Health Canada generic semaglutide submission review: the nine filings still waiting

Health Canada’s Generic Submissions Under Review list is the only public record of which drug makers are still waiting for a yes. It names nine semaglutide files, each with the month Health Canada accepted it, and nothing more.¹ This page puts the names in one place and explains what the list can and cannot tell you.

If you are watching for more competition, the short version is this: more makers are in line, but none has a published decision date. Prices and supply depend on approvals, launches and public-plan deals, and only the first of those shows up on this list.

Which generic semaglutide filings is Health Canada reviewing?

Nine abbreviated new drug submissions (ANDS) for semaglutide sit on Health Canada’s Generic Submissions Under Review list, current as of August 31, 2026.¹ All nine are filed under the therapeutic group “Drugs used in diabetes”.¹

Here is the same list in order of acceptance, using the company names exactly as Health Canada prints them:¹

1. Sandoz Canada Incorporated, November 2024
2. Taro Pharmaceuticals Inc, June 2025
3. Teva Canada Limited, August 2025
4. AA Pharma Inc, November 2025
5. Zydus Lifesciences Limited, May 2026
6. Sandoz Canada Incorporated, June 2026
7. Apotex Inc, July 2026
8. Angita Pharma Inc, July 2026
9. Vimy Pharmaceuticals Inc., August 2026

What the review list shows, and what it leaves out

The list gives four things per row: the medicinal ingredient, the therapeutic area, the company, and the year and month the file entered review.¹ It does not give a product name, a strength, a dosage form or the brand being copied. It does not give a target date either.

Company names only appear for files accepted on or after April 1, 2024. Older rows read “not available”.¹

All nine semaglutide rows fall after that cut-off, which is why every one is named. Health Canada says it updates the list monthly, and the version live on October 22, 2026 still carried the August 31 data.¹

Our read: treat the list as a queue, not a forecast. A row tells you a company filed and Health Canada accepted the file into review. It does not tell you the file is close to approval.

How many generic semaglutide products are approved so far?

Health Canada has issued a Notice of Compliance (NOC) for six generic semaglutide products, from four companies.^2,3 All six are injectable pens, and none delivers a 2 mg dose.²

Dates in this table come from Health Canada’s NOC database.³ An approval is not a launch.

In the Drug Product Database on October 22, 2026, only Dr. Reddy’s Semaglutide Injection and Apo-Semaglutide showed as Marketed. Sevmia, both Aspen products and Sandoz showed as Approved with no market date.²

Marketed is a database status, not a stock count: Dr. Reddy’s reported a shortage on July 10, 2026, and its supply has been halted since.⁴

For which of these you can actually fill today, see our guide to generic Ozempic in Canada.

How the count of pending filings changed in 2026

The number of semaglutide files waiting has stayed close to nine for a year, but the names behind it have changed. Approvals took files off the list, and new filings put fresh ones on.

• Late December 2025: nine submissions were under review. The Canadian Press, reporting on January 2, named Sandoz, Apotex, Teva, Taro and Aspen among them.⁵
• April 28, 2026: Health Canada approved Dr. Reddy’s and said “eight other submissions” were still being reviewed.⁶
• May 1, 2026: with Apo-Semaglutide approved, the department said seven others remained.⁷
• June 29, 2026: with Sevmia approved, it said six others remained.⁸
• August 31, 2026: the public list showed nine again, because files accepted from May to August had been added.¹

Aspen is the clearest case of a name moving off the queue. It was named in the December reporting, received NOCs on July 17 and August 25, 2026, and does not appear on the August 31 list.^5,3,1

Why did the queue start in 2024? Canada’s data protection rules barred generic filings for semaglutide until January 4, 2024, and barred approvals until data protection ended on January 4, 2026.⁹ Sandoz’s November 2024 file, the oldest on the list, arrived ten months after filing opened.

Sandoz semaglutide in Canada: approved and still filing

Sandoz is the only company that holds a semaglutide approval and still has files on the review list. It received an NOC for Sandoz Semaglutide on September 16, 2026, and Health Canada’s list shows two more Sandoz files, accepted in November 2024 and June 2026.^3,1

The September approval is a labelling-only NOC, described in the NOC database as an administrative licensing agreement between two manufacturers.³ The database does not name the other manufacturer.

Sandoz announced the approval on September 18 and called the product ready for an “upcoming launch” without giving a date.¹⁰

The two Sandoz rows on the list were still open on August 31, two weeks before that NOC.¹ Health Canada does not link list rows to approvals, so we cannot tell you whether the September NOC will close one of them. The next monthly update should show it.

Teva, Taro, AA Pharma, Zydus, Angita and Vimy

None of these six companies holds a semaglutide NOC or a DIN as of October 22, 2026.^2,3 What follows is all the public record says about each one’s Canadian semaglutide filing. We have left out guesses about strengths, brands and timing.

Teva semaglutide in Canada

Teva Canada Limited’s file entered review in August 2025, and Teva was one of the five names in the January 2026 reporting on the queue.^1,5 As of October 22, 2026, fourteen months after acceptance, it has no DIN.²

Taro semaglutide

Taro Pharmaceuticals’ file was accepted in June 2025, making it the oldest non-Sandoz entry on the list.¹ Taro was also named in the January reporting.⁵

AA Pharma

AA Pharma Inc’s file was accepted in November 2025.¹ We found no public statement from the company about it.

Zydus semaglutide in Canada

Zydus Lifesciences Limited’s file entered review in May 2026.¹ It is the first filing on the list accepted after Canada’s first generic approval on April 28, 2026.^6,1

Angita Pharma

Angita Pharma Inc’s file was accepted in July 2026, the same month as Apotex’s newest filing.¹

Vimy Pharmaceuticals semaglutide

Vimy Pharmaceuticals Inc. holds the newest row, accepted in August 2026.¹ In January, The Globe and Mail described Vimy as a new company, founded by two former Novo Nordisk Canada executives, that would soon file and planned to have its product made at a plant in Edmonton.¹¹ The list now confirms that filing went in.

The newer Apotex filing

Apotex already holds two semaglutide approvals: Apo-Semaglutide and Sevmia.³ Its July 2026 row is a separate, newer file.¹

The list does not say what product it covers, and Apotex has not said either, so we will not guess. Our generic Wegovy page covers where Sevmia stands.

Two other generic makers come up often in searches. We found no Canadian semaglutide filing from Biocon or Hikma on the list or in news coverage.¹

How long does a generic semaglutide review take?

There is no published clock for the files on this list. The one public timing figure is from the first approval: Health Canada said it finished the Dr. Reddy’s review within its 180-day target.⁶

The list itself shows that many files take longer than that. On August 31, 2026, Sandoz’s first file had been in review for about 21 months, Taro’s for about 14 and Teva’s for about 12.¹ Those are counted from the month of acceptance to the list date.

Part of the Sandoz wait was set by law, since no generic could be approved before data protection ended in January 2026.⁹

Health Canada does not explain the wait on any single file. Its own notes say a file stays listed through interim negative decisions and regulatory holds, so a long-listed row can mean many things.¹ Our read: a long wait on the list is not a sign of a problem with the product, and a short wait is not a promise of approval.

Will more generic semaglutide approvals lower the price?

Possibly, but the public-plan price has already dropped hard, and no rule sets the next step. Ontario pays $78.14 per generic pen, which is 34% of its Ozempic list price of $227.94.¹²

Canada’s public drug plans use a tiered pricing framework for generics, run by the pan-Canadian Pharmaceutical Alliance (pCPA).^13,14 The general rule is that the price ceiling falls as more makers enter.

With two generics it is 50% of the brand reference price, and with three or more it is 35% for products that are not oral solids, such as injectable pens.¹³ The pCPA has extended the framework through 2028.¹⁴

That framework has not yet been applied to semaglutide in public. The pCPA’s generic categories report dated September 18, 2026 does not list semaglutide at all.¹⁵ So there is no published tier and no published brand reference price to work from.

For people paying cash, the picture is different, and the Health Canada generic semaglutide submission review is only the first step toward a cheaper pen at the counter. CBC reported in May 2026 that generics had cut the price to about $100 a month, and a Windsor-Essex pharmacist expected it could fall to about $75 a month as more generics arrived.¹⁶ That was one pharmacist’s expectation, not a forecast.

Our read: more approved makers should help most with supply, since a pharmacy with three sources is less exposed to one maker’s shortage. Cash prices may ease too, but only once new products are actually in stock. See today’s counter prices on our generic semaglutide price page.

What about generic Rybelsus and a generic 2 mg pen?

Neither exists in Canada today. As of October 22, 2026, every semaglutide tablet in the Drug Product Database belongs to Novo Nordisk, no generic oral semaglutide has an NOC, and no approved generic pen delivers a 2 mg dose.^2,3

Can the review list tell you whether either is coming? No.

It does not record dosage form or strength, so any of the nine semaglutide files could be a pen, a tablet or a new strength.¹ Anyone telling you a generic Rybelsus is “under review” in Canada is reading more into the list than it contains.

How we track the Health Canada generic semaglutide submission review

We follow three Health Canada records. The Drug Product Database gives each product’s status, and this site syncs it on every build (last synced November 3, 2026), while the NOC database gives approval dates.^2,3

The third record is the Generic Submissions Under Review list. We check it after each monthly update and change this page when a row is added or drops off.¹ When a pending file turns into an approval, it moves to the approved table above and onto our news timeline.

You can check any company yourself in about two minutes. Search “semaglutide” in Health Canada’s Drug Product Database and look at the company column and the status.² A new company name with a DIN means an approval has landed, even before any press release.

If the company is missing from the database but still on the review list, its file is still open.^2,1 Health Canada says a file leaves the list only when it is cancelled or reaches a final decision, and it points readers to the NOC database to see approvals.¹

Approval also does not guarantee steady supply, as the Dr. Reddy’s halt showed. Our Dr. Reddy’s semaglutide page follows that story month by month.

What the review list means for you right now

If you need semaglutide this month, the review list changes nothing for you. Your options are the generics already on shelves, plus brand Ozempic.

If you are waiting for prices to fall or for more choice at the counter, watch for two events: a new NOC in Health Canada’s database, then a Marketed status with a market date.^2,3 The gap between those two has been long for some makers: Sevmia, Aspen and Sandoz all had approvals but no market date on October 22, 2026.²

Our read: nine files in the queue is good news for long-term supply, but none of them has a date. Plan around what you can fill today, and check back after Health Canada’s next monthly update.