Estimating generic availability for drugs used in osteoporosis

[chantell.reagan]

We've updated the estimated generic availability dates for osteoporosis drugs, as outlined below*



Actonel (5, 30 and 35mg formulations)

First generic approval/launch forecast:

o Expected in 6/2014

Background, details, and sources:

o All currently listed patents expire by 12/10/2018 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification was filed as of 4/04. In 1/2008, District Court confirmed the validity of the '122 patent, which is set to expire in 6/2014 (for the 5, 30 and 35mg formulations); which was upheld on appeal. (Sources:FDA paragraph IV list; Teva press release 2/08; FDA news 3/09; FDA’s Orange Book; Orange Book Blog 3/08; Teva press release, 5/09)
o FDA has approved Teva’s generic in 10/2007. However, Teva did not launch the generic risedronate due to patent litigation; Teva expects to market its generic no later than 6/10/2014, when the ‘122 patent expires. (Sources: Teva press release 5/09; Drugs@FDA)

Actonel (150mg formulation)

First generic approval/launch forecast:

o Expected in 11/2023 or earlier

Background, details, and sources:

o All currently listed patents expire by 11/6/2023 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification was filed as of 8/08. P&G/W&C filed suits against Sun, Apotex, Mylan starting 1/2009 defending the '938 patent which is expires in 11/2023; litigation appears to be ongoing. (Sources:FDA paragraph IV list; FDA news 3/09; FDA’s Orange Book; Orange Book Blog 3/08; P&G court complaint 1/09)
o As of 5/10, the FDA has not approved a tentative or final version of the 150 formulation. (Sources: Drugs@FDA)

Boniva 150mg tablet

First generic approval/launch forecast:

o Expected in 5/2023 or earlier

Background, details, and sources:

o All currently listed patents expire by 5/6/2023 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification has been filed as of 5/07. Beginning in 2007, Roche filed several patent infringement lawsuits against Apotex, Cobalt, Dr. Reddy’s, Gate, Genpharm, Mutual, Orchid and Teva. In question are the '814, '196, ‘957 and '938 patents, expiring by 5/6/2023. In 2/09, Roche dropped the ‘196 patent from litigation for all 8 defendants. It appears that litigation pertaining to the other 3 patents is still ongoing. (sources: Sample court complaint 9/2007; Patent Docs 2/09; GSK annual report, 2009 FDA paragraph IV list)
o As of 5/10, the FDA has not approved a tentative or final version of ibandronate tablet. (Sources: Drugs@FDA)

Boniva injection 1mg/ml

First generic approval/launch forecast:

o Expected in 9/2014 or earlier

Background, details, and sources:

o All currently listed patents expire by 9/2/2014 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification has been filed as of 8/07. No public record pertaining to the related litigation could be located. (sources: FDA paragraph IV list)
o As of 5/10, the FDA has not approved a tentative or final version of ibandronate injection (Sources: Drugs@FDA)

Evista

First generic approval/launch forecast:

o Expected in 3/2014 or earlier

Background, details, and sources:

o All currently listed patents expire by 3/10/2017 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification was filed. Beginning in 2006, Lilly filed a patent infringement lawsuit against Teva defending multiple patents which are set to expire by 3/2017. The originally set 30-month stay period was extended by courts to 3/9/09, at which point a temporary restraining order was issued prohibiting Teva from launching the generic until outstanding patent litigation is resolved. In 9/2009, the court validated four patents which are set to expire by 3/2014 and invalidated two patents which are set to expire by 3/2017; both companies are appealing. Additionally, InvaGen Pharmaceuticals submitted an ANDA in 2008 seeking approval to market a generic, as well as Watson in 5/10. Lilly has since filed suit against InvaGen. (sources: Lilly 10-Q SEC filing 4/30/10; Watson press release 5/10; Orange Book Blog 2/07; Patent Docs 3/09; Lilly press release 3/09; FDA news article 4/09; Lilly Annual Report, 2009; Teva press release, 9/2009 FDA’s Orange Book)
o FDA has issued a tentative approval for Teva’s generic product as of 4/08 (sources: Drugs@FDA, FDA’s list of paragraph IV patent certifications)

Reclast

First generic approval/launch forecast:

o Expected in 3/2013 or earlier

Background, details, and sources:

o All currently listed patents expire by 3/2/2013 (Sources: FDA's Orange Book)
o At least one ANDA with paragraph IV certification has been filed as of 8/08. In 12/08, Novartis filed a patent infringement suit against Teva, regarding the ‘130 patent; litigation is ongoing with a possibility of at-risk launch at the end of 2010. (Sources: Patent Docs 12/08; Novartis annual report 2009; FDA paragraph IV list)
o As of 5/10, the FDA has not approved a tentative or final version of zoledronic acid 5mg/100ml (Sources: Drugs@FDA)

Zometa

First generic approval/launch forecast:

o Expected in 3/2013 or earlier

Background, details, and sources:

o All currently listed patents expire by 3/2/2013 (Sources: FDA’s Orange Book)
o At least one ANDA with paragraph IV certification has been filed as of 6/08. In 7/09, Novartis filed a patent infringement lawsuit against Teva, regarding the ‘130 patent; litigation is ongoing with a possibility of at-risk launch around 5/2011 (Sources: Patent Docs 8/08; Novartis annual report 2009; FDA paragraph IV list)
o Beginning in 4/09, the FDA has tentatively approved generics by Apotex, as well as others including Bedford, Hospira, Pharmaforce and Sun (Sources: Drugs@FDA)

*Of note: Forteo falls under the "biologic" category and will be subject to the new biosimilar pathway as the healthcare reform details are worked out.