Pro Tier Module
Drug Patent & Exclusivity Expiration Calculator
Hatch-Waxman patent, PTE, and exclusivity expiration dates - exact UTC calendar math, in-browser.
See it run - a worked example, 100% in this browser tab
The problem
Generic-strategy, patent, and IP teams must combine a drug's patent term, 35 USC 156 restoration, pediatric add, and NCE and orphan bars to find the earliest lawful generic entry - a tangle of statutory date math that is error-prone by hand.
The local-first solution
This plugin runs the exact UTC calendar arithmetic the statute prescribes on your confirmed dates entirely in your browser, returning the controlling latest-of bar and echoing every date it used, with nothing uploaded to anyone's cloud.
What it does
Base patent term: 20 years from filing or your entered nominal expiry
35 USC 156 PTE: half the testing phase plus all of approval, with the 5-year and 14-year caps
Pediatric exclusivity as a true +6-month add on patents and statutory bars
NCE exclusivity 5-year bar plus the 4-year earliest Paragraph IV submission date
Orphan-drug 7-year bar and the 180-day first-filer generic window
Latest-of controlling-date selection across all active bars
Honest scope
Exact here is all calendar date math, the 156 half-testing-plus-approval formula, both caps, the +6-month pediatric add, the NCE and orphan bars, and the latest-of selection; the IND, submission, approval, and patent dates and the NCE, orphan, and pediatric flags are dated inputs you confirm against the Orange Book and FDA letter. It does not determine PTE eligibility, the regulatory review period, listing, infringement, or validity; PTA, pre-1995 patents, the 30-month stay, and BPCIA biologics exclusivity are not modeled. Not legal advice.
Authorities cited
- 35 U.S.C. 156 - Extension of patent term (patent term restoration): the regulatory-review period and the restoration formula for a product subject to FDA premarket approval.
- 35 U.S.C. 156(g)(1)(B) - For a drug product, the regulatory review period = the testing phase (IND effective to NDA/BLA submission) plus the approval phase (submission to approval); only one-half of the testing phase counts toward restoration (35 USC 156(c)(2)).
- 35 U.S.C. 156(c)(3) - The 14-year cap: the period remaining in the term of a patent after the extension may not exceed fourteen years measured from the product's approval date.
- 35 U.S.C. 156(g)(6) - The 5-year cap: the period of extension may not exceed five years.
- 35 U.S.C. 154(a)(2) - 20-year patent term measured from the earliest U.S. non-provisional filing date (for patents filed on or after June 8, 1995).
- 37 CFR 1.775 - PTO calculation of the patent term extension period and the regulatory review period (the eligibility / RRP determination is a PTO/FDA function).
- FDCA 505A / 21 U.S.C. 355a - Pediatric exclusivity: six additional months attached to existing patent and exclusivity protections upon a qualifying pediatric study.
- FDCA 505(j)(5)(F)(ii) & 505(c)(3)(E)(ii) / 21 U.S.C. 355 - 5-year New Chemical Entity exclusivity from approval (no ANDA/505(b)(2) submission), reduced to 4 years for a Paragraph IV submission.
- FDCA 505(j)(5)(B)(iv) / 21 U.S.C. 355 - 180-day generic (first-applicant Paragraph IV) exclusivity from first commercial marketing.
Compute the dates
Enter your confirmed FDA and PTO dates and read the controlling expiration in the browser - nothing is uploaded. Route the result to a Sandbox workspace, a Worklog matter, or a Gate client portal.