Drug Patents and Generic Pharmaceutical Drugs

Last Updated at: Feb 02, 2021
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Drug Patents
In January, 2021, Dr Reddy’s Laboratories said it has launched Febuxostat tablets, used to treat gout due to high uric acid levels, in the US market. The company has launched the product, which is a generic version of Teijin Ltd Uloric tablets, after getting approval from the US Food and Drug Administration (USFDA). The company said this in a regulatory filing.

 

To provide low-cost medicine and benefit the public, the Indian Drug Patent system encourages the production of two classes of drugs – costly and low-cost medicines. Further, here’s a look at drug patents and generic pharma drugs and their relationship.

  1. What is a generic pharma equivalent drug?

  2. What are the names of generic medicines in India?

  3. Can different generic pharmaceutical drugs work differently?

  4. What country produces the most generic pharma drugs?

  5. Is aspirin a generic pharma name?

  6. Why are generic medicines in India bad?

What is a generic pharma equivalent drug?

A generic equivalent drug is one that works the same way as a brand-name drug. In essence, it resembles the original pharmaceutical drug in dosage, usage, strength, quality, administration technique, and performance. Additionally, all these similarities help the generic drug to work the same way the original did, as it is biologically equivalent to it. Further, generic medicine should also perform the same clinical work. Further, they have to provide the same benefits as brand-name pharmaceutical. 

What are the names of generic medicines in India?

Now we know about generic pharmaceuticals, let us look at some typical generic pharmaceutical drugs list in India.

Sl No Generic Drug Name  Used For Treatment Of
1 Paracetamol Fever
2 Cefixime Bacterial Infection
3 Amoxicillin Bacterial infection
4 Ofloxacin Diarrhoea
5 Pefloxacin Anti-biotic

 

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Can different generic pharmaceutical drugs work differently?

New drugs have to undergo rigorous testing and approval procedure before they receive drug patents in India. Moreover, once they get such a license, they become the only company allowed to manufacture, market, and sell that drug. However, once the patent expires, other companies can sell generic pharmaceutical versions of the same drug, via a more straightforward approval process. Further, the generic drug contains the same amount of active ingredients but might have different fillers. Therefore, while they might have the same end effect, the way they work and get absorbed may be different.

While for some medicines that do not make a difference, for others, it might lead to a significant change. For instance, pharmaceutical drugs that help prevent seizures must be absorbed into the blood in the right amounts to be active. Therefore, people who do well on one generic drug might not do as well on another. The same holds when people shift from a brand-name drug to a generic pharma. When different companies manufacture the same generic pharmaceutical, they might use various fillers, leading to a difference in absorption and potency. Therefore, this can lead to minor variations in the rate of absorption, side effects caused, and other such issues. 

What country produces the most generic pharma drugs?

Not surprisingly, due to a large middle-class population, India dominates the generic pharma market, producing large amounts of generic pharmaceuticals. Additionally, India exported generic drugs worth $17.3 billion between 2017 and 2018. Similarly, this roughly corresponds to 20% of the world’s generic pharmaceutical drugs market. Further, the major importers of generic medicines from India are Brazil, the US, Russia, South Africa, and the UK. Therefore, the extensive pharmaceutical drugs list manufactured in India as generics has led to its reputation as the “World’s pharmacy.”

Is aspirin a generic pharma name?

Aspirin comprises acetylsalicylic acid and is a pharmaceutical that works as a non-steroidal anti-inflammatory drug. Similarly, commonly used to treat moderate pain, fever, rheumatoid arthritis. Further, blood clots, it is a drug consumed heavily around the world. Also, individuals who suffer from kidney disorders, liver damage. Additionally, haemophilia should always consult a physician before taking this drug.

Researchers at the Bayer company were the first to mass-produce the drug in 1897. Moreover, they named it Aspirin and marketed it around the world as a replacement for other salicylate medicines. In time, the drug became extremely popular, leading to tight competition around the world. While the name Aspirin formerly served as Bayer’s brand name, it has become a generic name for the drug. Therefore, some of the brand names of Aspirin in India are Clopitab, Venator, Clospir, Mazoral, Opri, Asogrel-A, and Solosprin.

Why are generic medicines in India bad?

For example, Indian generic medicines and the generic pharma market in India have several quality and safety concerns. For instance, in 2013, Ranbaxy pleaded guilty to several charges related to the sale of adulterated drugs. Further, the disgraced pharma company had to pay over $500 million as fines for the same as they were caught manipulating testing results to fast track manufacturing. Additionally, this case also led many to believe that India’s generic pharma market produced low-quality and ineffective generic pharmaceuticals.

While these companies produce better drugs for export to foreign nations as they have stringent policies, they sell substandard drugs in India. Therefore, as per a study done by the Journal of Drug Delivery and Therapeutics, over 47.8% of people preferred branded drugs. Similarly, it is as they felt they were more effective than generic drugs. Therefore, the quality, efficiency, and standards of generic drugs in India is a growing concern for the public and the government.