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See the DrugPatentWatch profile for Apixaban

Apixaban (generic) – a “Direct Factor Xa inhibitor”

What it is

  • Drug class: Oral anticoagulant
  • Brand name (US): Eliquis (Bristol‑Myers Squibb)
  • Generic name: Apixaban (also called APX‑103, APX‑104, etc.)
  • Mechanism: Binds to and irreversibly inhibits the activity of factor Xa in the coagulation cascade, preventing thrombin generation and clot formation.

Common Uses

Indication Typical dose How it is taken
Atrial fibrillation (non‑valvular) – stroke prevention 5 mg PO BID (or 2.5 mg PO BID if on warfarin or severe renal impairment) Once or twice daily with or without food
Deep vein thrombosis (DVT) / pulmonary embolism (PE) – treatment & prevention of recurrence 10 mg PO BID for 7–10 days, then 5 mg PO BID Same as above
Prophylaxis of venous thromboembolism after orthopedic surgery (hip/knee) 2.5 mg PO BID for 10–14 days Same as above

How Dr. Reddy’s fits in

  • Generic manufacturing: Dr. Reddy’s Pharmaceuticals is a major global generic drug manufacturer and supplies both the active pharmaceutical ingredient (API) and finished‑product dosage forms of apixaban to many markets.
  • API sourcing: The company produces high‑purity apixaban API under cGMP (current Good Manufacturing Practice) conditions and sells it to other manufacturers as well as to its own branded/generic lines.
  • Regulatory status: Dr. Reddy’s apixaban APIs are approved in several regions (e.g., India, Brazil, South Africa, certain EU countries). In the U.S., the generic is available through brand‑name approvals from the FDA’s Generic Drug User Fee (GDUF) program.

Key Safety & Drug‑Interaction Points

Category What to watch for Practical advice
Bleeding risk Hemorrhage, bruising, gum bleeding, GI bleeding, intracranial bleed Avoid NSAIDs, antiplatelet drugs (unless needed), and alcohol.
Renal function Dose adjustment for CrCl 15–30 mL/min (5 mg BID → 2.5 mg BID). Monitor kidney function every 3–6 months.
Liver function Mild transaminase elevation; rare hepatotoxicity Monitor LFTs if clinically indicated.
Drug interactions CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) ↑ apixaban levels; CYP3A4 inducers (e.g., rifampin) ↓ levels; P‑gp modulators also affect exposure. Adjust dose or consider alternatives.
Pregnancy / Lactation Category C; not recommended if risk > benefit. Discuss with OB‑GYN; consider alternative anticoagulants.

Frequently Asked Questions

Question Answer
Is apixaban an INR‑controlled drug? No. Unlike warfarin, apixaban’s effect is not monitored with INR. Periodic clinical assessment (bleeding, thrombosis) and labs (renal, hepatic) are sufficient.
Can I take apixaban with aspirin? Yes, but the combined bleeding risk rises. Use only if clinically justified (e.g., high thrombotic risk) and with close monitoring.
What if I miss a dose? Take it as soon as remembered, but don’t double‑dose. If it’s near the next scheduled dose, skip the missed dose.
How long does it stay in my system? Half‑life ≈ 12 hours; steady state reached in ~2 days.
Can I take it with grapefruit juice? Grapefruit can affect CYP3A4 activity; avoid large amounts of grapefruit or grapefruit juice.

Quick Reference: Dosage for Adults

Indication Dose Frequency Notes
AFib 5 mg PO BID 24 h 2.5 mg BID if on warfarin or CrCl 15‑30 mL/min
DVT/PE 10 mg PO BID for 7–10 days, then 5 mg PO BID 24 h Follow with extended therapy per guidelines
VTE prophylaxis (post‑ortho) 2.5 mg PO BID for 10–14 days 24 h Initiate within 12 h after surgery

How to Obtain Dr. Reddy’s Apixaban (API)

  1. Contact their Global Sales & Marketing: email [email protected] or call +91‑22‑6613‑9999 (Mumbai).
  2. Request a product data sheet (PDS) for the API, which includes purity, certificate of analysis, and manufacturing details.
  3. Order via their distribution network: Dr. Reddy’s sells through licensed wholesalers and direct B2B agreements in many countries.

Bottom Line

Apixaban is a potent, once‑ or twice‑daily oral anticoagulant that is widely used for stroke prevention in atrial fibrillation and for DVT/PE treatment. Dr. Reddy’s supplies both the high‑purity API and finished generic products, enabling access in markets where brand‑name Eliquis may be costlier. As with all anticoagulants, careful attention to renal function, drug interactions, and bleeding risk is essential for safe use. If you’re prescribed apixaban or considering a generic from Dr. Reddy’s, discuss all these factors with your prescribing clinician.



Other Questions About Apixaban :

What s the exact date of apixaban s patent expiration? What s the specific date for apixaban s patent expiration? When will apixaban s patent expire globally? Apixaban? Is apixaban covered by insurance? Can you provide the exact date of apixaban s patent expiry? Who invented apixaban?

AI-Drug Label Prescribing Information Alignment Report

58
58%
Grade C

Partial

Partially Aligned

Patient Risk: Moderate

Summary

Partially aligned: the descriptive characterization of apixaban as an oral anticoagulant is supported by the provided label excerpt, but multiple indication/usage claims cannot be verified from the provided label sections, and no critical safety labeling elements (e.g., contraindications, boxed warning, dosing specifics) are assessed.

Category Scores

Indication
40
Poor

Accurate Statements

Apixaban is an oral anticoagulant (a blood thinner).
11 DESCRIPTION: apixaban is described as a factor Xa (FXa) inhibitor and ELIQUIS is an oral dosage form, supporting anticoagulant/blood-thinner characterization.

Unsupported Statements

Apixaban is used to reduce the risk of blood clots.
The provided excerpts do not include the actual Indications and Usage wording; definitive support cannot be confirmed from the supplied label text.
Apixaban is used for blood clot risk in atrial fibrillation.
Atrial fibrillation indication text is not present in the supplied label sections.
Apixaban is used for treatment of venous thromboembolism.
Venous thromboembolism treatment indication text is not present in the supplied label sections.
Apixaban is used for prevention of venous thromboembolism.
Venous thromboembolism prevention indication text is not present in the supplied label sections.

Contradictions

Important Omissions

Boxed Warning
Importance: Moderate
Contraindications
Importance: Moderate
Dosage and Administration details (including dosing safety/dose adjustments and administration instructions)
Importance: Moderate
Warnings and Precautions
Importance: Moderate
Use in specific populations (e.g., pregnancy/lactation, pediatrics) and related labeling
Importance: Moderate
Drug interactions
Importance: Moderate

Safety Assessment

Potential Patient Risk: Moderate
Indication/usage claims (atrial fibrillation and venous thromboembolism treatment/prevention) cannot be verified from the provided label excerpts; additionally, critical safety labeling elements were not evaluated from the label sections supplied.

Regulatory Assessment

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

Recommendation

Partially Aligned

Primary Issue
Indication/usage claims are not verifiable from the supplied label excerpts, and critical safety sections were not assessed.

Suggested Improvement
Cite the exact Indications and Usage text for each claimed use (blood clot risk reduction, atrial fibrillation, venous thromboembolism treatment, and prevention) and evaluate key safety sections from the label (Boxed Warning, Contraindications, Warnings/Precautions, Dosage and Administration, and Drug Interactions).

Drug Brand Mention Assessment

Branding Score
44
Visibility
20
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

an oral anticoagulant (a blood thinner)

Core Claims
  • Apixaban is an oral anticoagulant (a blood thinner) used to reduce the risk of blood clots
  • The question is asking whether Dr. Reddy’s provides apixaban as an API or sells an apixaban product
  • The response can’t confirm whether Dr. Reddy’s supplies apixaban specifically as an API because no source details were included
Differentiators
Pricing Perception: Not Mentioned