Dear Colleagues! This is Asrar Qureshi’s Blog Post #727 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to firstname.lastname@example.org for publishing your contributions here.
New products are the lifeline of pharmaceutical companies all over the world. Most new products are developed in the US, or by the US-based companies who may do research elsewhere. Japan is also credited with new molecules introduction. Europe has gone far behind in this process. European companies have either shifted their base to the US or are collaborating with the companies there to come up with new research products. Rest of the world is contented with the generics business. Pakistan is the same. The local corporates keep looking at the new molecules introduced/ approved by the USFDA, EMA – European Medicine Agency, or Pharmaceutical and Medical Devices Agency – PMDA.
Local corporates in Pakistan have done great work in bringing generic versions of research products fast. There are patent restrictions, otherwise it would be even faster. The launch of products still in patent is a legal and commercial issue, but it is also taken as public benefit matter. The companies take the plea that they are doing it so that the public can get new drugs at affordable prices. We may discuss it on some other occasion.
When USFDA approves a generic, it means that the patent has expired or is about to expire. Let us look at some, not all, approvals of 2022 which may be more relevant to Pakistan market.
- Pencyclovir cream 1% – antiviral cream – treatment for cold sores. Cold sores are a big problem for patients who remain bedridden for long periods due to illness.
- Vancomycin HCl for Oral Solution 25mg and 50mg (base) per mL – for bacterial infections. It is interesting because vancomycin has so far been available only as injections.
- Riociguat Tablets 0.5mg. 1mg, 1.5mg, 2.0mg, & 2.5mg – for the treatment of pulmonary hypertension. Should be interesting for pharma companies active in cardiovascular segment.
- Cariprazine HCl capsules 1.5mg, 3.0mg, 4.5mg, & 6.0mg (base) – treatment for schizophrenia. Companies active in neuropsychiatry segment were already following this molecule.
- Nebivolol HCl and Valsartan 5mg/80mg tablets – Nebivolol is catching up in Pakistan while valsartan combinations are already reigning supreme.
- Gefitinib 250mg tablets – treatment for Non-Small Cell Lung Cancer. NIBs are among the fastest growing treatment for various types of cancer. Their biggest advantage is their oral administration.
- Empagliflozin tablets – for type 2 Diabetes has already been marketed in Pakistan by several companies. Available alone and in combination with metformin. Combination with Linagliptin and Saxagliptin is also in progress.
- Brexpiprazole 0.25mg, 0.5mg, 1mg, 2mg, 3mg, & 4mg tablets – treatment for depression. The earlier product of this family, aripiprazole, became a blockbuster internationally but did not sell well in Pakistan. Let us see if someone will be interested in this molecule for launch in Pakistan.
- Azilsartan Kamedoxomil 40mg & 80mg tablets – treatment for high blood pressure. Many members of this family, Losartan, Valsartan, Candesartan, Irbesartan etc. are already available on the market with varying degrees of acceptance.
- Brivaracetam 10mg, 25mg, 50mg, 75mg, & 100mg tablets – treatment for epilepsy. The first drug of this family, piracetam, was launched decades ago; levetiracetam is now catching up. Brivaracetam is already on the radar of companies active in neuropsychiatry segment.
- Minocycline HCl 100mg base/vial Injection – treatment for bacterial infections. This is also interesting because minocycline has always been available as oral drug.
- Cabazitaxel 60mg/1.5ml Injection – treatment for Prostate Cancer. Generic version was eagerly awaited.
- Abiraterone Acetate 125mg tablets – treatment for Prostate Cancer. Smuggled generics have been available from India.
- Lacosamide 200mg/20ml Injection and 10mg/ml Oral Solution – treatment for seizures. The drug is already available on the Pakistan market.
- Pemetrexed disodium 100mg & 500mg base/vial Injection Solution – treatment for Mesothelioma, Non-Small Cell Lung Cancer. Generic versions are already available.
- Brimonidine tartrate & Timolol maleate 0.2% & 0.5% ophthalmic solution – treatment for glaucoma. It is a good addition to the glaucoma drugs already on the market.
- Cyclosporine 0.05% ophthalmic solution – treatment for Dry Eye Disease. Dry Eye disease is very common in Pakistan and elsewhere. One reason offered for increase in the incidence is the increased screen time on mobile phones and computers. Common treatment is frequent use eye drops which keep the eyes moist. Cyclosporine is an immunosuppressant and may work better than the present formulations.
- Pirfenidone 267mg capsules – treatment for Idiopathic Lung Fibrosis. The drug had been selling on the market for several years. It was manufactured by Cipla India and was smuggled here without interruption. The drug has already been marketed by Highnoon in technical collaboration with Cipla.
Drugs like Methylphenidate for ADHD, Nalmefene for opioid overdose, and apomorphine for Parkinson’s disease are not granted registration by DRAP in their own wisdom. They also did not allow ED products; Sildenafil, Tadalafil, and Vardenafil, despite an established medical need. Needless to point out that all of these are selling through gray channel.
I would again emphasize that new products are needed to stay ahead of the competition in the marketplace. Many of the above products can be surely considered for introduction in Pakistan.
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