POMALYST Drug Patent Profile

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

Pomalyst is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in thirty-three countries.

The generic ingredient in POMALYST is pomalidomide. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pomalidomide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pomalyst

A generic version of POMALYST was approved as pomalidomide by BRECKENRIDGE on October 30^th, 2020.

Summary for POMALYST

International Patents:	53
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	83
Patent Applications:	6,655
Drug Prices:	Drug price information for POMALYST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POMALYST
What excipients (inactive ingredients) are in POMALYST?	POMALYST excipients list
DailyMed Link:	POMALYST at DailyMed

See drug prices for POMALYST

Recent Clinical Trials for POMALYST

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

Sponsor	Phase
Megalabs	Phase 1
University of Chicago	Phase 2
Regeneron Pharmaceuticals	Phase 3

See all POMALYST clinical trials

Pharmacology for POMALYST

Drug Class

Thalidomide Analog

Paragraph IV (Patent) Challenges for POMALYST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
POMALYST	Capsules	pomalidomide	1 mg, 2 mg, 3 mg and 4 mg	204026	6	2017-02-08

US Patents and Regulatory Information for POMALYST

POMALYST is protected by three US patents and three FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No	8,828,427*PED				Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	10,555,939*PED				Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	AB	RX	Yes	No	8,828,427*PED				Y

Expired US Patents for POMALYST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	6,315,720
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	8,626,531
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	8,315,886
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	6,561,976
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	6,755,784
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	6,908,432

EU/EMA Drug Approvals for POMALYST

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Imnovid (previously Pomalidomide Celgene)	pomalidomide	EMEA/H/C/002682Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.	Authorised	no	no	no	2013-08-05

International Patents for POMALYST

See the table below for patents covering POMALYST around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010249615
Brazil	PI1007855
Canada	2752550
Chile	2011001969
China	102333525
China	105640918

Supplementary Protection Certificates for POMALYST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0925294	91359	Luxembourg		91359, EXPIRES: 20220614
0925294	CA 2007 00054	Denmark		PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT
0925294	07C0056	France		PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
0925294	SPC033/2007	Ireland		SPC033/2007: 20080507, EXPIRES: 20220613
0925294	SPC/GB07/047	United Kingdom		PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
0925294	SZ 56/2007	Austria		PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES

Last updated: July 25, 2026

Pomalyst (pomalidomide) market dynamics and financial trajectory: exclusivity, generic risk, and earnings exposure

Pomalyst (pomalidomide) is a late-line immunomodulatory drug (IMiD) used primarily in multiple myeloma. Its market trajectory is shaped by (1) the pace of penetration in earlier relapse lines, (2) competitive pressure from other IMiDs (lenalidomide, thalidomide) and proteasome inhibitors (bortezomib, carfilzomib), (3) payer and formulary dynamics for oral oncology, and (4) generic entry risk as key US exclusivity windows and patent estates wind down.

What market dynamics drive Pomalyst sales in multiple myeloma?

Where Pomalyst fits in the treatment sequence

Pomalyst is used in relapsed and refractory multiple myeloma settings, most notably:

• in patients previously treated with lenalidomide and a proteasome inhibitor (common clinical placement in practice for late relapse)
• and in combinations where regulators and compendia support specific relapse contexts (brand and label positioning differ by regimen and jurisdiction)

Market dynamics typically track four demand levers:

1. patient mix shift toward late relapse versus earlier lines
2. adoption of combination regimens that reduce monotherapy share
3. guideline updates that change line-of-therapy selection
4. payer-driven prior authorization and step edits that favor preferred oral agents

Competitive pressure: how other myeloma drugs affect Pomalyst

Pomalyst competes in a crowded oral and infusion-heavy myeloma landscape:

• IMiDs: lenalidomide (Revlimid), thalidomide (Thalomid)
• proteasome inhibitors: bortezomib (Velcade), carfilzomib (Kyprolis)
• anti-CD38 monoclonals: daratumumab (Darzalex), isatuximab (Sarclisa)
• next-generation agents and combination standards that can displace late IMiD use

The practical sales impact: when combination regimens or newer classes shift clinician preferences earlier, the late-relapse IMiD monotherapy and single-agent mix can compress.

Payer and utilization mechanics for oral oncology

Oral oncology spending is sensitive to:

• formulary tier placement and step therapy
• distribution channel contracting
• patient assistance adoption and net-price erosion
• treatment duration and discontinuation rates driven by response and safety tolerance

Pomalyst’s net sales typically follow volume more than unit price because payer contracts for oral oncology often cap annual spending and drive brand-to-generic substitution once permitted by exclusivity and patent status.

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How do exclusivity and patent expirations affect Pomalyst revenue?

When does Pomalyst lose US exclusivity?

Pomalidomide is an older active ingredient. Revenue durability depends on:

• US regulatory exclusivity (e.g., New Chemical Entity status is not relevant for older IMiDs)
• Orange Book-listed patents covering drug substance, drug product, and specific formulations
• method-of-use and combination patents

A full, correct expiration timeline requires a complete Orange Book and patent-family pull for the specific Pomalyst NDCs and listed claims. If that record is not present, a complete and accurate launch-and-expiration map cannot be produced.

What patents protect Pomalyst formulations and dosing?

Pomalyst is an oral capsule product with multiple strengths. Patent protection in this space commonly spans:

• solid-state and polymorph/formulation patents
• particle size, dissolution rate, and manufacturability claims
• method-of-use for relapsed/refractory myeloma dosing and sequencing

A complete mapping of which claims remain enforceable requires the Orange Book listing and the current active claims status.

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What generic entry risks exist for Pomalyst?

Paragraph IV and FDA pathway: what to watch

Generic substitution typically requires:

• ANDA approval under Abbreviated New Drug Applications
• bioequivalence to the reference listed drug (RLD)
• successful handling of patent litigation triggered by Paragraph IV certifications

The key market risk is timing: once a first ANDA is approved and exclusivity for that ANDA expires, additional generics accelerate volume substitution, driving major net-price pressure.

Generic entry exposure is strongest where

Generic risk tends to be highest where:

• Pomalyst is used as a preferred late-line IMiD and there is no meaningful protocol-based switching barrier
• payer formularies already cover multiple IMiDs
• there is no effective late-line combination patent barrier at the time of filing

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What patent litigation affects Pomalyst?

How patent disputes typically impact sales trajectory

Litigation affects sales in two ways:

1. prevents or delays ANDA approval and market launch
2. drives settlement dates that can “lock” generic availability

For an accurate view of Pomalyst’s litigation-driven revenue exposure, the current docket status and settlement terms must be tied to the specific Orange Book patents and asserted claims. Without an available complete citation set, a complete and accurate legal timeline cannot be produced.

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What is the Orange Book status of Pomalyst?

Orange Book status determines:

• the RLD and NDC-level listing
• which patents are listed for each strength
• patent expiration and “use code” coverage (drug substance, drug product, method of use)

A correct Orange Book table requires the actual listing record, including each patent number, expiration date, and certification mapping. Without that dataset, a complete and accurate status summary cannot be produced.

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How strong is the patent estate for Pomalyst versus generics?

Patent strength is a function of claim type and enforceability

For IMiD brands, enforcement strength often comes from:

• late-stage use or regimen-specific claims that create clinical switching resistance
• manufacturing and formulation patents that block generic design-around
• multiple overlapping patents that create staggered barriers

But without a verified list of remaining patents and the enforceable claim status, strength cannot be quantified.

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How does Pomalyst compare with Revlimid and other myeloma standards on market durability?

Net revenue dynamics by class

In myeloma, market durability usually correlates with:

• whether a drug is “line-of-therapy agnostic” versus restricted to a later niche
• how often it is displaced by newer regimens that improve response
• whether payers establish it as a preferred agent

Pomalyst’s durability historically tends to be driven by its role in late relapse, which can be both resilient (high unmet need) and structurally declining (earlier displacement of IMiDs in modern algorithms).

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What is the financial trajectory for Pomalyst (sales trend drivers and forecasting logic)?

Observed trajectory drivers (what moves the line item)

Pomalyst’s financial trajectory in most reporting histories follows:

• volume trends tied to new patient starts, continuation rates, and line-of-therapy distribution
• net price changes driven by rebates, discounts, and payer contracting
• milestone events (regulatory approvals of additional indications or combinations) that expand use
• competitive launches from other myeloma agents that reduce incremental share

Forecasting framework used by investors

A high-intent forecasting model typically breaks future revenue into:

1. base demand for late relapse population and treatment duration
2. share of voice versus other IMiDs and proteasome inhibitors
3. net price path based on formulary status and generic substitution probabilities
4. exclusivity-and-litigation gating events that shift risk from “low” to “high”

A quantified forecast requires current-year revenue and unit/volume data, plus an exact exclusivity calendar.

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Key market and financial risk map for Pomalyst

Risk driver	Market mechanism	Revenue impact direction	What changes it
Line-of-therapy shift	Earlier adoption of other regimens reduces late relapse starts	Down	Guideline updates; clinical trial results altering sequencing
Net price erosion	Payer leverage and rebate pressure for oral oncology	Down	Contract renegotiations; competing preferred agents
Generic approval timing	ANDA entry causes volume substitution	Down sharply	Patent/litigation outcomes; settlement dates
Safety/tolerability	Discontinuations or dose modifications	Down	Label changes; real-world toxicity data
Combination adoption	Regimen shifts can increase or reduce Pomalyst share	Mixed	New evidence for combos; payer coverage

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Key Takeaways

• Pomalyst’s market dynamics are primarily determined by multiple myeloma treatment sequencing, payer contracting for oral oncology, and competitive displacement in relapse lines.
• The dominant financial “tail risk” is generic entry timing in the US, which is controlled by Orange Book patent listings and Paragraph IV litigation/settlements.
• A full, date-accurate exclusivity and patent expiration map for Pomalyst requires the Orange Book and corresponding patent-family record at the NDC level; without that dataset, no correct expiration calendar can be stated.
• Near- and mid-term revenue trajectories typically turn on (1) share in late relapse, (2) net price pressure, and (3) litigation outcomes that gate ANDA approvals.

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FAQs

1. How does payer step therapy affect Pomalyst net pricing in multiple myeloma?
2. What generics are likely candidates for an ANDA to Pomalyst once exclusivity ends?
3. Do Pomalyst combination regimens change generic substitution risk?
4. How do FDA label updates for pomalidomide influence formulary adoption and switching?
5. What competitive signals from Revlimid and other myeloma agents predict Pomalyst demand shifts?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA. Drugs@FDA: Pomalyst (pomalidomide) product information and labeling. (Accessed via Drugs@FDA).

DrugChatter Q&A for POMALYST

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