pemetrexed - Profile

What are the generic drug sources for pemetrexed and what is the scope of patent protection?

Pemetrexed is the generic ingredient in six branded drugs marketed by Actavis, Eagle Pharms, Avyxa Holdings, Lilly, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-nine NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pemetrexed has seven patent family members in five countries.

There are three tentative approvals for this compound.

Summary for pemetrexed

International Patents:	7
US Patents:	4
Tradenames:	6
Applicants:	24
NDAs:	29
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pemetrexed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pemetrexed

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Generic filers with tentative approvals for PEMETREXED

Applicant	Application No.	Strength	Dosage Form
		500MG	INJECTABLE;INJECTION
		1G	INJECTABLE;INJECTION
		500MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for pemetrexed

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419-003	Aug 21, 2020		RX	Yes	Yes
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419-001	Aug 21, 2020		RX	Yes	Yes
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419-002	Aug 21, 2020		RX	Yes	Yes
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes			Y

Expired US Patents for pemetrexed

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020

EU/EMA Drug Approvals for pemetrexed

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Alimta	pemetrexed	EMEA/H/C/000564Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.Non-small-cell lung cancerAlimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.	Authorised	no	no	no	2004-09-20
KRKA d.d.	Pemetrexed Krka	pemetrexed	EMEA/H/C/003958Malignant pleural mesotheliomaPemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2018-05-22
Menarini International Operations Luxembourg S.A.	Ciambra	pemetrexed	EMEA/H/C/003788Malignant pleural mesothelioma, , Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer, , Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,	Authorised	yes	no	no	2015-12-02
Fresenius Kabi Deutschland GmbH	Pemetrexed Fresenius Kabi	pemetrexed	EMEA/H/C/003895Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2016-07-22
medac Gesellschaft für klinische Spezialpräparate mbH	Pemetrexed medac	pemetrexed	EMEA/H/C/003905Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer Pemetrexed medac in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Pemetrexed medac is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,	Authorised	yes	no	no	2015-11-26

International Patents for pemetrexed

Country	Patent Number	Title	Estimated Expiration
Canada	2962383	FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
Canada	3015436	FORMES CRISTALLINES DU DIACIDE DE PEMETREXED ET LEURS PROCEDES DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
European Patent Office	3212193	FORMES CRISTALLINES DU DIACIDE DE PÉMÉTREXED ET LEURS PROCÉDÉS DE PRODUCTION (CRYSTALLINE FORMS OF PEMETREXED DIACID AND MANUFACTURING PROCESSES THEREFOR)
Israel	251405	צורות גבישיות של פמטרקסד די-חומצה ושיטות להכנתן (Crystalline forms of pemetrexed diacid and manufacturing processes therefor)
Taiwan	201619161	Crystalline forms of pemetrexed diacid and manufacture processes therefor

Supplementary Protection Certificates for pemetrexed

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	7/2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920

Pemetrexed Investment Scenario and Fundamentals: Patent/Generic Risk, FDA Status, Market Structure, and Valuation Watchpoints

Last updated: July 5, 2026

Pemetrexed (brand: Alimta; active ingredient: pemetrexed disodium, antifolate chemotherapy) is a mature oncology franchise with heavy generic penetration risk. Core investment drivers are (1) how long branded demand persists versus generics by strength and formulation, (2) remaining exclusivity or patent headroom for specific pemetrexed presentations, (3) biosurrogates not applicable because pemetrexed is small molecule, (4) payer and hospital purchasing dynamics, and (5) the likelihood of additional price compression from low-cost entrants.

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What is the market and revenue exposure profile for pemetrexed (Alimta) by indication and dose strength?

Quick answer: Pemetrexed is broadly used across non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma (MPM) regimens, typically in combination or maintenance settings. Revenue exposure concentrates in the US and major ex-US oncology markets, with unit demand supported by guideline-based use and institutional purchasing.

Indication mix that drives procurement

Key clinical use patterns where pemetrexed is embedded in standard-of-care:

• MPM: pemetrexed plus cisplatin and later-line use patterns depending on local label interpretation.
• NSCLC non-squamous: pemetrexed plus platinum regimens and maintenance in eligible patients.
• NSCLC squamous: generally uses alternative regimens, limiting addressable penetration versus non-squamous.

Dose strength and administration economics

Investment-relevant procurement variables:

• Pemetrexed is a sterile injectable requiring reconstitution and preparation steps.
• Facilities standardize workflows by vial strength and packaging format; this affects conversion from branded to generic, especially when supply continuity is prioritized.

Expected revenue pressure mechanism

• Once generics gain share, hospital procurement shifts strongly to lowest landed price plus supply reliability.
• Branded unit economics typically compress faster than volume can offset due to chemotherapy budget controls and DRG bundling effects in some settings.

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What is the FDA approval and Orange Book status of Alimta (pemetrexed), and how does that map to generics?

Quick answer: Pemetrexed products have FDA-approved ANDA pathways once listed patents expire or are invalidated. Generic entry timing and launch feasibility are determined by which patents are listed for the specific NDA and which expire last (or are successfully cleared via Paragraph IV litigation).

Where the patent “last mile” sits

For small-molecule injectables, Orange Book risk is usually dominated by:

• Drug substance patents
• Drug product/formulation patents
• Method-of-use patents (less common for chemotherapy standards after broad exclusivity periods, but still possible)
• Manufacturing process patents (can impede “authorized” but are often easier to bypass with different processes unless claims cover product-by-process features that are hard to design around)

What investors should track in Orange Book updates

High-signal items:

• New patent listings or re-listings tied to improvements in manufacturing, stability, or formulation.
• Patent term adjustments (PTA) that shift expiration.
• Transfers of patent ownership to different entities that sometimes correlate with litigation posture.

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What patents protect pemetrexed and Alimta, and when do they expire?

Quick answer: Pemetrexed is an older oncology agent with patent estates that largely sit in the expiration phase in major markets. The practical investment question is less “whether patents exist” and more “whether any listed patents remain enforceable for the specific US presentations that could block generic entry.”

Because the requested patent-expiration and listing-specific mapping requires the current Orange Book and patent estate identifiers for the exact NDA/BLA and presentations, and because those data are not provided in the prompt, this analysis cannot be completed with accurate, actionable expiration dates, claim scopes, and jurisdictional coverage.

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When does pemetrexed lose exclusivity and how soon could generics fully substitute in the US?

Quick answer: Exclusivity is typically already largely consumed for pemetrexed in the US; the remaining question is whether any late-expiring product- or method-linked patents delayed full generic replacement for specific presentations.

This section requires current, presentation-level FDA and patent listings to determine:

• the latest patent expiration for each strength,
• any pediatric exclusivity extensions,
• the presence and outcomes of any Paragraph IV challenges.

No source data for those listings are included in the prompt, so a complete and accurate exclusivity timeline cannot be produced.

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What generic entry risks exist for pemetrexed (Paragraph IV), and what litigation outcomes matter?

Quick answer: For mature chemotherapy drugs, Paragraph IV challenges generally drive entry by forcing clearance of listed patents. The investment risk is tied to whether (a) litigation settlements delay launch dates, (b) courts invalidate key claims, or (c) the claimant enters “at risk” and gains share ahead of final resolution.

A correct assessment requires:

• case dockets,
• asserted patents and claim constructions,
• settlement agreements and their effective launch dates,
• FDA approval dates for ANDAs and labeling carve-outs by strength and NDC.

The prompt does not provide litigation or FDA-ANDA history, so this cannot be completed accurately.

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How strong is the patent estate for pemetrexed and what is the probability-weighted enforceability horizon?

Quick answer: The enforceability horizon for older small-molecule injectables is usually short once the last listed patents expire and any litigation is resolved. For pemetrexed, enforceability strength is judged by whether any formulation or manufacturing-process patents remain listed and unexpired, and whether any method-of-use patents still materially block generic labeling.

A probability-weighted assessment requires:

• full list of listed patents with expiration dates,
• whether any are subject to ongoing litigation or injunctions,
• status of ANDA approvals linked to each patent.

No patent-list dataset is provided, preventing a complete, data-backed probability-weighted horizon.

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What formulations are protected for pemetrexed (drug product patents) and do they affect generic substitutability?

Quick answer: For injectables, formulation patents can be decisive if they protect:

• specific excipient systems,
• stability improvements,
• reconstitution/handling parameters affecting shelf-life,
• container-closure systems.

However, generic substitutability usually improves once ANDA applicants can match reference-listed product parameters.

This analysis requires the formulation-relevant patent identifiers and claim coverage, which are not provided.

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What manufacturing and process patents could block generics for pemetrexed, and how do design-arounds typically work?

Quick answer: Manufacturing-process patents can block generic supply if claims are tightly product-by-process or if equivalence standards make workarounds difficult. For chemotherapy injectables, process claims often become less limiting if generics can demonstrate equivalent stability and specifications without using protected processing steps.

A correct investment view requires:

• whether any process patents are still listed and unexpired,
• whether there are estoppel provisions from prior litigation,
• whether ANDAs reference the same manufacturing route.

No such information is supplied.

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How does pemetrexed compare with other platinum-based and antifolate lung cancer regimens in terms of competitive positioning?

Quick answer: Pemetrexed competes with other chemotherapy backbones rather than targeted therapies alone. Competitive positioning depends on:

• tolerability profiles that allow broad use,
• guideline inclusion in non-squamous NSCLC and MPM,
• the extent to which payers prefer lower-cost regimens.

Competitive set for fundamentals

Competitive pressure often comes from:

• other chemotherapy combinations (platinum plus alternatives),
• immunotherapy plus chemotherapy standards that can reduce pure chemo-only share,
• generic chemotherapy price compression cycles.

This section can be completed at a qualitative level only; for a quantifiable investment scenario, it requires market share and gross-to-net estimates, which are not provided.

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Is biosimilar risk relevant for pemetrexed?

Quick answer: No. Pemetrexed is a small-molecule drug, so biosimilar frameworks and biosimilar exclusivity do not apply.

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What FDA regulatory pathway and labeling details shape pemetrexed’s competitive landscape?

Quick answer: Generic competition occurs via ANDA referencing the listed drug, with labeling tied to approved indications and any carve-outs permitted by patent litigation outcomes.

Key labeling elements that drive substitution and payer coverage:

• indication wording,
• dosing schedule,
• patient eligibility and administration requirements,
• supportive care instructions (e.g., folate and vitamin supplementation protocols).

A fully actionable regulatory analysis requires the specific FDA label history, which is not provided.

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What settlement agreements or authorized generics could extend branded demand for pemetrexed?

Quick answer: The typical mechanism in mature small molecules is:

• settlement-based launch date commitments,
• possible “workaround” labeling that delays substitution for some indications or strengths,
• authorized generics that retain some pricing discipline while suppressing branded competition.

This requires settlement documentation and ANDA approval timelines.

No litigation/settlement data are included in the prompt, so this cannot be completed.

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What commercial drivers should investors monitor for pemetrexed (pricing, supply, contracting, and tender dynamics)?

Quick answer: The most decision-useful drivers are:

• net price and gross-to-net trends as generics expand,
• tender outcomes and group purchasing organization (GPO) contract awards,
• supply continuity and lead times that influence hospital switching,
• inventory cycles around key competitive milestones.

Pricing compression signals to track

• Use of wholesalers and specialty distributors’ pricing indices where available.
• Contract pricing shifts to generics by NDC strength.
• Volume mix moving from branded to lowest-priced authorized or unbranded generics.

Supply and continuity signals

• manufacturing outages and remediation events can temporarily delay tender switching.
• multiple generic suppliers can reduce single-source risk but increase price competition.

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Investment scenario framework: three-base-case outlook for pemetrexed over the next 24–48 months

Quick answer: With no presentation-specific patent and litigation timeline supplied, the only defensible structure is a scenario table grounded in generic substitution dynamics rather than exact “launch after X date” claims.

Scenario	What happens commercially	Patent/IP assumption	Expected impact on branded economics	What to watch
Base	Continued generic share growth by strength	No remaining late-expiring blockers that meaningfully delay substitution	Ongoing net price compression and reduced unit economics	Tender awards to generics, net price trajectory
Upside	Slower-than-expected switching due to supply/contract inertia or partial label/presentation constraints	Any remaining barriers are modest but operationally meaningful	Better-than-feared revenue retention in targeted channels	Contract renewal terms, NDC-level mix
Downside	Accelerated tender switching and multiple low-cost entrants	No late barriers; litigation delays absent	Rapid margin contraction	Inventory build-ups, supplier undercutting

This framework is actionable for monitoring but cannot tie to dated milestones without Orange Book and litigation inputs.

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Key Takeaways

• Pemetrexed fundamentals are dominated by small-molecule generic substitution dynamics and chemotherapy contracting behavior, not biosimilar risk.
• The investment question is presentation-specific: whether any remaining enforceable Orange Book-listed patents materially delay substitution for specific strengths/NDCs.
• Without current Orange Book listings, ANDA launch status, and litigation outcomes, a date-specific patent and generic-entry forecast cannot be produced accurately.
• Near-term monitoring should focus on net price/gross-to-net, GPO tender wins, NDC-level volume mix, and supply continuity.

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FAQs

1. How does pemetrexed net price typically change after generic entry by NDC strength?
2. Do method-of-use patents for pemetrexed meaningfully delay generic substitution, or is drug product patent coverage more important?
3. What tender contracting levers most affect hospital switching from Alimta to generics (lead time, rebate terms, or supply assurance)?
4. How do folate supplementation label instructions affect clinical adoption and reimbursement continuity for pemetrexed generics?
5. What supply-chain risks (single-site manufacturing, recalls, raw-material constraints) can temporarily slow generic share gains for sterile oncology injectables like pemetrexed?

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References

(No sources were provided in the prompt for FDA Orange Book status, patent listings, litigation dockets, or ANDA approvals; therefore no citable materials can be listed.)