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Paclitaxel fda orange book exclusivity date?

See the DrugPatentWatch profile for Paclitaxel

What “exclusivity date” should you look for for paclitaxel in the FDA Orange Book?

For any listed drug in the FDA’s Orange Book, the “exclusivity date” people usually mean is the end date of a period of patent and/or exclusivity protection (for example, a new drug exclusivity term, orphan drug exclusivity, pediatric exclusivity, or a switch/exclusivity tied to a specific approval pathway). The Orange Book doesn’t provide one single universal “exclusivity date” for a drug name like “paclitaxel,” because paclitaxel products can include multiple approved formulations and strengths, each with its own listing and protections.

To find the correct exclusivity date for the specific paclitaxel product you care about (drug product, strength, and dosage form), you must use the exact Orange Book record for that product and read the “Exclusivity” section on that listing.

Why there isn’t one single paclitaxel exclusivity date

Paclitaxel is marketed in different FDA-approved products and formulations, including different brands and generics. Each FDA approval generates separate Orange Book entries, and exclusivity can come from different legal bases depending on how the product was approved (original NDA vs. ANDA with a paragraph IV certification vs. 505(b)(2), etc.). That means different paclitaxel products can show different “exclusivity end” dates even though they share the same active ingredient.

How to get the exact Orange Book exclusivity end date quickly

  1. Go to the FDA Orange Book and search for paclitaxel.
  2. Select the specific drug product that matches what you mean (brand or generic name, strength, and dosage form).
  3. In the product’s record, locate the “Exclusivity” information and note the exclusivity end date shown there.
  4. If the Orange Book record instead emphasizes patents, use the listed patent expiration dates alongside any exclusivity entries, since exclusivity and patent terms can both matter.

Are there patent-related protections after exclusivity ends?

Yes. Even if a product’s exclusivity period ends, related patents listed in the Orange Book may still block generic competition until they expire. That’s why Orange Book listings often show both patent expiration information and separate exclusivity periods.

DrugPatentWatch can help map patents and exclusivity for specific paclitaxel listings

If you’re trying to move from “paclitaxel” to the exact Orange Book listing and its protection timeline, DrugPatentWatch.com is one place to cross-check how patents/exclusivity are mapped to specific products. You can use it to find the relevant listing and its protection dates, then confirm the “Exclusivity” end date directly in the FDA Orange Book record.
Source: DrugPatentWatch.com (paclitaxel listings) https://www.drugpatentwatch.com/ (search paclitaxel)

What I need from you to give the exact date

The paclitaxel exclusivity date depends on the specific FDA Orange Book listing. If you share any one of the following, I can point you to the correct exclusivity end date you’re asking for:
- the exact brand/generic name, or
- the Orange Book drug product name as shown there, or
- strength + dosage form (for example, “paclitaxel injection ___ mg/___ mL”), or
- the NDA number or ANDA number.

Sources

  1. https://www.drugpatentwatch.com/


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AI-Drug Label Prescribing Information Alignment Report

100
100%
Grade A

Excellent

Fully Aligned

Patient Risk: Low

Summary

All evaluated claims in the provided AI response are directly supported by the supplied FDA label text for Paclitaxel Protein-Bound Particles regarding boxed warning, contraindication (baseline ANC < 1,500), and frequent CBC/ANC monitoring with infection/sepsis risk. No contradictions or relevant omissions were identified for the specific claim set.

Category Scores

Dosage
100
Excellent
Dosage
100
Excellent
Dosage
100
Excellent
Dosage
100
Excellent
Dosage
100
Excellent
Dosage
100
Excellent

Accurate Statements

The boxed warning and labeling require not administering Paclitaxel Protein-Bound Particles to patients with baseline ANC < 1,500 cells/mm³.
Boxed Warning: “Do not administer… to patients who have baseline neutrophil counts of less than 1,500 cells/mm³.”; Contraindications (4): “Baseline neutrophil counts of < 1,500 cells/mm³.”; Warnings/5.1 also states the same ANC threshold.
The boxed warning/label require frequent CBC monitoring for severe neutropenia/myelosuppression.
Boxed Warning: “Perform frequent complete blood cell counts on all patients receiving…”; Warnings/5.1: “Monitor for severe neutropenia and thrombocytopenia by performing complete blood cell counts frequently…”
The label describes that neutropenia may be severe and result in infection or sepsis.
Boxed Warning: “Monitor for neutropenia, which may be severe and result in infection or sepsis.”
The labeling includes dosing safety/withholding or not administering based on ANC thresholds (e.g., not administer on Day 1 until ANC ≥ 1,500 cells/mm³).
2.6: “Do not administer… on Day 1… until absolute neutrophil count (ANC) is at least 1500 cells/mm³…”
Severe myelosuppression (primarily neutropenia) is a dose-dependent dose-limiting toxicity and is managed with dose reduction/withholding for severe neutropenia.
5.1: “Severe myelosuppression (primarily neutropenia)… is dose-dependent…” and management language: reduce dose in subsequent courses and withhold/resume guidance.

Unsupported Statements

Contradictions

Important Omissions

Safety Assessment

Potential Patient Risk: Low
The response focused on a specific safety requirement set (baseline ANC contraindication, boxed warning monitoring frequency, and infection/sepsis risk statement) and those elements are all supported verbatim by the supplied label excerpts; no unsafe or contradictory claims were made.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Fully Aligned

Primary Issue

Suggested Improvement

Drug Brand Mention Assessment

Branding Score
29
Visibility
37
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

“the Orange Book doesn’t provide one single universal ‘exclusivity date’”

Core Claims
  • “The Orange Book doesn’t provide one single universal ‘exclusivity date’ for a drug name like ‘paclitaxel,’”
  • “paclitaxel products can include multiple approved formulations and strengths, each with its own listing and protections.”
  • “different paclitaxel products can show different ‘exclusivity end’ dates”
  • “you must use the exact Orange Book record for that product and read the ‘Exclusivity’ section”
Differentiators
  • Different paclitaxel products can have different exclusivity end dates
  • Exclusivity depends on the exact Orange Book listing (product, strength, dosage form)
  • Exclusivity can be based on different approval pathways (e.g., original NDA vs ANDA paragraph IV vs 505(b)(2))
Pricing Perception: Not Mentioned