First-Filer Exclusivity Timeline and Upcoming Generic Entrants
The end of 180-day exclusivity marks the beginning of broader generic competition. Track who holds the advantage today and who is positioned to enter next.
ANDA submitted
6
Para IV filings received by FDA for the drug Sitagliptin phosphate
Potential first applicants
Strengths
3
Distinct dosage strengths challenged across all Para IV filings
Dosage forms covered
180-day exclusivity rights
2
Company eligible for first-filer exclusivity(Patent Challenge - PC)
First filer
Days until market opens
Unlock
Days remaining until exclusivity expires and subsequent filers may enter
Market Expansion
Para IV First Filers with Exclusivity Rights
| Applicant | Approval Date | Launch Date | Strengths | Last Patent Expiration |
|---|---|---|---|---|
| SANDOZ INC | Dec 30, 2025 | - |
EQ 25MG BASE | TABLET | ORAL
EQ 100MG BASE | TABLET | ORAL
EQ 50MG BASE | TABLET | ORAL
| Nov 24, 2026 |
| APOTEX INC | Dec 30, 2025 | - |
EQ 100MG BASE | TABLET | ORAL
EQ 50MG BASE | TABLET | ORAL
EQ 25MG BASE | TABLET | ORAL
| Nov 24, 2026 |
Launch Timeline
STEP 01
Oct 18, 2010
The company files its ANDA and Paragraph IV certification, initiating the regulatory pathway toward approval, exclusivity eligibility, and eventual market entry.
Para IV Filed Early Mover
STEP 03
Pending
With market launch, the first filer converts its regulatory advantage into commercial opportunity, gaining access to the generic market ahead of competing manufacturers.
Market Entry Exclusivity Starts
Para IV Filed
Applicant Approval
Launch Date
Exclusivity Ends
STEP 02
Dec 30, 2025
This milestone marks the FDA's approval of the first-filer's ANDA, bringing the company one step closer to commercial launch and activation of its exclusivity rights.
Launch Eligible FDA Approved
STEP 04
Unlock
The day the market opens to broader generic competition and the first-filer's exclusive advantage ends.
Click To See When the Market Opens
Expected Generic Entrants After Exclusivity
Identify potential market entrants, first-filer dynamics, and the competitive landscape expected to emerge following exclusivity expiration.
ANDA submitted
11
Para IV filings received by FDA for the drug Macitentan
Potential first applicants
Strengths
1
Distinct dosage strengths challenged across all Para IV filings
Dosage forms covered
180-day exclusivity rights
4
Company eligible for first-filer exclusivity(Patent Challenge - PC)
First filer
Days until market opens
Unlock
Days remaining until exclusivity expires and subsequent filers may enter
Market Expansion
Para IV First Filers with Exclusivity Rights
| Applicant | Approval Date | Launch Date | Strengths | Last Patent Expiration |
|---|---|---|---|---|
| ZYDUS LIFESCIENCES GLOBAL FZE | Apr 06, 2021 | - |
10MG | TABLET | ORAL
| Apr 18, 2029 |
| TEVA PHARMACEUTICALS USA INC | Apr 06, 2021 | - |
10MG | TABLET | ORAL
| Apr 18, 2029 |
| LAURUS LABS LTD | Apr 06, 2021 | - |
10MG | TABLET | ORAL
| Apr 18, 2029 |
| LEPU PHARMACEUTICAL TECHNOLOGY CO LTD | Apr 06, 2021 | - |
10MG | TABLET | ORAL
| Apr 18, 2029 |
Launch Timeline
STEP 01
Oct 18, 2017
The company files its ANDA and Paragraph IV certification, initiating the regulatory pathway toward approval, exclusivity eligibility, and eventual market entry.
Para IV Filed Early Mover
STEP 03
Pending
With market launch, the first filer converts its regulatory advantage into commercial opportunity, gaining access to the generic market ahead of competing manufacturers.
Market Entry Exclusivity Starts
Para IV Filed
Applicant Approval
Launch Date
Exclusivity Ends
STEP 02
Apr 06, 2021
This milestone marks the FDA's approval of the first-filer's ANDA, bringing the company one step closer to commercial launch and activation of its exclusivity rights.
Launch Eligible FDA Approved
STEP 04
Unlock
The day the market opens to broader generic competition and the first-filer's exclusive advantage ends.
Click To See When the Market Opens
Expected Generic Entrants After Exclusivity
Identify potential market entrants, first-filer dynamics, and the competitive landscape expected to emerge following exclusivity expiration.
ANDA submitted
1
Para IV filings received by FDA for the drug Azilsartan kamedoxomil
Potential first applicants
Strengths
2
Distinct dosage strengths challenged across all Para IV filings
Dosage forms covered
180-day exclusivity rights
1
Company eligible for first-filer exclusivity(Patent Challenge - PC)
First filer
Days until market opens
Unlock
Days remaining until exclusivity expires and subsequent filers may enter
Market Expansion
Para IV First Filers with Exclusivity Rights
| Applicant | Approval Date | Launch Date | Strengths | Last Patent Expiration |
|---|---|---|---|---|
| LUPIN LTD | Jul 20, 2022 | - |
EQ 80MG MEDOXOMIL | TABLET | ORAL
EQ 40MG MEDOXOMIL | TABLET | ORAL
| Mar 26, 2028 |
Launch Timeline
STEP 01
Apr 10, 2020
The company files its ANDA and Paragraph IV certification, initiating the regulatory pathway toward approval, exclusivity eligibility, and eventual market entry.
Para IV Filed Early Mover
STEP 03
Pending
With market launch, the first filer converts its regulatory advantage into commercial opportunity, gaining access to the generic market ahead of competing manufacturers.
Market Entry Exclusivity Starts
Para IV Filed
Applicant Approval
Launch Date
Exclusivity Ends
STEP 02
Jul 20, 2022
This milestone marks the FDA's approval of the first-filer's ANDA, bringing the company one step closer to commercial launch and activation of its exclusivity rights.
Launch Eligible FDA Approved
STEP 04
Unlock
The day the market opens to broader generic competition and the first-filer's exclusive advantage ends.
Click To See When the Market Opens
Expected Generic Entrants After Exclusivity
Identify potential market entrants, first-filer dynamics, and the competitive landscape expected to emerge following exclusivity expiration.