Points clés
- 1'Same salt' means the active pharmaceutical ingredient — the molecule producing the therapeutic effect — plus its salt form and strength.
- 2Approved generics must match the brand on ingredient, strength, form, route and absorption; only non-therapeutic parts may differ.
- 3Inactive ingredients can occasionally matter for allergies (lactose, dyes), even though they are pharmacologically inert.
- 4For US-approved products, the FDA Orange Book 'A' rating is the public, searchable answer on substitutability.
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1What 'salt' means in a medicine context
In pharmacy, the 'salt' is the active pharmaceutical ingredient — the molecule that produces the therapeutic effect. Atorvastatin calcium, metformin hydrochloride and amlodipine besylate are all salt forms of an active drug.
The salt form affects solubility and stability, which is why the full name matters. Two products described as 'the same' should match on the complete salt name and the strength, not just the shortened brand-facing name.
2What must be identical, and what may differ
Regulators require a strict match on the therapeutically relevant characteristics, while permitting variation in the parts that do not determine clinical effect.
| Characteristic | Must match the brand? |
|---|---|
| Active ingredient | Yes |
| Strength | Yes |
| Dosage form (tablet, injection…) | Yes |
| Route of administration | Yes |
| Rate and extent of absorption (bioequivalence) | Yes, within defined limits |
| Inactive ingredients (fillers, dyes, coatings) | No |
| Tablet shape, colour and markings | No |
| Brand name and packaging | No |
| Manufacturer | No |
3When is a generic genuinely interchangeable?
The FDA publishes therapeutic equivalence ratings in the Orange Book. Products rated 'A' are considered therapeutically equivalent and substitutable; those rated 'B' are not. This is a public, searchable resource, and it is the most authoritative single answer for US-approved products.
For most common chronic medicines — statins, ACE inhibitors, ARBs, metformin, PPIs, most antibiotics — substitution is routine and uncontroversial.
The exceptions are consistent worldwide: biologics and biosimilars follow a separate comparability pathway, modified-release formulations differ in release mechanism, and narrow-therapeutic-index drugs need monitoring after any change.
4Why the price differs so much if the molecule is the same
The brand price recovers discovery cost, failed candidates, trials, marketing and profit during a period of patent exclusivity when no competitor may sell the molecule. The generic price reflects manufacturing, quality control and distribution in a market where many companies compete on the identical product.
That is the entire explanation. It is a difference in commercial structure and patent status, not a difference in chemistry.
Ce que montre le jeu de données Jivan
- 59×
- écart moyen de prix
- 84%
- des ancres dépassent 10×
- 344×
- plus grand écart documenté
Across our full referenced dataset, 476 referenced molecules average a 59× price gap, 84% of them are at least 10× cheaper in India, and the widest documented comparison is Colchicine at 344×. Across the full referenced dataset the gap is systematic rather than anecdotal: 84% of anchored molecules are at least 10× cheaper, with a 59× average ratio — a market-structure effect repeated across all 26 therapy areas.
Calculé en direct à partir de 476 anchors
Questions fréquentes
Trade dress — shape, colour and markings — is usually protected by trademark, so generics must look different. Appearance has no bearing on the active ingredient or its effect.
For US-approved products, search the FDA Orange Book for the therapeutic equivalence code. An 'A' rating indicates the product is considered therapeutically equivalent to the reference listed drug.
Yes, but both active ingredients and both strengths must match, and bioequivalence must be demonstrated for the combination as supplied.
Sources et lectures complémentaires
Chaque fait ci-dessus est traçable vers une source primaire publique. Nous citons les régulateurs et les organismes de santé publique, pas les vendeurs commerciaux.
- 1Generic Drug FactsU.S. Food & Drug Administration
- 2Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)U.S. Food & Drug Administration
- 3Generic and Hybrid MedicinesEuropean Medicines Agency
- 4RxNorm Drug VocabularyU.S. National Library of Medicine
Comment cet article a été rédigé
Rédigé et recherché
Health Economics Editor, Jivan Editorial TeamRelu éditorialement
Editorial Review Board — Jivan
Regulatory mechanisms verified against primary sources.
Avertissement médical important
Consultez toujours un médecin avant de changer de médicament, de dose ou de marque. Jivan fournit des informations éducatives et tarifaires et ne remplace ni un diagnostic ni les soins d'urgence.