That Fusilev and generic Leucovorin are interchangeable is debatable. With generics you have the inert form competing with the active form. Generic Fusilev would pose a greater threat to sales.
There is no generic on the market, Sandoz filed a generic submission.
SPPI is awarded 7 years exclusivity, period, because they ran the trials for a patient population who needs the treatment, Orphan Drug. Look it up.
You don't even need a patent to get 7 years exclusivity, you can take a known compound and find a use for it in a unique patient population and still get 7 years. FDA wants to encourage drug development and award companies who fund trials for unmet needs, thus Orphan Drug designation is sought after by biotech firms.
When Fusilev was approved in 2008, generics filed ANDAs for generic drug approval. Now as we approach 2015, then end of Orphan Status, the patent for Fusilev matters for the first approved indication.... Generics always file ANDAs soon after approval
"Levoleucovorin provides physicians and patients with an important treatment alternative to leucovorin," said Richard A. Bender, M.D., F.A.C.P., Chief Medical Officer of Spectrum Pharmaceuticals. "With this drug, patients undergoing cytotoxic chemotherapy are spared the administration of the pharmacologically inactive dextro-isomer. Preclinical studies have shown that the dextro-isomer may compete with the active levo-isomer for transport into cells."
The Company plans to file for a supplemental New Drug Application with the FDA for use in colorectal cancer in 5-fluorouracil containing regimens and an NDA amendment for an oral tablet formulation by mid-year 2008.
No Good Precedent Goes Overlooked: FDA is Asked to Reset FUSILEV Approval and Exclusivity Dates Because of Proprietary Name Review
"Spectrum requests that FDA update the Orange Book to state that the company’s FUSILEV (levoleucovorin) for Injection drug product approved under NDA 020140 was approved 129 days after the date currently listed in the publication – on July 14, 2008 rather than March 7, 2008 – and that the period of 7-year orphan drug exclusivity expires 129 days later than currently listed – on July 14, 2015 instead of March 7, 2015."
Generics ALWAYS file for ANDAs for every new drug approval. They want to be the first to produce generics.
Use your head, Fusilev has exclusivity through 2018 for the colorectal indication because it is an Orphan Drug. Patents are irrelevant if drug is Orphan.
These type of chart and tech upgrades are meaningless, don't use them, there is only one thing that matters now, clarity over Fusilev protection. That is the only thing that matters now.
Question to Spectrum, How will your Orphan Drug exclusivity status be protected for Fusilev's use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer through 2018?
What steps are taken to ensure that any generic Fusilev that might come to market for the osteosarcoma indication won't be used for the colorectal indication? All assuming that you have zero patent coverage.
The issue here, Fusilev was also given Orphan Drug status in 2008, OD lasts 7 years, so March 2015 for the osteosarcoma indication runs out soon. If they have no patent protection, generics can come to market with Fusilev for that indication. Orphan Drug is there to aid smaller companies, to encourage drug development whether or not you have a patent. It trumps patents, like a safety net.
If there is a cap on generic supply through 2018, then SPPI still gets a decent amount of revenue for a few more years, enough to further their pipeline without significant dilution.
Market Edge and chart techs are irrelevant when there is a binary bomb like the potential loss of patent coverage. Since I doubt generics will be mass produced any time soon, it is likely overblown right now, but this type of event creates fear and uncertainty that will contribute to weakness.
This is the most important question. Orphan Drug status was given to Fusilev in 2008 for their first approval indication. The smaller patient population, osteosarcoma. That runs out in March 2015, so if there is no patent, generic Fusilev can come for that indication.
But, Spectrum has Orphan status for the larger colorectal population that is protected from generics through 2018, that population should not be given generic Fusilev, so how does the FDA control that?
The most important factor is the issue of Orphan Drug exclusivity and if generics can use the earlier 2008 approval of Fusilev to get around the other Orphan Drug exclusivity for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer, where they get most revenue for Fusilev.
Fusilev was approved in 2008 for much smaller indication (as a rescue after high-dose methotrexate therapy in osteosarcoma), and the orphan drug exclusivity associated with that indication expires in March 2015.
It seems to me that generics can't supply the market with generic Fusilev for palliative treatment of colorectal cancer until 2018, per the Orphan status.
No, a patent troll secures or acquires a patent (not something they invented and use) and tries to squeeze money from another company. Netlist invented their tech and patented it. The manufacture and sell their tech... They license their patents, as do many, many other companies.
Completely wrong. TDox is specific only to the tumor where heat is applied. Gen-1 isn't TDox. Ovarian cancer is not HCC.