Drybench Patent.
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE, NDA 200678
The patents and exclusivities FDA's Orange Book lists for NDA 200678 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 11 Oct 2027 to 11 Oct 2027, each by its own rule; no one date stands for this product.
- Earliest listed date
- 11 Oct 2027M-14 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 212–214
- Latest listed date
- 11 Oct 2027M-14 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 212–214
- Latest substance patent
- None listed
- Latest listed patent
- None listed
- Latest exclusivity
- 11 Oct 2027M-14 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 212–214
Products
Each product number FDA lists under NDA 200678, as listed. The sections below name products by these numbers.
Product 001 · KOMBIGLYZE XR
- Dosage form; route
- TABLET, EXTENDED RELEASE;ORAL
- Strength
- 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
- Approval date as listed
- 5 Nov 2010
- Type as listed
- DISCN
- Applicant as listed
- ASTRAZENECA AB
Product 002 · KOMBIGLYZE XR
- Dosage form; route
- TABLET, EXTENDED RELEASE;ORAL
- Strength
- 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
- Approval date as listed
- 5 Nov 2010
- Type as listed
- DISCN
- Applicant as listed
- ASTRAZENECA AB
Product 003 · KOMBIGLYZE XR
- Dosage form; route
- TABLET, EXTENDED RELEASE;ORAL
- Strength
- 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
- Approval date as listed
- 5 Nov 2010
- Type as listed
- DISCN
- Applicant as listed
- ASTRAZENECA AB
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
The Orange Book capture of 14 October 2026 lists no patent for NDA 200678.
Listed exclusivities
Each exclusivity FDA lists for NDA 200678, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-14 exclusivity
exclusivity.txt lines 212–214- Date
- 11 Oct 2027
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002, 003
Paragraph IV list rows giving NDA 200678
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 200678, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 200678
Saxagliptin Hydrochloride and Metformin Hydrochloride · Extended-release Tablets · 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg
RLD/NDA as listed: Kombiglyze XR 200678- First PIV submission
- 31 Jul 2013
- ANDAs
- 3
- 180-day status
- Extinguished
- Decision posted
- 7 Aug 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 31 Jul 2023
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week