Lupin got tentative approval for metformin ER tablets by USFDA

USFDA has given tentative approval to lupin for its AB rated generic equivalent of Andrx Labs LLC’s Fortamet 500mg and 1000 mg tablets, FORTAMET(R). Fortamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


As per Lupin's view, they are the first to file ANDA with paragraph IV certification, they will get the 180 days exclusivity on this product.  

Multiple 30 months stay: possible after MMA or not?

The Drug Price Competition and Patent Term Restoration Act of 1984, usually referred to as the Hatch-Waxman Act, was designed to promote generics but at the same time giving financial incentive for research and development to the innovator companies. It was changed so many times in so many manner which made very dramatic impact on the pharma industry in US.

Earlier multiple 30 month stay was allowed on filing ANDA with subsequent P IV certification due to new listing of patent in the orange book for the same product but after MMA, it is not allowed to get multiple 30 month stay.
Recently in a case FDA has allowed 30 month stay to the generics with explanation. To get full details please click here.

Natco files ANDA for lenalidomide capsules

Natco Pharma, a Hyderabad based pharma major, has filed an abbreviated new drug application (ANDA) with the US FDA for approval to market lenalidomide capsules in 5, 10, 15 and 25 mg strengths prior to the expiration of various US patents. Natco's lenalidomide capsules are the generic version of Celgene Corporation's Revlimid.


Acccording to company they are the first filer with providing paragraph IV certification and therefore will be awarded with 180 day exclusivity.

Torrent and Zydus got tentative approval for Duloxetine DR capsules

Gujarat based 2 pharma majors, Torrent pharma and Zydus healthcare received tentative approval from USFDA for Duloxetine delayed release oral capsules. They have filed ANDA against the Cymbalta the innovator product. Cymbalta is used for treating depression and generalized anxiety disorder. It is used for managing pain caused by fibromyalgia and diabetic peripheral neuropathy.

Paragraph IV patent certification list updated

For access to the generic players regarding the paragraph IV patent certification filed against which product and on what date, FDA is publishing the list at the FDA website. It get updated twice in a month and provides recent updated list. The list in PDF format contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency. At present list is available updated till 23 August 2010.


For more details and to dowanload complete list Click here

Market exclusivities for pharmaceuticals in USA

Freinds this topic is specially for the students and who are new to the field of patent and related things. Here i have explaiend some exclusivities available to pharmaceutical products in USA.

1) New Chemical Entity (NCE) (5 years)
It applies to any new drug that does not contain active ingredient (active moiety) earlier approved in as NDA by FDA. The term is 5 years and no any generic player can market generic product before expiry of NCE. However generic player can file the ANDA after the expiry of 4 years of NCE if they submit the paragraph IV certification. NCE can be extended by 6 months if pediatric exclusivity is granted.

2) First ANDA patent challenger (180 days)
After NDA, the very first ANDA alongwith Para IV certificate will get this 180-day exclusivity against subsequent ANDA filers. FDA will not approve another ANDA during 180 days exclusivity of the first ANDA holder.

3) New Clinical Investigations (3 years)
It applies to the new indication of known compound. Sponsor must submit the clinical trial data for the new indication. Generic player will not get the approval till the expiry of the exclusivity. However generic player can carve out the new indication and can go ahead with the known previous indication.

4) Orphan Drug (7 years)
It applies to the first NDA or BLA approved for a “rare” disease or condition. The definition “rare” disease is defined by any disease that affects less than 200,000 people in US, or affects more than 200,000 people in US but there is no “reasonable” expectation that development costs for drug will be recovered from US sales. Till the expiry of this exclusivity no any generic player can get the approval form the FDA for the same disease or condition.

5) Pediatric Exclusivity(6 months)
It applies to all the patents listed in the orange book as well as all other regulatory exclusivities. For this exclusivity, sponsor must provide the data of the pediatric clinical trials as requested by the FDA. Two separate 6 months pediatric extension can be possible.

6) Animal product exclusivity (5 years)
Veterinary drugs can also receive market exclusivity under the Generic Animal Drug and Patent Term Restoration Act (“GADPTRA”). Exclusivity is for either 3 or 5 years, during which time no other generic copy may be approved (in the case of 3-year exclusivity) or no other generic application may be submitted (in the case of 5-year exclusivity).

Impax Lab Vs Schering-Vytorin patent challenge

An abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic version of Vytorin has been filed by Impax with the US Food and Drug Administration (FDA).

Schering and MSP Singapore have filed suit for patent infringement against Impax in the US District Court for the District of New Jersey, on 19 August 2010.

Vytorin (ezetimibe and simvastatin) is indicated as adjunctive therapy to diet to reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia, as well as toreduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipidlowering treatments.

Impax's generic division, Global Pharmaceuticals, is expected to launch the products after final ANDA approval.