Dapagliflozin
SimSon already publishes 177 observed catalogue products for Dapagliflozin while an Orange Book patent expiry falls due 30 September 2041, with 21 organisations publicly associated with FDA filings for the molecule — a near-term SELL opportunity.Source
- DEPTH
- SimSon demonstrates substantial observed public catalogue depth for the molecule.
- Here: SimSon publicly lists 177 products for this API family (threshold 20).
- ADJACENCY
- SimSon has strong adjacent coverage and a small extension would complete an attractive family.
- Here: SimSon's own published impurity series omits 69, 79, 80, 81, 83, 84, 85, 86, 87, 89, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 105, 106, 107; the gap is visible on SimSon's page.
- ACCESS
- Public filings, trials or regulatory records expose identifiable organisations associated with the molecule. This is NOT a claim that any of them is a SimSon customer.
- Here: 21 organisation(s) are publicly associated with filing activity for this molecule. This is not a customer claim.
Take coverage SimSon already has to market.
Take SimSon's existing dapagliflozin coverage to the 21 organisations publicly associated with it.
First step: Review the buyer candidates and mark which are already SimSon accounts — the system cannot tell.
Review buyer candidates- Urgency
- Prepare ahead
- The catalyst is 181 months away, on 2041-09-30.
- Owner
- Not set
- Owner is not set: the system has no access to SimSon's org chart and will not guess one.
- Value — not public
- Cannot be established
- Revenue and margin are not public. This ranks the strength of the public signal, not the size of the prize — see what internal data would settle it.
Why now
Why SimSon
Observed from SimSon’s own public catalogue pages. This measures published coverage, not inventory, and it is not a statement that SimSon can synthesise any specific compound.
SimSon demonstrates adjacent public catalogue coverage: 177 products observed on its own dapagliflozin API page and 3 isotope-labelled products. This is capability evidence; it is not a statement that SimSon can synthesise any specific compound.Source
- Total products
- 177
- Isotope-labelled
- 3
SimSon publishes a numbered impurity series for this API with 69, 79, 80, 81, 83, 84, 85, 86, 87, 89, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 105, 106, 107 absent between published neighbours.
A checkable fact about SimSon’s published page, not an inference.
isotope labelled · impurity standards
Organisations publicly associated with this molecule
Each organisation below is publicly associated with development or filing activity for this molecule through its own FDA application. They are buyer-candidates. The system has no way to know whether any is already a SimSon customer, and does not claim one.
Scroll sideways for the full table
| Organisation | FDA relationship | Application | Status | Date | Evidence |
|---|---|---|---|---|---|
| AIZANT | Generic applicant | ANDA211523 | approval | 06 APR 2026 | View |
| AJANTA PHARMA LTD | Generic applicant | ANDA211482 | approval | 02 SEPT 2026 | View |
| ALEMBIC | Generic applicant | ANDA211560 | approval | 06 APR 2026 | View |
| ALKEM LABS LTD | Generic applicant | ANDA211545 | approval | 06 APR 2026 | View |
| ALKEM LABS LTD | Generic applicant | ANDA211563 | approval | 06 APR 2026 | View |
| AUROBINDO PHARMA | Generic applicant | ANDA211468 | approval | 06 APR 2026 | View |
| AUROBINDO PHARMA | Generic applicant | ANDA211489 | approval | 06 APR 2026 | View |
| BIOCON PHARMA | Generic applicant | ANDA211470 | approval | 06 APR 2026 | View |
| CIPLA | Generic applicant | ANDA211535 | approval | 06 APR 2026 | View |
| INVENTIA | Generic applicant | ANDA211156 | approval | 28 MAY 2026 | View |
| LUPIN | Generic applicant | ANDA211531 | approval | 06 APR 2026 | View |
| LUPIN | Generic applicant | ANDA211579 | approval | 06 APR 2026 | View |
| MACLEODS PHARMS | Generic applicant | ANDA211506 | approval | 06 APR 2026 | View |
| MACLEODS PHARMS | Generic applicant | ANDA211559 | approval | 06 APR 2026 | View |
| MSN | Generic applicant | ANDA211478 | approval | 06 APR 2026 | View |
| MSN | Generic applicant | ANDA211479 | approval | 06 APR 2026 | View |
| MSN | Generic applicant | ANDA211533 | approval | 06 APR 2026 | View |
| SANDOZ | Generic applicant | ANDA211312 | approval | 06 APR 2026 | View |
| SUN PHARM | Generic applicant | ANDA211491 | approval | 21 MAY 2026 | View |
| TEVA PHARMS USA | Generic applicant | ANDA211541 | approval | 06 APR 2026 | View |
| ZYDUS PHARMS | Generic applicant | ANDA211582 | approval | 06 APR 2026 | View |
How this decision was reached
R2C_DEPTH_MARKETSimSon already publishes a material catalogue position and there is live, named commercial activity around the molecule.
SimSon holds 177 observed products and market activity scores 86.7/100.
This is a system recommendation, not system evidence. It was selected by a fixed rule evaluated top to bottom over the values above — no model, no judgement. Change the inputs and the rule changes with them.
SELL — rule R2C_DEPTH_MARKET. SimSon holds 177 observed products and market activity scores 86.7/100.
Opportunity score
- Market activity
- 86.7
- Regulatory catalyst
- 12.0
- Competitor scarcity
- Not scored
- Capability adjacency
- 85.0
- Evidence quality
- 65.8
Why competitor scarcity is not scored
Identity-grade competitor coverage was insufficient across the three suppliers this dimension requires. The 20 weight points it would have carried were removed from the denominator rather than scored as zero, so the remaining dimensions keep their relative influence.
A false competitive gap is materially worse than a missing scarcity score, so the dimension stays unscored until the evidence standard is met.
- Distinct ANDA sponsors
- 15
- Marketed products
- 60
- Distinct trial sponsors
- Not checked
ClinicalTrials.gov disallows our agent on /api/ in its robots.txt. The trial component was omitted from the weighted average rather than scored zero, and no substitute source was used.
Evidence ledger
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationFDA Orange Book data filesobserved
Orange Book patent row
N 202293 product 002
https://www.fda.gov/media/76860/download?attachmentRetrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211582 — ZYDUS PHARMS
ANDA211582; sponsor ZYDUS PHARMS
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211491 — SUN PHARM
ANDA211491; sponsor SUN PHARM
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211523 — AIZANT
ANDA211523; sponsor AIZANT
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211560 — ALEMBIC
ANDA211560; sponsor ALEMBIC
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211506 — MACLEODS PHARMS
ANDA211506; sponsor MACLEODS PHARMS
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211156 — INVENTIA
ANDA211156; sponsor INVENTIA
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211559 — MACLEODS PHARMS
ANDA211559; sponsor MACLEODS PHARMS
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211535 — CIPLA
ANDA211535; sponsor CIPLA
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211489 — AUROBINDO PHARMA
ANDA211489; sponsor AUROBINDO PHARMA
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211563 — ALKEM LABS LTD
ANDA211563; sponsor ALKEM LABS LTD
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211470 — BIOCON PHARMA
ANDA211470; sponsor BIOCON PHARMA
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211482 — AJANTA PHARMA LTD
ANDA211482; sponsor AJANTA PHARMA LTD
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211479 — MSN
ANDA211479; sponsor MSN
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211541 — TEVA PHARMS USA
ANDA211541; sponsor TEVA PHARMS USA
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211312 — SANDOZ
ANDA211312; sponsor SANDOZ
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211478 — MSN
ANDA211478; sponsor MSN
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211531 — LUPIN
ANDA211531; sponsor LUPIN
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211533 — MSN
ANDA211533; sponsor MSN
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211545 — ALKEM LABS LTD
ANDA211545; sponsor ALKEM LABS LTD
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211579 — LUPIN
ANDA211579; sponsor LUPIN
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalU.S. Food and Drug AdministrationopenFDA Drugs@FDAobserved
ANDA211468 — AUROBINDO PHARMA
ANDA211468; sponsor AUROBINDO PHARMA
https://api.fda.gov/drug/drugsfda.json?search=openfda.substance_name%3A%22dapagliflozin%22&limit=100Retrieved 13 SEPT 2026
- Retrieval datePrimaryLive retrievalSimSon Pharma LimitedSimSon public catalogueobserved
SimSon catalogue coverage — dapagliflozin
177 products observed on https://www.simsonpharma.com/products/Dapagliflozin
https://www.simsonpharma.com/products/DapagliflozinRetrieved 13 SEPT 2026
What internal SimSon data would change this decision?
Everything above was built from information anyone can retrieve. The scoring is deterministic and the evidence is cited — but each of the following would sharpen this recommendation materially, and none of it is public.
Realised selling price and margin per catalogue item
Every opportunity here is ranked by signal strength, never by profit. A high-scoring molecule may be one SimSon sells at its thinnest margin.
Would be resolved by: SimSon price book and cost model
Historical RFQs and enquiry conversion
The best predictor of the next order is usually the last unconverted enquiry. None of that is public.
Would be resolved by: SimSon CRM and enquiry log
Existing customer relationships
The organisations listed as buyer-candidates may already be SimSon customers. The system has no way to tell, which is exactly why it never calls them leads.
Would be resolved by: SimSon customer master
Inventory and lead time
A listed product is not an in-stock product. A SELL recommendation assumes availability the catalogue does not state.
Would be resolved by: SimSon ERP
Actual competitor pricing, stock and terms
Public catalogues show listings, never terms. Even where a competitor listing is observed, it says nothing about price or availability.
Would be resolved by: Not public — sales intelligence or direct enquiry
competitor scarcity is NOT SCORED (0 of the 3 required suppliers hold an identity-grade verdict); the ClinicalTrials.gov trial-sponsor component is omitted from market activity because that publisher's robots.txt disallows our agent on /api/ — omitted, not scored zero; catalogue depth is capability evidence only and carries no demand claim.Source