Apixaban is an orally active inhibitor of coagulation factor xa with anticoagulant activity. Fdas overdue approval of apixaban eliquis is great news. The fda has once again delayed approval of apixaban eliquis, the muchanticipated oral anticoagulant. What are the generic drug sources for apixaban and what is the scope of patent protection apixaban is the generic ingredient in two branded drugs marketed by bionpharma inc.
The new prescription drug user fee act pdufa goal date was announced yesterday by the drugs manufacturers, pfizer and. Jan 03, 20 fdas overdue approval of apixaban eliquis is great news for af patients last week the fda finally approved apixaban eliquis for the prevention of stroke in patients with nonvalvular atrial. Aug 18, 2016 the fda also analyzed data from the ongoing annexa4 study, which the company described as a phase 3b4 singlearm, openlabel confirmatory study in patients receiving apixaban, rivaroxaban. Call your doctor right away if bleeding or bruising is unusual, severe, or cannot be controlled. It does not require antithrombin iii for antithrombotic activity. The concurrent use of apixaban with other anticoagulants, antiplatelet agents, and nonsteroidal antiinflammatory agents is expected to increase the risk of bleeding in comparison to use of apixaban alone. The absorption of apixaban is mediated by pglycoprotein pgp. Apixaban, sold under the brand name eliquis among others, is an anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation. Effect may last for several weeks after discontinuation of inducers of p. Fda accepts eliquis apixaban new drug application for. Fdas overdue approval of apixaban eliquis is great news for af patients last week the fda finally approved apixaban eliquis for the prevention of stroke in patients with nonvalvular atrial. Eliquis apixaban is a prescription anticoagulant, or blood thinner, used to lower the risk of strokes and blood clots in people with an irregular heartbeat known as atrial fibrillation. Approved as the first and only antidote indicated for patients treated with rivaroxaban and apixaban when reversal of anticoagulation.
Jun 25, 2012 the fda has once again delayed approval of apixaban eliquis, the muchanticipated oral anticoagulant. More specifically, apixaban is oral, direct, selective, and. The therapeutic equivalence evaluations in the orange book reflect fdas application of specific criteria to the multisource prescription drug. Approved drug products containing apixaban listed in the fda orange book. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. You can search by active ingredient, proprietary name, applicant, or application number. Eliquis apixaban dose, indications, adverse effects.
Nov 26, 2019 apixaban is metabolized mainly via cyp3a4 with minor contributions from cyp1a2, 2c8, 2c9, 2c19, and 2j2. Approved drug products with therapeutic equivalence. Coagulation factor xa recombinant, inactivatedzhzo andexxaportola. Fda acknowledges receipt of resubmission of the eliquis apixaban new drug application to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Biliary and direct intestinal excretion contributes to elimination of apixaban in the feces. The fda under trump has approved 1,600 generic drugs. Bristolmyers squibb and pfizer announced today that it had received a a complete response. The prescription drug user fee act pdufa goal date for a decision by the fda is march 28, 2012. The fda also analyzed data from the ongoing annexa4 study, which the company described as a phase 3b4 singlearm, openlabel confirmatory study in patients receiving apixaban. There are ascii text files of the orange book drug product, patent, and exclusivity data at the orange book information data files page. Apixaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by. To identify approved drugs that have not reached the market, khn used the fdas orange book database as of jan. In a clinical trial, eliquis was tested against lovenox enoxaparin followed by warfarin lovenox warfarin, a standard treatment, for the first 6 months after dvtpe. The new prescription drug user fee act pdufa goal date was announced yesterday by the drugs manufacturers, pfizer.
On march 23, 2020, fda removed from the orange book the listings for biological products that have been approved in applications under section 505 of the. There are two patents protecting this compound and one paragraph iv challenge. Eliquis blood thinner uses, dosages, interactions and risks. Apixaban absorption was studied in a small n 12, openlabel, 4treatment crossover trial in which subjects received a single dose of apixaban 2. May 15, 2020 eliquis is a drug marketed by bristol myers squibb and is included in one nda. The safety of eliquis was evaluated in the aristotle and averroes studies see clinical studies 14, including 11,284 patients exposed to eliquis 5 mg twice daily and 602. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide 2. Apixaban fda orange book approved drug product list. Downloadable data files for the orange book the the compressed zip data file unzips into three files, whose field descriptions appear below. Apixaban inhibits free and clotbound fxa, and prothrombinase activity.
Aug 02, 2015 special reports slippery slope slippery slope. This medication may also cause you to bruise or bleed more easily. The electronic availability of the orange book brings this valuable tool to the web for healthcare. There are thirty drug master file entries for this. The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug products approved on the basis of safety and. Orange book has 3 patents listed for apixaban, with the earliest expiring 12222019, and two others in 2026 and 2031. The electronic availability of the orange book brings this valuable tool to the web for. It has lost its exclusivity since it was first fda approved december 28, 2012. Apixaban is an anticoagulant blood thinner that reduces blood clotting and reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The concurrent use of apixaban with other anticoagulants, antiplatelet agents, and nonsteroidal antiinflammatory agents is expected to increase the risk of bleeding in. The orange book has long been a reliable resource for information about fda approved drugs. May 11, 2020 apixaban is the generic ingredient in two branded drugs marketed by bionpharma inc, micro labs, mylan, and bristol myers squibb, and is included in four ndas. Fda approves eliquis apixaban to reduce the risk of blood clots following hip or knee replacement surgery princeton, nj and new york, march 14, 2014 bristolmyers squibb company nyse. Fdaapproved indications1,2,3,4 dabigatran, rivaroxaban, and apixaban are indicated for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation af.
Source document contributed to documentcloud by coulter jones medpage today. Apixaban eliquis is an expensive drug used to lower the chance of stroke in people with a medical condition called atrial fibrillation. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for eliquis apixaban skip to. Eliquis apixaban is a factor xa inhibitor anticoagulant indicated to reduce the risk of stroke.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for eliquis apixaban. Eliquis is a drug marketed by bristol myers squibb and is included in one nda. The definitive source for patent expiration dates is the fda orange book at orange book please note that there are 2 types of market protections. It is also used to treat or prevent clots in the lungs or in the veins. The orange book downloadable data files are updated monthly. This drug has one hundred and sixtyfive patent family members in fortythree countries. Safetyrelated labeling change for eliquis apixaban rx drug. Unchanged apixaban is the major drugrelated component in human plasma. Fdas approved drug products with therapeutic equivalence evaluations orange book identifies drug products approved on the basis of safety and. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing. Food and drug administration for eliquis apixaban mar 1, 2012.
The orange book has long been a reliable resource for information about fdaapproved drugs. Apixaban drug interaction potential anticoagulation services. Patent number expiration date 6,4,980 the 980 patent december 22, 2019 6,967,208 the 208 patent november 21, 2026 u. Generic apixaban inn entry, pharmaceutical patent and.
Conduct a randomized, openlabel, activecontrolled, safety and descriptive. Apixaban directly inhibits factor xa, thereby interfering with the conversion of prothrombin to thrombin and. There are three patents protecting this drug and one paragraph iv challenge. This cumulative supplement is one of a series of monthly updates to the. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888info fda 18884636332 contact fda.
Bristolmyers squibb and pfizer announced today that it had received a a complete. The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug products approved on the basis of. A new drug application nda for the approval of apixaban was submitted to the fda by bristolmyers squibb and pfizer jointly after conclusion of the aristotle clinical trial in 2011. In addition, rivaroxaban and apixaban are approved for the prevention of venous thromboembolism vte in patients undergoing knee or hip replacement surgery. Apixaban is an anticoagulant blood thinner that reduces blood clotting and reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation apixaban is available under the. The eliquis clinical trial program is the largest completed clinical development program designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation. This drug is slightly less popular than comparable drugs. Jan 02, 20 the eliquis clinical trial program is the largest completed clinical development program designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients. Generic apixaban inn entry, pharmaceutical patent and freedom. Clinical trial results are important because they can help doctors consider and choose the right treatment for you based on their efficacy and safety results. Fda link 20191126 required postapproval safety study. Silver spring, md the us food and drug administration fda. The orange book appendices are available in pdf format.
Medication guide eliquis ell eh kwiss apixaban tablets. Apixaban is available under the following different brand names. Orange book contains therapeutic equivalence evaluations for approved multisource prescription drug products. Fda delays approval of noac reversal drug medpage today. Potential noac drug interactions dabigatran apixaban46 and rivaroxaban79 contraindicated note. Eliquis apixaban is the only one that can claim it reduces deaths in people with atrial fibrillation. Apixaban prevents blood from clotting normally, so it may take longer than usual for you to stop bleeding if you are cut or injured. Bristolmyers squibb and pfizer receive complete response letter from u. Transcript the orange book has long been a reliable resource for information about fdaapproved drugs. Fda approves eliquis apixaban to reduce the risk of.
At the end of 2011, the fda learned that an audit of a chinese site involved in a key clinical trial of a different anticlotting agent, apixaban, had turned up evidence of fraud. Fda approves apixaban eliquis for dvtpe treatment, recurrences. Dailymed eliquis apixaban tablet, film coated eliquis. Saw that the fda approved two generics for apixaban. Apixaban is metabolized mainly via cyp3a4 with minor contributions from cyp1a2, 2c8, 2c9, 2c19, and 2j2. Odemethylation and hydroxylation at the 3oxopiperidinyl moiety are the major sites of biotransformation. Fda approved indications1,2,3,4 dabigatran, rivaroxaban, and apixaban are indicated for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation af.
It looks like the earliest submission date for patent is listed as 12320, but that doesnt make sense bc it was already approved at that time. Apixaban has no direct effect on platelet aggregation, but by inhibiting factor xa, it indirectly decreases clot formation induced by thrombin. Representing petitioner amneal pharmaceuticals llc in ipr of u. There are currently no generic alternatives for eliquis. Dailymed eliquis apixaban tablet, film coated eliquis 30. Nci thesaurus ncit apixaban is a pyrazolopyridine that is 7oxo4,5,6,7tetrahydro1h. This material is provided for educational purposes only. Apixaban, better known as eliquis by its trade name, is a medication that is broadly classed as an blood thinner or anticoagulant. We make every effort to prevent errors and discrepancies in the approved drug products data files. Sep 27, 2012 the fda will decide the fate of apixaban eliquis by march 17, 20. Orange book cumulative supplement 03 march 2020 fda. Apixaban directly inhibits factor xa, thereby interfering with the conversion of prothrombin to thrombin and preventing formation of crosslinked fibrin clots.
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