The composition of Drugs going off-patent in the upcoming years
As a follow up on the article 𝐖𝐡𝐢𝐜𝐡 𝐝𝐫𝐮𝐠𝐬 𝐰𝐢𝐥𝐥 𝐥𝐨𝐬𝐞 𝐩𝐚𝐭𝐞𝐧𝐭𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐜𝐨𝐦𝐢𝐧𝐠 𝐲𝐞𝐚𝐫𝐬? by Joanna Sadowska, PhD, EMBA in which includes over 30 products going off-patent from 2025 to 2037 we pulled together the dosage form and composition of these products. Please note that the composition may vary in different markets and the listing is as indication only. For the most accurate and up-to-date information, always refer to the official prescribing information or consult a healthcare professional.
For most of the excipients listed you will find further information on https://www.pharmaexcipients.com/shop/ and on the website in general. For some products we have interested direct links to the information.
(click the picture to enlarge)
Xarelto (Johnson & Johnson)
- Dosage Form: Film-coated tablets
- Composition (Excipients): Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, magnesium stearate, titanium dioxide (E171), macrogol 3350, iron oxide red (E172), and iron oxide yellow (E172).
- Source: Xarelto 2.5 mg Summary of Product Characteristics
Entresto (Novartis)
- Dosage Form: Film-coated tablets
- Composition (Excipients): Microcrystalline cellulose, low-substituted hydroxypropyl cellulose, crospovidone, magnesium stearate, talc, silica colloidal anhydrous, hypromellose, titanium dioxide (E171), macrogol 4000, talc, iron oxide red (E172), and iron oxide yellow (E172).
- Source: Entresto Summary of Product Characteristics
Farxiga (AstraZeneca)
- Dosage Form: Film-coated tablets
- Composition (Excipients): Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and iron oxide yellow (E172).
- Source: Farxiga Prescribing Information
Prolia (Amgen)
- Dosage Form: Solution for injection (pre-filled syringe or vial)
- Composition (Excipients): Acetate, polysorbate 20, sorbitol, sodium hydroxide, and water for injection.
- Source: Prolia Summary of Product Characteristics
Eliquis (Bristol Myers Squibb & Pfizer)
- Dosage Form: Film-coated tablets
- Composition (Excipients): Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, and iron oxide yellow (E172).
- Source: Eliquis Summary of Product Characteristics
Trulicity (Eli Lilly)
- Dosage Form: Solution for injection (pre-filled pen)
- Composition (Excipients): Mannitol, citric acid monohydrate, trisodium citrate dihydrate, and water for injection.
- Source: Trulicity Prescribing Information
Ocrevus (Roche)
- Dosage Form: Solution for infusion
- Composition (Excipients): Sodium acetate, trehalose dihydrate, polysorbate 20, and water for injection.
- Source: Ocrevus Summary of Product Characteristics
Xtandi (Pfizer & Astellas)
- Dosage Form: Soft gelatin capsules
- Composition (Excipients): Caprylocaproyl macrogolglycerides, butylhydroxyanisole, gelatin, glycerol, sorbitol, and titanium dioxide (E171).
- Source: Xtandi Summary of Product Characteristics
Imbruvica (AbbVie & Johnson & Johnson)
- Dosage Form: Hard capsules and tablets
- Composition (Excipients): Capsules: Croscarmellose sodium, magnesium stearate, titanium dioxide (E171), gelatin. Tablets: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and a film-coating containing polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, and talc.
- Source: Imbruvica Summary of Product Characteristics
Keytruda (Merck)
- Dosage Form: Lyophilized powder for solution for infusion or solution for infusion (ready-to-use)
- Composition (Excipients): Histidine, sucrose, polysorbate 80, and water for injection.
- Source: Keytruda Summary of Product Characteristics
Opdivo (Bristol Myers Squibb)
- Dosage Form: Solution for infusion
- Composition (Excipients): Trisodium citrate dihydrate, citric acid monohydrate, sucrose, polysorbate 80, and water for injection.
- Source: Opdivo Summary of Product Characteristics
Gardasil 9 (Merck)
- Dosage Form: Suspension for injection (pre-filled syringe or vial)
- Composition (Excipients): Sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.
- Source: Gardasil 9 Summary of Product Characteristics
Darzalex (Johnson & Johnson)
- Dosage Form: Solution for infusion
- Composition (Excipients): Sodium acetate trihydrate, acetic acid glacial, mannitol, polysorbate 80, and water for injection.
- Source: Darzalex Summary of Product Characteristics
Cosentyx (Novartis)
- Dosage Form: Solution for injection (pre-filled syringe or pen)
- Composition (Excipients): Sucrose, L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and water for injection.
- Source: Cosentyx Summary of Product Characteristics
Enbrel (Amgen)
- Dosage Form: Solution for injection (pre-filled syringe, vial, or pen)
- Composition (Excipients): Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, and water for injection.
- Source: Enbrel Summary of Product Characteristics
Dupixent (Sanofi & Regeneron)
- Dosage Form: Solution for injection (pre-filled syringe or pen)
- Composition (Excipients): L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, glacial acetic acid, sucrose, and water for injection.
- Source: Dupixent Summary of Product Characteristics
Ozempic (Novo Nordisk)
- Dosage Form: Solution for injection (pre-filled pen)
- Composition (Excipients): Disodium phosphate dihydrate, propylene glycol, phenol, and water for injection.
- Source: Ozempic Summary of Product Characteristics
Tagrisso (AstraZeneca)
- Dosage Form: Film-coated tablets
- Composition (Excipients): Mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium stearyl fumarate, and a film coating containing hypromellose, titanium dioxide (E171), and polyethylene glycol 400.
- Source: Tagrisso Summary of Product Characteristics
Entyvio (Takeda)
- Dosage Form: Lyophilized powder for solution for infusion
- Composition (Excipients): L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.
- Source: Entyvio Summary of Product Characteristics
Biktarvy (Gilead)
- Dosage Form: Film-coated tablets
- Composition (Excipients): Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and a film coating containing polyvinyl alcohol, titanium dioxide (E171), macrogol/polyethylene glycol, talc, and iron oxide red (E172).
- Source: Biktarvy Summary of Product Characteristics
Skyrizi (AbbVie)
- Dosage Form: Solution for injection (pre-filled syringe or pen)
- Composition (Excipients): Sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 20, and water for injection.
- Source: Skyrizi Summary of Product Characteristics
Prevnar 20 (Pfizer)
- Dosage Form: Suspension for injection (pre-filled syringe)
- Composition (Excipients): Aluminum phosphate, sodium chloride, and water for injection.
- Source: Prevnar 20 Prescribing Information
Rinvoq (AbbVie)
- Dosage Form: Extended-release tablets
- Composition (Excipients): Lactose monohydrate, microcrystalline cellulose, hypromellose acetate succinate, magnesium stearate, and a film coating containing polyvinyl alcohol, titanium dioxide (E171), macrogol/polyethylene glycol, talc, and iron oxide red (E172).
- Source: Rinvoq Summary of Product Characteristics
Mounjaro (Eli Lilly)
- Dosage Form: Solution for injection (pre-filled pen)
- Composition (Excipients): Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, and water for injection.
- Source: Mounjaro Prescribing Information
Trikafta (Vertex)
- Dosage Form: Film-coated tablets
- Composition (Excipients): Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), polyethylene glycol, and iron oxide yellow (E172).
- Source: Trikafta Summary of Product Characteristics
Please note that excipient compositions can vary by manufacturer and region. For the most accurate and up-to-date information, always refer to the official prescribing information or consult a healthcare professional.
Read the original article here
Source: Philippe Tschopp, LinkedIn The composition of Drugs going off-patent in the upcoming years, https://www.linkedin.com/pulse/composition-drugs-going-off-patent-upcoming-years-philippe-tschopp-uqv1e/
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