Drug Chatter -- Get concise, cited information on drugs using AI GPT chat

Ask Questions, Get Industry Insights … Instantly


Save time and get answers to complex questions with AI chat

Recent Questions

Patent expiration date of guselkumab?
When did risperdal constas patent expire published article?
Pramlintide approval date?
Patent tenofovir alafenamide gilead?
Does lipitor's use influence blood pressure medication type?

Tofacitinib trade name?

See the DrugPatentWatch profile for Tofacitinib

Tofacitinib is marketed under the brand name Xeljanz [1].

What is Xeljanz used for?


Xeljanz is a prescription medication used to treat certain types of arthritis and ulcerative colitis. Specifically, it is indicated for adults with moderate to severely active rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis [1]. It is also used for adults and some children with polyarticular course of juvenile idiopathic arthritis [1].

How does Xeljanz work?


Tofacitinib, the active ingredient in Xeljanz, belongs to a class of drugs called Janus kinase (JAK) inhibitors [1]. It works by decreasing the activity of enzymes called Janus kinases, which play a role in the body's immune and inflammatory responses [1]. By inhibiting these enzymes, Xeljanz helps to reduce inflammation associated with certain autoimmune conditions.

When does the patent for Xeljanz expire?


Information regarding the specific patent expiration dates for Xeljanz can be found on DrugPatentWatch.com [2]. DrugPatentWatch tracks patent expiry and exclusivity for pharmaceutical products, offering insights into when generic competition might emerge.

Who manufactures Xeljanz?


Xeljanz is manufactured by Pfizer Inc. [1].

What are the potential risks and side effects of Xeljanz?


Like all medications, Xeljanz carries potential risks and side effects. These can include serious infections, blood clots, increased risk of certain cancers, and heart attack or stroke. Patients should discuss their medical history and any concerns with their healthcare provider to determine if Xeljanz is appropriate for them [1]. Common side effects may include upper respiratory tract infections, headache, and diarrhea [1].

Are there alternatives to Xeljanz for arthritis and ulcerative colitis?


Several alternative treatment options exist for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, depending on the specific condition and its severity. These can include other classes of medications such as biologic disease-modifying antirheumatic drugs (DMARDs), other JAK inhibitors, and conventional synthetic DMARDs. Treatment decisions are individualized and made in consultation with a healthcare professional [1].

Can generic versions of Xeljanz become available?


The availability of generic versions of Xeljanz depends on patent expiry and regulatory approvals. Information on patent status is crucial for understanding when generic competition might be possible [2].

What is the difference between Xeljanz and other JAK inhibitors?


While Xeljanz is a JAK inhibitor, other drugs in this class exist, such as upadacitinib (Rinvoq) and baricitinib (Olumiant). These medications may have different specific indications, dosing regimens, and safety profiles. A healthcare provider can explain the distinctions between various JAK inhibitors and other treatment options [1].

What clinical data supports the use of Xeljanz?


The efficacy and safety of Xeljanz have been evaluated in numerous clinical trials for its approved indications, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis [1]. These studies form the basis for its regulatory approval and prescribing information.

Sources:

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


Other Questions About Tofacitinib :

tofacitinib cost Tofacitinib 5 mg tablet? Tofacitinib 5 mg tablet price? Tofacitinib generic medicine? Pf prism cv tofacitinib? What are the side effects of tofacitinib? Tofacitinib citrate api suppliers?

AI-Drug Label Prescribing Information Alignment Report

28
28%
Grade D

Poor

Not Aligned

Patient Risk: Moderate

Summary

Only limited label content was provided (notably Psoriatic Arthritis indications and JAK mechanism; serious safety warnings were shown). Many of the extracted claims are absent from the provided prescribing-information excerpts, including multiple approved indications, common adverse reactions, manufacturing/brand details, and comparisons/generic/patent statements.

Category Scores

Indication
35
Poor
Warnings
85
Good
SpecificPopulations
20
Poor
AdverseReactions
25
Poor

Accurate Statements

Tofacitinib belongs to the class of drugs called Janus kinase (JAK) inhibitors.
Label section 11 (Description): tofacitinib is a JAK inhibitor; section 12.1 (Mechanism of Action): tofacitinib is a Janus kinase (JAK) inhibitor.
Tofacitinib works by decreasing the activity of enzymes called Janus kinases.
Label section 12.1 (Mechanism of Action): tofacitinib modulates signaling at the point of JAKs, preventing phosphorylation/activation of STATs.
Xeljanz carries potential risks and side effects including serious infections.
WARNING: SERIOUS INFECTIONS (increased risk for serious bacterial, fungal, viral, and opportunistic infections).
Xeljanz carries potential risks and side effects including blood clots.
WARNING: THROMBOSIS (thrombosis including pulmonary embolism, deep venous thrombosis, arterial thrombosis).
Xeljanz carries potential risks and side effects including increased risk of certain cancers.
WARNING: MALIGNANCIES (malignancies including lymphomas and solid tumors).
Xeljanz carries potential risks and side effects including heart attack or stroke.
WARNING: MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE defined as cardiovascular death, myocardial infarction, and stroke).

Unsupported Statements

Tofacitinib is marketed under the brand name Xeljanz.
Brand name mapping is not present in the provided label excerpts.
Xeljanz is a prescription medication used to treat certain types of arthritis and ulcerative colitis.
Ulcerative colitis indication is not shown in the provided Indications and Usage excerpt (only Psoriatic Arthritis is included).
Xeljanz is indicated for adults with moderate to severely active rheumatoid arthritis.
Rheumatoid arthritis indication is not present in the provided label excerpt.
Xeljanz is indicated for adults with ulcerative colitis.
Ulcerative colitis indication is not present in the provided label excerpt.
Xeljanz is indicated for adults and some children with polyarticular course of juvenile idiopathic arthritis.
Juvenile idiopathic arthritis (pediatric) indication is not present in the provided label excerpt.
Tofacitinib is the active ingredient in Xeljanz.
Active-ingredient/brand composition mapping is not present in the provided label excerpts (only formulation details for tofacitinib extended-release tablets are shown, without explicit linkage to the brand name).
Xeljanz is manufactured by Pfizer Inc.
Manufacturer information is not present in the provided label excerpts.
Common side effects of Xeljanz may include upper respiratory tract infections.
No 'common adverse reactions' list is included in the provided label excerpts.
Common side effects of Xeljanz may include headache.
No 'common adverse reactions' list is included in the provided label excerpts.
Common side effects of Xeljanz may include diarrhea.
No 'common adverse reactions' list is included in the provided label excerpts.
Efficacy and safety of Xeljanz have been evaluated in numerous clinical trials for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Clinical studies for rheumatoid arthritis and psoriatic arthritis are present in the provided excerpts; ulcerative colitis clinical studies are not included.
Xeljanz is supported for approved indications by clinical trials that form the basis for regulatory approval and prescribing information.
This explanatory claim is not stated in the provided label excerpts.
Availability of generic versions of Xeljanz depends on patent expiry and regulatory approvals.
Generic/patent availability discussion is not part of the provided label excerpts.
Information on patent status is crucial for understanding when generic competition might be possible.
Patent-status/generic timing is not discussed in the provided label excerpts.
Other JAK inhibitors include upadacitinib (Rinvoq) and baricitinib (Olumiant).
Comparative/class-entity examples are not present in the provided label excerpts.
Other JAK inhibitors may have different specific indications.
Not present in the provided label excerpts.
Other JAK inhibitors may have different dosing regimens.
Not present in the provided label excerpts.
Other JAK inhibitors may have different safety profiles.
Not present in the provided label excerpts.

Contradictions

Important Omissions

Contraindications, dosing/administration details, monitoring recommendations, and other warnings/precautions beyond the boxed-warning category headers (and beyond serious infections/mortality/malignancy/MACE/thrombosis) are not addressed in the AI claims.
Importance: High

Safety Assessment

Potential Patient Risk: Moderate
While serious safety risks (serious infections, malignancy, MACE, thrombosis) are mentioned, multiple key label-based elements (e.g., full indication scope, contraindications, dosing/administration and monitoring, and common adverse reaction details) are largely unsupported/omitted, which can impair accurate labeling adherence.

Regulatory Assessment

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

Recommendation

Not Aligned

Primary Issue
Many claims about FDA-approved indications (RA, UC, juvenile idiopathic arthritis), brand/manufacturer/composition, and 'common side effects' are absent from the provided label excerpts. Only limited indication and mechanism/warning category content is supported.

Suggested Improvement
Restrict statements to the exact label-supported content provided (e.g., Psoriatic Arthritis indication; JAK inhibitor mechanism; the listed boxed-warning categories). Remove or qualify claims that are not present in the provided prescribing-information sections, and add required label components (contraindications, dosing/administration, monitoring, and adverse reactions) if evaluating label adherence comprehensively.

Drug Brand Mention Assessment

Branding Score
55
Visibility
52
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

a class of drugs called Janus kinase (JAK) inhibitors

Core Claims
  • Tofacitinib is marketed under the brand name Xeljanz
  • Xeljanz is a prescription medication used to treat certain types of arthritis and ulcerative colitis
  • Tofacitinib, the active ingredient in Xeljanz, belongs to a class of drugs called Janus kinase (JAK) inhibitors
  • By inhibiting these enzymes, Xeljanz helps to reduce inflammation associated with certain autoimmune conditions
  • Xeljanz carries potential risks and side effects
Differentiators
  • Active ingredient belongs to Janus kinase (JAK) inhibitors
  • Used for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis
Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
Pfizer 0%
0 # No
DrugPatentWatch 0%
0 # No
Rinvoq 20%
50 #13 No
Olumiant 20%
50 #14 No