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      • Carbohydrates
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      • Microcrystalline Cellulose
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      • Mineral Stearates
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      • Disintegrant / Superdisintergrant
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    • Emulsifier – Glidant
      • Emulsifier
      • Excipient for Inhalation
      • Filler
      • Film former
      • Flavour / Flavor
      • Glidant
    • Lubricant – Preservative
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      • Nanotechnology
      • Orally Dissolving Technology Excipient
      • Pellet
      • Plasticizer
      • Preservative
    • Solubilizer – Viscocity Agent
      • Solubilizer
      • Speciality Excipient
      • Surfactants
      • Suspension Agent
      • Sustained Release Agent
      • Sweeteners
      • Taste Masking
      • Topical Excipient
      • Viscocity Agent
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    logo roquette
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    Pfanstiehl
    pharm-a-spheres
    pharm-a-spheres
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    PMC Isochem
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    Seppic
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    ShinEtsu
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    Sigachi
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    SPI Pharma
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      • Ashland
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Startseite » News » The composition of Drugs going off-patent in the upcoming years

The composition of Drugs going off-patent in the upcoming years

12. December 2024
The composition of Drugs going off-patent in the upcoming years

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)

Image by Joanna Sadowska
Image by Joanna Sadowska

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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      • Flavour / Flavor
      • Glidant
    • Lubricant – Preservative
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  • Sources
    • Handbook of Pharmaceutical Excipients – 9th Edition
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      • Budenheim
    • C-G
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      • Croda
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