Generics
Texan judge invalidates Restasis patents
On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine ophthalmic emulsion).
Perceptions of generic drugs in Latin America: a Guatemalan case study
A recent assessment of generic drug use in Guatemala [1] revealed a widespread lack of trust in generics, due to a combination of poor quality, powerful advertising campaigns and limited state regulation.
Lupin launches generic pain-relief med in US
India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 10 October 2017 that it had launched a generic version of Allergan’s Norco (hydrocodone/acetaminophen) pain medication.
FDA trying to reduce hurdles for complex generics
Although US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb admits that ‘FDA doesn’t control drug pricing’, he points to the fact that FDA ‘policies do affect competition in the market’. With this in mind he announced on 2 October 2017 ‘a major new set of policies’ aimed at making it easier to bring generic competition to complex drugs.
Challenges in the rediscovery of old generics
Finding new treatment options by repurposing generics is a cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics there are multiple obstacles standing in the way [1].
FDA approves lidocaine ointment generic from Vitruvias Therapeutics
US-based generics maker Vitruvias Therapeutics (Vitruvias) announced on 29 September 2017 that it had received approval of a new drug application from the US Food and Drug Administration (FDA) for a new drug.
Repurposing thioguanine
Repurposing and re-registering old generics is a cost-effective and time-efficient way of finding new purposes for existing drugs. One such ‘old generic’ that has been repurposed and re-registered is thioguanine [1].
US tribal patent deal could prevent generics
A deal made between Allergan and a native American tribe could potentially protect the company from challenges on its dry eye drug Restasis (cyclosporine ophthalmic emulsion) and prevent competition from generics in the US.
Repurposing and re-registering old generics
Finding new indications for existing drugs is better known as drug rediscovery, drug repurposing or drug repositioning. It is cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics, the lack of a formal regulatory pathway for such drugs and a lack of economic interest by pharmaceutical companies, makes it a challenging pursuit [1].
FDA forms working group to increase generics competition
US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb had announced the creation of a working group of senior staff focused on increasing generic drug competition.
