VINCASAR PFS Drug Patent Profile
Which patents cover Vincasar Pfs, and when can generic versions of Vincasar Pfs launch?
Vincasar Pfs is a drug marketed by Teva Parenteral and is included in one NDA.
The generic ingredient in VINCASAR PFS is vincristine sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vincristine sulfate profile page.
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Questions you can ask:
- What is the 5 year forecast for VINCASAR PFS?
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- What is Average Wholesale Price for VINCASAR PFS?
Summary for VINCASAR PFS
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 45 |
| Clinical Trials: | 93 |
| Patent Applications: | 2,885 |
| DailyMed Link: | VINCASAR PFS at DailyMed |
Recent Clinical Trials for VINCASAR PFS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | Phase 1 |
| Yazeed Sawalha | Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
US Patents and Regulatory Information for VINCASAR PFS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Parenteral | VINCASAR PFS | vincristine sulfate | INJECTABLE;INJECTION | 071426-001 | Jul 17, 1987 | DISCN | No | 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 |
VINCASAR PFS Market Dynamics, Patent Position, FDA Status, and Financial Trajectory
Vincasar PFS is a generic, preservative-free vincristine sulfate injection marketed by Teva Pharmaceuticals USA. Its commercial profile is defined by an old active ingredient, no meaningful remaining molecule-level exclusivity, limited public revenue disclosure, and high manufacturing sensitivity associated with sterile oncology injectables. The product has durable clinical demand but modest pricing power and significant supply-chain exposure.
What is Vincasar PFS and who markets it?
Vincasar PFS is vincristine sulfate injection, USP, supplied as a preservative-free injectable product. It is administered intravenously for hematologic malignancies and certain pediatric and solid-tumor cancers.
| Product attribute | Detail |
|---|---|
| Brand | Vincasar PFS |
| Active ingredient | Vincristine sulfate |
| Dosage form | Preservative-free sterile injection |
| Therapeutic class | Vinca alkaloid antineoplastic |
| Primary sponsor/labeler | Teva Pharmaceuticals USA, Inc. |
| FDA application | NDA 018581 |
| Regulatory category | Older approved drug with generic-market characteristics |
| Administration | Intravenous only |
| Main clinical uses | Acute lymphoblastic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, neuroblastoma, Wilms tumor, rhabdomyosarcoma and other malignancies |
| Biosimilar relevance | None; vincristine is a small-molecule drug |
The product is distinct from Marqibo, a liposomal vincristine sulfate product approved for relapsed acute lymphoblastic leukemia. Marqibo has a different formulation, clinical positioning and patent profile.
What is the FDA regulatory status of Vincasar PFS?
Vincasar PFS is regulated as an approved vincristine sulfate injection product under FDA application NDA 018581. The FDA-approved labeling identifies intravenous administration and includes boxed warnings addressing fatal medication errors, extravasation and neurotoxicity risks.[1]
The product’s regulatory value comes from continued approval and manufacturing authorization rather than from new-drug exclusivity. Vincristine sulfate was approved decades ago, and the active ingredient is widely established in oncology practice.
What are the FDA-approved uses?
The approved label covers vincristine sulfate use in combination chemotherapy and, in selected settings, as part of treatment regimens for:
- Acute lymphoblastic leukemia
- Hodgkin disease
- Non-Hodgkin lymphoma
- Neuroblastoma
- Wilms tumor
- Rhabdomyosarcoma
- Other malignancies where vincristine is clinically appropriate
Clinical use is highly protocol-driven. Demand is tied to pediatric oncology, hematology treatment pathways and hospital formularies rather than consumer prescribing.
Does Vincasar PFS have FDA exclusivity?
No meaningful new-drug exclusivity remains for Vincasar PFS. Its commercial protection is based on regulatory approval, manufacturing capability, customer relationships and supply reliability.
The product does not depend on:
- New chemical entity exclusivity
- Orphan-drug exclusivity
- Pediatric exclusivity
- A current branded-drug launch cycle
- Biosimilar interchangeability protection
The exact status of any individual product listing should be checked against current FDA databases because marketing and supply status can change without changing the underlying historical approval.
What patents protect Vincasar PFS?
Publicly available product information does not indicate an active patent estate that materially protects vincristine sulfate itself or the conventional Vincasar PFS injection. Vincristine is an old natural-product-derived cytotoxic agent, and composition-of-matter protection has expired.
| Patent category | Relevance to Vincasar PFS |
|---|---|
| Vincristine composition patent | Expired |
| Conventional vincristine injection patent | No material active protection identified |
| Formulation patent | No material active protection identified for standard Vincasar PFS |
| Method-of-use patent | No material product-specific exclusivity identified |
| Manufacturing patent | Potential process know-how may exist, but it is not equivalent to market exclusivity |
| Marqibo liposomal formulation patents | Relevant to Marqibo, not conventional Vincasar PFS |
Are formulation patents protecting Vincasar PFS?
The conventional product does not appear to rely on a proprietary delivery system comparable to liposomal vincristine. Its commercial formulation is a sterile, preservative-free vincristine sulfate injection. The primary barriers are sterile manufacturing, quality control, hazardous-drug handling and reliable distribution.
A manufacturing process can create practical difficulty for competitors without creating a blocking patent position. This distinction matters for valuation. Vincasar PFS has operational barriers, not a strong patent moat.
Are there method-of-use patents for Vincasar PFS?
No product-specific method-of-use patent has been identified as a material barrier to generic competition. Vincristine is used across established oncology regimens, and treatment protocols are generally supported by clinical guidelines, institutional practice and long-standing medical literature rather than enforceable exclusivity around Vincasar PFS.
When does Vincasar PFS lose exclusivity?
Vincasar PFS has already lost the exclusivity associated with a new molecular entity. The relevant commercial question is not a future loss-of-exclusivity event but whether competing manufacturers can maintain approved sterile injectable capacity.
Unlike a recently launched oral oncology product, Vincasar PFS does not face a single patent cliff. Its market has been open to generic competition for many years.
What is the Orange Book status of Vincasar PFS?
The FDA Orange Book identifies approved drug applications and patent information submitted by sponsors. For an old generic-market injectable such as Vincasar PFS, the commercial analysis centers on application status and listed patents rather than an approaching Orange Book patent expiry.
No active Orange Book patent position has been identified that would provide Teva with a meaningful period of exclusivity for conventional Vincasar PFS. The absence of a blocking patent does not guarantee immediate supply from a new entrant because ANDA development and sterile manufacturing validation remain costly.
How many competitors make vincristine sulfate injection?
The competitive field has historically included Teva and other generic or authorized manufacturers, with availability changing over time because of supply interruptions, contract manufacturing decisions and product discontinuations.
The market is structurally concentrated relative to the age of the molecule. A small number of facilities may supply a large share of hospital demand. That concentration creates a mismatch:
- Patent barriers are low.
- Manufacturing barriers are high.
- Demand is stable but not large enough to support many manufacturers.
- Buyers are highly price-sensitive.
- Hospitals require dependable delivery because vincristine is difficult to substitute within established protocols.
The relevant competitors are manufacturers of conventional vincristine sulfate injection, not manufacturers of unrelated vinca alkaloids such as vinblastine or vinorelbine. Marqibo competes only in narrower clinical circumstances because its formulation and approved indication differ.
What patent litigation affects Vincasar PFS?
No material patent litigation involving conventional Vincasar PFS has been identified as a current driver of market access or revenue. The product’s age and generic status make Paragraph IV litigation less commercially significant than in newer branded products.
Are there Paragraph IV challenges?
A Paragraph IV challenge generally concerns an ANDA applicant asserting that a listed patent is invalid, unenforceable or not infringed. Because conventional vincristine sulfate injection does not appear to have a material active patent barrier, a major Paragraph IV dispute is not central to the Vincasar PFS market.
Generic competition can enter through ordinary ANDA pathways where no blocking patent prevents approval. The principal risks are regulatory approval, facility qualification, product quality and commercial viability.
Are there settlement agreements?
No material settlement agreement involving Vincasar PFS and a patent challenger has been identified as shaping current market entry. Any historical commercial arrangements would not change the broader conclusion that conventional vincristine sulfate injection is an open, generic market.
What supply shortages affect Vincasar PFS?
Vincristine has experienced shortage pressure in the U.S. market. In 2019, Pfizer reported a shortage of vincristine sulfate injection, and the disruption affected pediatric and adult oncology treatment planning.[2] FDA and professional-society shortage resources have treated vincristine as a clinically important injectable with limited near-term substitution options.[3]
Shortage exposure results from:
- Dependence on a small number of sterile injectable facilities.
- Low unit prices that limit investment incentives.
- Complex quality requirements for cytotoxic products.
- Batch failures or manufacturing delays.
- Hospital inventory practices and allocation systems.
- Difficulty replacing one approved presentation with another quickly.
The shortage history increases the strategic value of reliable supply. It does not create patent exclusivity, but it can improve the commercial position of a manufacturer that maintains consistent availability.
What is the financial trajectory of Vincasar PFS?
Teva does not publicly report Vincasar PFS revenue as a standalone product. The company reports financial performance at broader segment and portfolio levels, including its generics business. Product-level revenue, gross margin and unit-volume data for Vincasar PFS are not separately disclosed in Teva’s public annual reporting.[4]
The likely financial trajectory is therefore best described through market structure rather than a reported sales series.
| Financial driver | Expected effect on Vincasar PFS |
|---|---|
| Mature generic status | Limits pricing power |
| Stable oncology demand | Supports recurring volume |
| No patent expiry cliff | Reduces abrupt revenue collapse risk |
| Multiple competitors | Pressures price and share |
| Sterile manufacturing constraints | Supports occasional price increases during shortages |
| Hospital purchasing | Creates tender and contract pressure |
| Low unit value | Limits margin expansion |
| Supply reliability | Can preserve share and improve account retention |
| Product discontinuation risk | Can shift demand rapidly to remaining suppliers |
Revenue trajectory
The product’s revenue is likely mature and volume-led rather than growth-led. The most probable pattern is:
- Long-term demand stability based on continued treatment need.
- Price erosion during periods of normal supply.
- Temporary revenue and pricing improvement during competitor shortages.
- Share volatility when manufacturers discontinue presentations or experience quality events.
- Limited opportunity for durable premium pricing without a differentiated formulation or supply guarantee.
A shortage can increase shipment value, but it does not necessarily improve long-term profitability. Expedited manufacturing, allocation management, quality remediation and regulatory commitments can raise costs at the same time that realized prices increase.
Margin trajectory
Margins are constrained by generic oncology economics. The principal cost drivers include:
- Active pharmaceutical ingredient procurement
- Aseptic filling
- Sterility testing
- Container-closure integrity testing
- Hazardous-drug controls
- Quality systems
- Cold-chain or controlled distribution requirements
- Regulatory compliance
- Inventory reserves for short-dated oncology products
The product can be commercially rational for a large manufacturer with existing sterile-injectable infrastructure. It is less attractive for a new entrant that must build dedicated capability for a low-price, mature product.
How strong is the patent estate for Vincasar PFS?
The patent estate is weak. Commercial defensibility depends on manufacturing execution and customer access.
| Strength factor | Assessment |
|---|---|
| Composition-of-matter protection | None of practical relevance |
| Product formulation protection | Weak |
| Method-of-use protection | Weak |
| Regulatory exclusivity | None of practical relevance |
| Manufacturing know-how | Moderate practical importance |
| Sterile-facility capability | High practical importance |
| Hospital contracting | Moderate commercial importance |
| Supply reliability | High commercial importance |
| Switching friction | Moderate, especially during shortages |
For investors or licensing teams, Vincasar PFS should be valued as a supply-constrained generic injectable, not as a patent-protected oncology asset.
What licensing deals involve Vincasar PFS?
No major public licensing transaction specifically centered on Vincasar PFS has been identified. Teva’s broader generic portfolio and corporate acquisitions have included sterile injectable products, but public filings do not provide a standalone valuation or royalty stream for Vincasar PFS.[4]
A potential transaction involving the product would likely be evaluated on:
- FDA application ownership
- Current marketing status
- Approved presentations
- Manufacturing site and contract-manufacturing rights
- Historical shortage performance
- Hospital contracts
- Product profitability after manufacturing and distribution costs
- Any regulatory commitments or unresolved quality matters
Because no identifiable patent royalty stream supports the product, transaction value would depend mainly on cash flow, supply access and portfolio fit.
What generic launch risks exist for Vincasar PFS?
A new entrant faces low legal entry barriers but meaningful execution risks.
Regulatory and manufacturing risks
The most important risks are:
- Failure to validate aseptic production
- Sterility or particulate contamination
- Inability to secure reliable vincristine sulfate API
- Delays in FDA inspection or remediation
- Container-closure failures
- Inadequate stability data
- Inability to support multiple vial or concentration presentations
- Product recalls or voluntary discontinuation
Commercial launch risks
A new supplier may obtain FDA approval and still fail commercially if it cannot secure hospital contracts or maintain dependable inventory. Buyers generally prefer a supplier with a record of continuity, especially after prior vincristine shortages.
The absence of patents means a launch can be legally straightforward. It does not make the market economically attractive. The addressable revenue pool is limited, and price competition can reduce returns quickly.
How does Vincasar PFS compare with Marqibo?
| Factor | Vincasar PFS | Marqibo |
|---|---|---|
| Active ingredient | Vincristine sulfate | Vincristine sulfate |
| Formulation | Conventional preservative-free injection | Liposomal injection |
| Sponsor profile | Generic-market product | Branded specialty product |
| Primary market | Broad oncology protocols | Narrower relapsed acute lymphoblastic leukemia use |
| Patent position | Weak or expired | Product-specific protection may be relevant |
| Pricing | Generic pricing | Branded specialty pricing |
| Regulatory pathway | Older approved product | Newer formulation approval |
| Biosimilar status | Not applicable | Not a biosimilar market |
| Main defense | Supply and manufacturing | Formulation, indication and specialty commercialization |
The two products should not be treated as interchangeable assets in a patent or valuation analysis. Marqibo’s differentiated formulation changes its regulatory and commercial profile.
Key Takeaways
- Vincasar PFS is a mature vincristine sulfate injection product marketed by Teva.
- It has no material remaining new-drug or composition-of-matter exclusivity.
- No active patent estate has been identified that materially blocks conventional vincristine sulfate injection competition.
- The product is not exposed to biosimilar substitution because vincristine is a small molecule.
- Revenue and margin data are not disclosed separately by Teva.
- Financial performance is likely driven by stable oncology demand, generic price pressure and episodic shortage-related supply advantages.
- Sterile manufacturing, quality compliance and supply reliability are more important than patents.
- Historical vincristine shortages demonstrate the market’s dependence on a small number of manufacturers.
- A new entrant faces limited patent risk but substantial aseptic manufacturing and commercial execution risk.
- Marqibo is a separate liposomal vincristine product with a different regulatory and patent profile.
FAQs
Is Vincasar PFS still commercially protected?
No. The conventional product does not appear to have meaningful remaining molecule-level or formulation exclusivity. Its commercial protection comes from manufacturing capability and supply reliability.
Is Vincasar PFS interchangeable with Marqibo?
No. Marqibo is a liposomal vincristine formulation approved for a narrower indication. It is not simply an interchangeable generic version of conventional Vincasar PFS.
Does Teva disclose Vincasar PFS sales?
No standalone Vincasar PFS revenue, unit volume or margin figure is reported in Teva’s public financial statements. The product is included within broader generic pharmaceutical reporting.
Can a generic manufacturer launch another vincristine injection?
Potentially, subject to FDA approval and compliance with sterile injectable manufacturing requirements. The principal barriers are facility validation, quality control, API supply and commercial economics rather than patent exclusivity.
Why can an old generic oncology drug remain strategically important?
Vincristine remains embedded in established cancer treatment protocols. Even with limited pricing power, supply interruptions can create significant clinical and commercial consequences because hospitals may have few practical substitutes.
References
- U.S. Food and Drug Administration. (2023). Vincasar PFS: Vincristine sulfate injection, USP prescribing information. Teva Pharmaceuticals USA, Inc.
- U.S. Food and Drug Administration. (2019). FDA statement on drug shortages and vincristine sulfate injection availability.
- American Society of Health-System Pharmacists. (2019). ASHP drug shortages: Vincristine sulfate injection.
- Teva Pharmaceutical Industries Ltd. (2024). Annual report and Form 20-F.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
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