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SimSonGrowth Intelligence

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.
Recommended action
sell

Take coverage SimSon already has to market.

60.3/ 100 opportunity score
Medium confidenceMedium because competitor scarcity could not be scored from public evidence.
Recommended move

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

  1. patent expirySource

    Orange Book patent 12409186*PED expiry

    base 80 × 0.15 recency = 12 / 100

Why SimSon

Observed from SimSon public catalogue · 13 SEPT 2026
177publicly observed catalogue products for dapagliflozin

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
Observable gap in SimSon’s own series

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.

Publicly claimed classes touched

isotope labelled · impurity standards

Organisations publicly associated with this molecule

21 public filing associations

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

OrganisationFDA relationshipApplicationStatusDateEvidence
AIZANTGeneric applicantANDA211523approval06 APR 2026View
AJANTA PHARMA LTDGeneric applicantANDA211482approval02 SEPT 2026View
ALEMBICGeneric applicantANDA211560approval06 APR 2026View
ALKEM LABS LTDGeneric applicantANDA211545approval06 APR 2026View
ALKEM LABS LTDGeneric applicantANDA211563approval06 APR 2026View
AUROBINDO PHARMAGeneric applicantANDA211468approval06 APR 2026View
AUROBINDO PHARMAGeneric applicantANDA211489approval06 APR 2026View
BIOCON PHARMAGeneric applicantANDA211470approval06 APR 2026View
CIPLAGeneric applicantANDA211535approval06 APR 2026View
INVENTIAGeneric applicantANDA211156approval28 MAY 2026View
LUPINGeneric applicantANDA211531approval06 APR 2026View
LUPINGeneric applicantANDA211579approval06 APR 2026View
MACLEODS PHARMSGeneric applicantANDA211506approval06 APR 2026View
MACLEODS PHARMSGeneric applicantANDA211559approval06 APR 2026View
MSNGeneric applicantANDA211478approval06 APR 2026View
MSNGeneric applicantANDA211479approval06 APR 2026View
MSNGeneric applicantANDA211533approval06 APR 2026View
SANDOZGeneric applicantANDA211312approval06 APR 2026View
SUN PHARMGeneric applicantANDA211491approval21 MAY 2026View
TEVA PHARMS USAGeneric applicantANDA211541approval06 APR 2026View
ZYDUS PHARMSGeneric applicantANDA211582approval06 APR 2026View

How this decision was reached

sell
Rule fired
R2C_DEPTH_MARKET

SimSon 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

Weighted over 80 of 100 available points · audit-01-phase2-v1
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.

Market activity components
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

23 items · 23 primary
  1. Retrieval datePrimaryLive retrieval
    U.S. Food and Drug AdministrationFDA Orange Book data filesobserved

    Orange Book patent row

    N 202293 product 002

    https://www.fda.gov/media/76860/download?attachment

    Retrieved 13 SEPT 2026

  2. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  3. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  4. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  5. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  6. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  7. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  8. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  9. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  10. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  11. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  12. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  13. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  14. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  15. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  16. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  17. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  18. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  19. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  20. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  21. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  22. Retrieval datePrimaryLive retrieval
    U.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=100

    Retrieved 13 SEPT 2026

  23. Retrieval datePrimaryLive retrieval
    SimSon Pharma LimitedSimSon public catalogueobserved

    SimSon catalogue coverage — dapagliflozin

    177 products observed on https://www.simsonpharma.com/products/Dapagliflozin

    https://www.simsonpharma.com/products/Dapagliflozin

    Retrieved 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

Limitations recorded for this opportunity

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

Computed 14 SEPT 2026Weights audit-01-phase2-v1Run phase2-current-evidence-v1