PEMFEXY Drug Patent Profile

When do Pemfexy patents expire, and when can generic versions of Pemfexy launch?

Pemfexy is a drug marketed by Eagle Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in five countries.

The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the pemetrexed profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pemfexy

A generic version of PEMFEXY was approved as pemetrexed by ACTAVIS on August 21^st, 2020.

Summary for PEMFEXY

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	24
Patent Applications:	3,803
Drug Prices:	Drug price information for PEMFEXY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMFEXY
What excipients (inactive ingredients) are in PEMFEXY?	PEMFEXY excipients list
DailyMed Link:	PEMFEXY at DailyMed

See drug prices for PEMFEXY

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

Constraining patent/regulatory exclusivity:

9,604,990

NDA:

209472

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.

Recent Clinical Trials for PEMFEXY

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

Sponsor	Phase
SCRI Development Innovations, LLC	Phase 2
Pfizer	Phase 2
NRG Oncology	Phase 3

See all PEMFEXY clinical trials

Pharmacology for PEMFEXY

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

US Patents and Regulatory Information for PEMFEXY

PEMFEXY is protected by five US patents.

This potential generic entry date is based on patent 9,604,990.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	12,115,164
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	11,793,813		Y
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	9,604,990			Y

Expired US Patents for PEMFEXY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020	7,772,209

EU/EMA Drug Approvals for PEMFEXY

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

International Patents for PEMFEXY

When does loss-of-exclusivity occur for PEMFEXY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

European Patent Office

Israel

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PEMFEXY around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	359823
Australia	6968801
Cyprus	1107649
Germany	60127970

Supplementary Protection Certificates for PEMFEXY

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

PEMFEXY market dynamics and financial trajectory: sales, pricing pressure, competitive threats, and exclusivity-driven inflection points

Last updated: July 2, 2026

PEMFEXY sales and profitability are driven by how quickly competitors erode market access after launch, plus the timing of patent and regulatory exclusivity expirations that determine generic and biosimilar entry risk. The financial trajectory depends on payer coverage decisions, site-of-care shifts, and the extent of patent-protected line extensions (formulations, dosing, and method-of-use).

What is PEMFEXY and what market does it serve?

PEMFEXY is a prescription oncology drug. Market dynamics typically map to: patient demand growth, sequencing with standard-of-care regimens, payer constraints driven by budget impact, and clinician adoption influenced by efficacy readouts in tumor subtypes. Revenue trajectories for oncology brands usually show an early uptake curve, then flatten as formulary placements tighten and competitors take share via pricing, contracting, and clinical differentiation.

What is PEMFEXY’s commercial positioning in oncology?

Featured drivers of adoption and sustained use:

• Indication breadth across lines of therapy (frontline vs later-line)
• Compatibility with common partner regimens (combination uptake)
• Administration convenience (site of care, infusion time, supportive care requirements)
• Clinical guideline inclusion and payer prior authorization barriers

How do payer dynamics typically affect PEMFEXY net sales?

Net sales typically deviate from gross invoice due to:

• Rebates tied to utilization and channel mix
• Narrow formulary status and step edits
• Contracting dynamics with large pharmacy benefit managers and GPO-affiliated oncology practices
• Patient assistance programs that shift copay cards into insured accounts

When does PEMFEXY face exclusivity pressure and how does that affect sales?

Brand sales typically peak when exclusivity is intact and demand is stable, then compress as generic competition becomes feasible. The key question for financial trajectory is whether PEMFEXY faces:

• Loss of regulatory exclusivity (application-specific)
• Patent expiration for the active ingredient or key formulations
• Paragraph IV triggers (for generics) that create settlement-driven timelines
• For biologics: biosimilar interchangeability or exclusivity carve-outs (not applicable if PEMFEXY is not biologic)

What are the revenue inflection points tied to exclusivity?

For most oncology launches, the major inflection points are:

• Early adoption phase: uptake into community and academic centers
• Mid-cycle: formulary normalization plus competition from next-generation entrants
• Late-cycle: acceleration in prescribing volume ahead of perceived “last-time-to-treat” windows if guidance and payer policies anticipate substitution or stocking changes
• Post-expiration: price erosion, share loss, and margin compression

How do patent timing mechanics translate into entry risk?

Financial impact depends on whether competitors can launch:

• At the earliest non-patent-protected date
• After a court or PTAB outcome removes injunction risk
• Only after settlement that keeps the brand exclusive through a delayed launch date

What patents protect PEMFEXY and how strong is the patent estate?

The competitive and financial pathway is shaped by the density and enforceability of:

• Composition-of-matter patents on the active ingredient
• Formulation and polymorph patents (if relevant)
• Method-of-use patents tied to biomarker-defined patient populations or dosing schedules
• Manufacturing method patents that block “workarounds” by generic applicants

How many patents typically cover a branded oncology drug like PEMFEXY?

A strong estate usually includes:

• Multiple families for composition
• Additional families for formulations and administration
• Separate claims for dosing schedules and specific therapeutic regimens

Which claim types most affect generic entry risk?

• Composition-of-matter claims determine the earliest carve-out window
• Method-of-use claims can delay approval designations for label scope even when active ingredient patents expire
• Formulation patents can keep a “brand-only” product profile in place if substitution requires a materially different dosage form

What is the Orange Book status of PEMFEXY and what does it imply for generic launch?

Orange Book listings define which patents a generic challenger must address via Paragraph IV. When the Orange Book contains blocking patents that cover the drug product’s approved claims, launch is typically delayed until patent expiry or resolution.

Orange Book dynamics that change financial outcomes

• Patent “expiration clustering” drives the date when multiple generic launches become feasible
• If PEMFEXY has multiple listed patents with staggered expirations, the brand’s revenue usually declines in steps, not a single cliff
• Settlement structures often convert uncertain litigation into predictable launch dates for competitors

How do Paragraph IV challenges against PEMFEXY impact timelines and revenue?

Paragraph IV is the most common mechanism that converts patent expiration risk into litigation risk with potential launch delays through settlement.

What entry scenarios do Paragraph IV filings create?

• “Launch-at-risk” if a court stay is lifted and patents are not found infringed
• Delay-through-settlement where the brand pays for exclusivity around a specific launch date
• Negotiated carve-outs where generics receive narrower label scope, reducing TAM

How do settlement agreements affect net sales?

Net sales often remain comparatively stable until the effective settlement launch date. If multiple Paragraph IV filers line up, pricing pressure can arrive in waves, driving margin compression even before the full generic market share is realized.

Which companies are challenging PEMFEXY and how might that reshape the competitive landscape?

Financial trajectory correlates with the challenger set:

• If a single generic files early, competition may be slower but more concentrated.
• If multiple filers exist, the brand can face faster contracting and rapid price erosion after entry.
• Competitors with established oncology manufacturing capacity and strong payer contracting can enter with lower friction.

How does competitor capability change launch speed?

• Ability to scale manufacturing and maintain quality systems
• Experience with oncology distribution and wholesaler relationships
• Contracting sophistication with group purchasing and hospital formularies

What formulations are protected for PEMFEXY and why does it matter for market access?

For branded oncology products, formulation and device-level differentiation can matter as much as active ingredient coverage.

How do product-form patents delay substitution?

Key barriers include:

• Patents on release kinetics (immediate vs extended release)
• Device patents that affect infusion workflow
• Stability and manufacturing patents that prevent generic product approval on equivalence

How does PEMFEXY compare with competing oncology therapies in pricing and uptake?

Revenue trajectory is determined by:

• Comparative efficacy in head-to-head or network meta-analysis
• Safety and supportive care burden
• Place in treatment guidelines and payer pathway controls
• Net price and contract effectiveness

What typically drives share shift after competitor entry?

• Improved response rates or reduced toxicity in defined biomarker subgroups
• Lower total cost of care through reduced administration or fewer adverse events
• Better payer access through stronger formulary placement and rebate positioning

What generic entry risks exist for PEMFEXY?

Generic entry risks are a function of regulatory readiness and the legal timing created by Orange Book-linked patents.

Entry risk checklist for oncology generics

• Earliest feasible approval date based on patent expiry and regulatory exclusivity
• Whether Paragraph IV litigation has an enforceable stay
• Whether label carve-outs reduce clinical relevance
• Ability to obtain payer contracting at acceptable rebates early enough to sustain volume

What is the FDA regulatory status of PEMFEXY and how does that affect commercialization?

FDA status affects market access through:

• Label scope and approved indication breadth
• Risk evaluation and mitigation requirements that influence prescribing and administration
• Submission type for future line extensions and what that means for patent listing on the Orange Book

What regulatory mechanisms affect switching and access?

• New indication approvals can reset the commercial curve by expanding eligible patient populations
• Updates that widen use can increase utilization before expiry
• REMS or postmarketing study requirements can slow access or change prescriber comfort

What manufacturing and IP barriers could delay PEMFEXY generic substitution?

Even with patent expiry, manufacturing and IP can slow practical substitution:

• Process patents that force design-around
• Regulatory CMC barriers that extend approval timelines
• Quality systems and batch consistency requirements for scale-up

What litigation affects PEMFEXY and how does it translate into financial volatility?

Patent litigation creates financial uncertainty through:

• Potential injunctions that block launch
• Revisions to settlement dates based on court timelines
• Appeal-driven extensions that push competition out

How does litigation timeline map to brand revenue?

• Early litigation with stays usually delays launch, supporting revenue stability
• Late-stage rulings can trigger accelerated competition late in the brand lifecycle
• Appeals can reintroduce volatility near the final entry window

Market dynamics: how pricing, contracting, and site-of-care shift PEMFEXY revenue

Oncology branded drugs often experience:

• First-year adoption based on clinical demand
• Mid-cycle pricing pressure from contracting and budget impact assessments
• Late-cycle rebates acceleration and more aggressive prior authorization to manage utilization

Key variables that determine net sales trajectory

• SSI (share of injectable/infusion pipeline) and GPO contracting
• Hospital formulary committees and oncology pharmacy procurement practices
• Acquisition or distribution channel structure (direct vs wholesaler)
• Patient assistance mix and insured demand retention

Financial trajectory: what to expect in margins and cash flow

Brand margin compression is typically driven by:

• Higher rebates and discounts
• Increased SG&A for payer contracting and lifecycle management
• Lower realized price after competitor entry
• Potential impairment or inventory adjustments if demand shifts ahead of generic launch

Revenue pattern typically observed in oncology lifecycle

• Launch ramp: volume-driven growth
• Plateau: steady demand and contract normalization
• Decline: price erosion after generic or therapy switching
• Post-entry: margin reset depending on number of entrants and durability of patient switching barriers

Key Takeaways

• PEMFEXY’s financial trajectory is primarily determined by exclusivity and patent-driven generic entry timing, plus payer contracting dynamics that control net price and covered patient volume.
• Patent estate strength and Orange Book breadth typically dictate whether revenue declines in a slow step-down pattern or a rapid cliff.
• Paragraph IV challenges and settlement agreements can convert uncertain litigation into predictable launch schedules, creating identifiable inflection points in net sales.
• Competitor capability and contracting strength often decide whether market share loss is gradual or immediate at first entry.
• Formulation and method-of-use protection can extend therapeutic relevance and reduce substitution impact even after some patent expiry.

FAQs

1. How do Paragraph IV filings for PEMFEXY change the earliest possible generic launch date?
2. What Orange Book patent expirations for PEMFEXY most affect product substitution versus label carve-outs?
3. How does payer prior authorization typically impact PEMFEXY net sales after competitor entry?
4. What settlement terms commonly delay PEMFEXY generic competition and for how long?
5. Which competitive factors usually drive patient switching away from PEMFEXY once generics enter?

References

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
2. U.S. Food and Drug Administration. “Guidance for Industry: Patent Listings, Exclusivity, and the Orange Book.” U.S. FDA.
3. U.S. FDA. “Drug Approval and Databases.” U.S. Food and Drug Administration.
4. 21 U.S.C. § 355. “Drugs for which new applications are required.” U.S. Government Publishing Office.