiry (or after a favorable legal outcome after Paragraph IV)

Generic launch scenario logic

A typical risk-weighted scenario for legacy extended-release TCAs:

Best case for brand: formulation patents still valid later into the forecast window; generics delay entry or launch “at risk” with settlements.
Base case: no enforceable formulation barrier; generics launch shortly after expiration.
Worst case: formulation patents are narrow or weak and fall in early litigation; brand loses share faster than modeled.

How many patents cover Tofranil-PM extended-release formulations, and how strong is that estate?

Featured snippet: For Tofranil-PM, investment strength is determined by whether Orange Book “drug product” patents cover the extended-release mechanism in a way that is hard to design around.

What “strong estate” means for investors

An enforceable extended-release formulation estate typically has:

Claims that are difficult to replicate with different matrices/coatings
Claims tied to measurable release profiles that correlate with clinical use
Dependable chain-of-title and manageable inventorship challenges
Real remaining term aligned with expected generic entry

What “weak estate” tends to look like

Claims that are overly functional (generic can argue non-infringement)
Multiple generations of formulation patents with staggered expiration but limited independent claim breadth
Prior art pressure likely weakening validity

Investment impact: Weak formulation IP shifts the valuation curve toward “generic normalization” and increases risk of rapid price erosion.

What patent litigation affects Tofranil-PM, including Paragraph IV cases and settlements?

Featured snippet: For Tofranil-PM, litigation matters only where there are active Paragraph IV filings targeting Orange Book formulation patents for the specific NDA product.

How to interpret litigation outcomes for valuation

Filed Para IV + loss of injunctive relief usually accelerates generic timelines
Settlement agreements can “lock in” launch dates through reverse payment or covenant not to sue structures
Adverse district court or CAFC outcomes can convert “at risk” launch into sustained generic competition

Underwriting lens for legacy TCAs

Because desipramine is old, litigation often becomes a narrow contest over:

Extended-release formulation patents
Specific pharmacokinetic release characteristics tied to the approved dosage form

If there is no credible active Para IV or enforcement, investors should model generic erosion as the base case.

What generic entry risks exist for Tofranil-PM, and what barriers can delay substitution?

Featured snippet: The generic substitution risk for Tofranil-PM is mostly formulation- and enforcement-driven; API substitution is not a barrier. Barriers include enforceable extended-release patents, legal outcomes, and payer contract dynamics.

Practical generic entry risk factors

Formulation design-around feasibility: If generics can match dissolution/release specs via different excipients or polymers, patent value drops.
ANDA development complexity: Extended-release pharmacotechnical work increases time and cost but is usually manageable.
Bioequivalence strategy: For modified-release products, BE can still be routine with proper product development, reducing regulatory barriers.
Payer and PBM behavior: Even after launch, substitution can be slower if brand contracts or formularies retain coverage.

How does Tofranil-PM compare with other desipramine products and extended-release TCAs?

Featured snippet: Tofranil-PM competes with other desipramine presentations and broader antidepressant classes; its competitive moat, if any, is the specific extended-release performance and resulting tolerability/adherence profile.

Investor comparison dimensions

Dosage form: extended-release vs immediate-release desipramine
Dosing convenience: once-daily vs multiple daily dosing
Payer access: formulary positioning often favors generics and preferred antidepressant classes
Safety monitoring burden: class and patient-level factors drive utilization more than slight pharmacokinetic differences

What typically happens in markets for legacy TCAs

Generics capture share quickly once product-specific barriers end.
Brand survival depends on contract geography, stable patient cohorts, and limited prescribing shift away from desipramine.

What manufacturing and IP barriers apply to desipramine extended-release products?

Featured snippet: For Tofranil-PM-like extended-release products, manufacturing risk is tied to achieving the approved release profile while avoiding infringing formulation claims.

Manufacturing execution factors investors underwrite

Release control consistency: batch-to-batch dissolution and release kinetics
Excipient supply stability: extended-release systems can be sensitive to polymer grade and processing parameters
Scale-up risk: extended-release technologies can face yield variability and sticking
Regulatory comparability: generic sponsors must demonstrate BE and robust quality controls

IP barriers: If formulation patents are enforceable, manufacturing can create added “freedom-to-operate” cost even after BE success.

What FDA regulatory pathway issues matter for Tofranil-PM generics and follow-ons?

Featured snippet: For generics, the main pathway is ANDA with bioequivalence and Paragraph IV against Orange Book patents if applicable.

Regulatory issues that impact launch timing

ANDA approval timing: typically faster for already-developed dosage forms, slower when the release mechanism requires new development
Label and substitution: generic labeling must align; interchangeability practices can still be delayed by payer policies
Data completeness: modified-release bioequivalence can require careful study design to satisfy FDA expectations

Revenue exposure: how much value is typically left for a branded extended-release TCA like Tofranil-PM?

Featured snippet: Branded revenue exposure is usually concentrated in short windows after any exclusivity pivot; otherwise value is heavily diluted by generic share and price erosion.

Valuation levers for investors

Remaining exclusivity horizon: months-to-years remaining affects discount rate sensitivity
Generic count post-launch: market share pressure accelerates with multiple ANDA entries
Payer coverage: PBM tiers and contract terms determine realized net price
Switching costs: minimal for small-molecule generics, more relevant where prescriber patterns and patient stability persist

Key Takeaways

Tofranil-PM is a desipramine extended-release product, where the investment question is almost entirely about product-specific formulation IP and Orange Book exclusivity status, not API validity.
Generic entry risk is high once listed patents expire or are weakened by litigation or settlement.
Investment underwriting should hinge on (1) Orange Book drug product patents for the extended-release dosage form, (2) whether Para IV challenges exist and their procedural posture, and (3) expected generic launch timing versus payer-driven substitution speed.
For legacy TCAs, commercial durability usually declines quickly after exclusivity barriers fall, with value persisting mainly through remaining IP and contracting.

FAQs

What patents typically protect extended-release desipramine products besides the active ingredient?
How do Paragraph IV filings change generic launch timing for legacy branded extended-release antidepressants?
What evidence in Orange Book listings distinguishes drug product formulation patents from method-of-use patents?
What factors most influence bioequivalence success for modified-release generics of small-molecule TCAs?
How do payer formularies and PBM tiers affect realized net pricing after generic entry for Tofranil-PM-like drugs?

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Drug/Listing information for tofranil-PM).
FDA. ANDA Bioequivalence Guidance and related modified-release bioequivalence guidance documents.
FDA. Patent and Exclusivity Information for NDA/ANDA products.
FDA. Approved Drug Products databases for Tofranil-PM product status and regulatory history.

TOFRANIL-PM Drug Patent Profile

When do Tofranil-pm patents expire, and when can generic versions of Tofranil-pm launch?

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tofranil-pm

AI Deep Research

Questions you can ask:

Summary for TOFRANIL-PM

US Patents and Regulatory Information for TOFRANIL-PM