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Fosamax Patent History and Generic Alendronate Timeline

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At a glance

  • Brand / Fosamax (Organon); Fosamax Plus D [1]
  • Active ingredient / alendronate sodium, an oral bisphosphonate [2]
  • Original FDA approval / 29 September 1995, NDA 020560 [1]
  • Combination product / Fosamax Plus D, NDA 021762, approved 7 April 2005 [1]
  • Generic status / FDA-approved tablets and oral solution under many ANDAs [1]
  • Brand forms no longer marketed / 5 mg, 10 mg, 35 mg and 40 mg tablets, plus oral solution [2]
  • Boxed warning / none on the Fosamax label [1]
  • Label date / 12 March 2026 [2]

Approval and the fracture evidence

Fosamax was approved on 29 September 1995 under NDA 020560 [1]. A 1996 report of the Fracture Intervention Trial described fracture outcomes in 2,027 postmenopausal women with at least one vertebral fracture: after 36 months, new morphometric vertebral fractures occurred in 8.0% of the alendronate group versus 15.0% on placebo (relative risk 0.53, 95% CI 0.41 to 0.68), with a relative hazard of 0.49 (0.23 to 0.99) for hip fracture and 0.52 (0.31 to 0.87) for wrist fracture [4].

Are generic alendronate products available?

Yes. Generic alendronate tablets and oral solution are FDA-approved under many abbreviated new drug applications [1].

Under the Hatch-Waxman Amendments, patents a brand sponsor submits to the FDA are listed in the Orange Book, and a generic applicant can seek approval before those patents expire by filing a Paragraph IV certification that the patent is invalid, unenforceable or will not be infringed. The first substantially complete applicant with such a certification is generally eligible for 180 days of exclusivity, and if the brand or patent holder sues within 45 days, approval is generally postponed for 30 months [3].

Which strengths carry the brand name today?

The current label says Fosamax is no longer marketed in the 5 mg, 10 mg, 35 mg and 40 mg strengths, and that Fosamax oral solution is no longer marketed, although generic versions of those may be available [2]. The label still describes 70 mg once weekly or 10 mg daily for treating osteoporosis in postmenopausal women and in men, and 35 mg once weekly or 5 mg daily for prevention in postmenopausal women [2].

Is once-weekly dosing as effective as daily dosing?

In a one-year, double-blind trial, mean lumbar spine bone mineral density rose 5.1% with alendronate 70 mg once weekly (n=519) and 5.4% with 10 mg daily (n=370), and the 70 mg once-weekly regimen met the predefined equivalence criteria against daily therapy [5]. In a claims analysis of 2,741 women newly prescribed a weekly alendronate or a daily bisphosphonate (alendronate or risedronate), 44.2% of weekly users were still on treatment at 12 months versus 31.7% of daily users [6].

Frequently asked questions

When was Fosamax approved?
Fosamax was approved on 29 September 1995 under NDA 020560. Fosamax Plus D, alendronate with cholecalciferol, was approved under NDA 021762 on 7 April 2005 [1].
Is generic alendronate available in the US?
Yes. Generic alendronate tablets and oral solution are FDA-approved under many abbreviated new drug applications [1].
Can I still get brand-name Fosamax?
The label says Fosamax is no longer marketed in the 5 mg, 10 mg, 35 mg and 40 mg strengths or as an oral solution, though generic versions of those may be available [2].
How long is alendronate taken?
The label says the optimal duration of use has not been determined, that efficacy and safety data cover four years, and that patients at low risk of fracture should be considered for discontinuation after 3 to 5 years [2].

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. U.S. National Library of Medicine, DailyMed. Fosamax (alendronate sodium) tablets prescribing information. Fosamax (alendronate sodium) tablets label
  3. Patent Certifications and Suitability Petitions | FDA. Patent Certifications and Suitability Petitions | FDA
  4. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996;348(9041):1535-41. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group
  5. Schnitzer T, Bone HG, Crepaldi G, Adami S, McClung M, Kiel D, et al. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano). 2000;12(1):1-12. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group
  6. Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005;21(9):1453-60. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis
Evidence overview for Fosamax Patent History and Generic Alendronate Timeline