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Boehringer Ingelheim v. Sun Pharmaceutical — SYNJARDY XR Patent Case | PatSnap
Explore in Eureka
Case ID1:21-cv-00356
FiledMar 2021
ClosedJul 2025
Patent Litigation

Boehringer Ingelheim v. Sun Pharmaceutical: SYNJARDY XR Consent Judgment After 1,604 Days

Boehringer Ingelheim secured a consent judgment across 11 patents covering SYNJARDY XR (empagliflozin/metformin extended-release tablets) after Sun Pharmaceutical filed ANDAs seeking to launch a generic version. The Delaware District Court entered an injunction barring Sun from commercialising the ANDA products until all 11 patents expire, across a sprawling multi-case consolidation spanning more than four years.

Resolution time
1604days
1,604 days — above average for ANDA patent cases in D. Del., reflecting multi-case consolidation
Patents asserted
4
US9949998B2, US10596120B2, US7579449B2, US10258637B2 and 7 further patents asserted
Outcome
Consent Judgment
11 patents held valid, enforceable, and infringed; Sun enjoined until last patent expiry
Cost ruling
No Costs Awarded
Dismissed without costs, disbursements, or attorneys’ fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

SYNJARDY XR: Multi-patent ANDA battle ends in sweeping consent judgment

Boehringer Ingelheim Corporation and Boehringer Ingelheim International GmbH filed suit in the District of Delaware on 9 March 2021 against Sun Pharmaceutical Industries Limited, Sun Pharmaceutical Industries Inc., and Ohm Laboratories Inc., asserting infringement of multiple patents covering SYNJARDY XR — the brand-name empagliflozin/metformin hydrochloride extended-release combination tablet indicated for type 2 diabetes. The action arose from Sun’s submission of ANDA Nos. 212343, 212339, 214843, 215873, and 215529 seeking FDA approval to market generic versions of SYNJARDY XR in 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg dosage strengths.

The case closed on 30 July 2025 through a consent judgment entered by Judge Colm F. Connolly. The court found all 11 asserted patents — the ‘938, ‘957, ‘998, ‘637, ‘705, ‘016, ‘379, ‘172, ‘120, ‘449, and ‘323 patents — valid, enforceable, and infringed by Sun’s ANDA products. Sun is permanently enjoined from making, using, selling, offering for sale, importing, or distributing those products in the United States until each patent expires, including any patent term extensions, adjustments, or pediatric exclusivity periods. All remaining claims across seven consolidated civil actions were dismissed without prejudice and without costs to either party.

The 1,604-day duration is consistent with the complexity of multi-case ANDA consolidations in Delaware and the breadth of the patent portfolio asserted — spanning formulation, composition, and method patents. The absence of a costs award and dismissal without prejudice on counterclaims suggests a negotiated resolution preserving some litigation optionality for Sun in connection with non-ANDA products, though the public record does not disclose the commercial terms, if any, underlying the consent arrangement. What remains unknown is whether any licensing arrangement or market-entry date agreement was reached between the parties.

Case at a glance
Case no.1:21-cv-00356
CourtDelaware
JudgeColm F. Connolly
FiledMarch 9, 2021
ClosedJuly 30, 2025
Duration1604 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 1604 days

1,604 days — above average for ANDA patent cases in D. Del., reflecting multi-case consolidation

Case timeline: Complaint filed MAR 9 2021, MAY–JUN — 1604 days total Horizontal timeline showing the three key events in Boehringer-Ingelheim v Sun Pharmaceutical Industries Limited from filing to resolution. Source: PACER, Delaware District Court. MAR 9 2021 Complaint filed Pre-trial proceedings JUL 30 2025 Consent Judgment 1604 DAYS TOTAL
Dismissal terms

Consent judgment entered: what the ruling means for both parties

Legal mechanism

Consent judgment — agreed infringement finding with injunctive relief

A consent judgment is a court-entered order reflecting terms agreed by both parties. Here, Sun agreed that all 11 patents are valid, enforceable, and infringed by its ANDA products, and accepted a permanent injunction. The underlying ANDA claims were dismissed without prejudice, meaning Sun retains the theoretical right to challenge these patents in a different context — for example, for a product not covered by the five listed ANDAs — but cannot market a generic SYNJARDY XR until all patents expire.

Agreed infringement + permanent injunction
Patent holder outcome

Boehringer secures full exclusivity through patent expiry across all dosage strengths

The consent judgment delivers Boehringer Ingelheim its preferred commercial outcome: a court-enforced barrier preventing Sun from launching any ANDA product for SYNJARDY XR across all four dosage strengths until the last of the 11 patents — including any extensions or pediatric exclusivity — expires. The judgment also preserves Boehringer’s ability to apply to court if additional regulatory exclusivities are obtained. No costs were awarded, suggesting a clean commercial resolution rather than an adversarial finding.

Full exclusivity preserved
Challenger outcome

Sun blocked on all five ANDAs; retains narrow rights for non-ANDA product challenges

Sun Pharmaceutical agreed to be enjoined across all five ANDA numbers and all dosage strengths, effectively conceding the SYNJARDY XR generic market to Boehringer for the patent term. Critically, the consent judgment explicitly carves out Sun’s right to challenge the 11 patents in connection with products not described in those ANDAs. This carve-out suggests the settlement was structured to preserve Sun’s optionality for future reformulations or different product configurations while closing off the immediate ANDA pathway.

Enjoined on all ANDAs; narrow carve-out retained
Commercial implications

11-patent wall around empagliflozin/metformin ER raises barrier for all generic entrants

The consent judgment effectively validates Boehringer’s layered IP strategy around SYNJARDY XR — stacking formulation, composition, and method patents to create overlapping exclusivity extending well beyond any single patent. For other generic manufacturers holding or contemplating ANDAs for empagliflozin/metformin ER products, this outcome signals that Boehringer will enforce this portfolio aggressively and that a negotiated consent structure, rather than a full trial, may be the realistic resolution. FTO analyses for empagliflozin combination products should account for all 11 patents and their extension periods.

Layered portfolio strategy validated
Legal analysis based on PACER docket records for case 1:21-cv-00356 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBoehringer-IngelheimIndividualPharmaceutical innovator — holder of SYNJARDY XR empagliflozin/metformin ER patent portfolioSearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim CorporationCompanySearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim International, GMBHCompanySearch in Eureka ↗
DefendantSun Pharmaceutical Industries LimitedCompanyIndian generic pharmaceutical manufacturer seeking U.S. ANDA approval for empagliflozin/metformin ER tabletsSearch in Eureka ↗
Co-DefendantSun Pharmaceutical Industries, Inc.CompanySearch in Eureka ↗
Co-DefendantOhm Laboratories, Inc.CompanySearch in Eureka ↗
Plaintiff counselBrian P. EganAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselJack B. BlumenfeldAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff counselMegan Elizabeth DellingerAttorneyCounsel for Boehringer-IngelheimSearch in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting Boehringer-IngelheimSearch in Eureka ↗
Defendant counselBryce A. CooperAttorneyCounsel for Sun Pharmaceutical Industries LimitedSearch in Eureka ↗
Defendant counselCharles B. KleinAttorneyCounsel for Sun Pharmaceutical Industries LimitedSearch in Eureka ↗
Defendant counselDavid A. BilsonAttorneyCounsel for Sun Pharmaceutical Industries LimitedSearch in Eureka ↗
Defendant counselJohn C. Phillips , Jr.AttorneyCounsel for Sun Pharmaceutical Industries LimitedSearch in Eureka ↗
Defendant counselMichael A. MeneghiniAttorneyCounsel for Sun Pharmaceutical Industries LimitedSearch in Eureka ↗
Defendant law firmPhillips, McLaughlin & Hall PALaw FirmRepresenting Sun Pharmaceutical Industries LimitedSearch in Eureka ↗
Presiding judgeJudge Colm F. ConnollyJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“This Court has jurisdiction over the subject matter of this action and has personal jurisdiction over the parties. 2. The ‘938, ‘957, ‘998 ‘637, ‘705, ‘O 16, ‘379, ‘172, ‘120, ‘449, and ‘323 patents are valid, enforceable, and infringed by the Sun ANDA Products. Notwithstanding the above, nothing precludes Sun from challenging the validity, enforceability, and/or infringement of the ‘938, ‘957, ‘998 ‘637, ‘705, ‘016, ‘379, ‘172, ‘120, ‘449, and ‘323 patents in connection with a product other than a product described in ANDA Nos. 212343, 212339, 214843, 215873, and 215529. 3. Unless specifically authorized or otherwise modified between the parties, Sun, including any of its successors and assigns, is enjoined from making, having made, using, selling, offering to sell, importing or distributing the Sun ANDA Products in the United States, on its own or through any Affiliate, officer, agent, servant, employee or attorney, or through any person in concert or coordination with Sun or its Affiliates, through and until the expiration of the ‘938, ‘957, ‘998, ‘637, ‘705, ‘016, ‘379, ‘172, ‘120, ‘449, and ‘323 patents, including any patent term extension, patent term adjustment, or pediatric exclusivity. If Boehringer becomes entitled to any other regulatory exclusivities that are not referenced herein, Boehringer may apply to the Court for modification of the consent judgment to incorporate such specified exclusivity. 4. This Court retains jurisdiction to enforce performance under this Consent Judgment and any related agreement(s). The Parties agree that, in the event of violation of the terms of this Consent Judgment or any related agreement(s), this Court has personal jurisdiction over the parties and venue for an action to enforce performance under this Consent Judgment, including for a preliminary injunction against the breaching conduct and the Parties hereby waive any and all defenses based on lack of personal jurisdiction or venue. 5. The Complaints in Civil Action Nos. 18-1765-CFC (D. Del.) and 19- 1500-CFC (D. Del.), which have been consolidated with Civil Action No. 18-1689- CFC (D. Del.), and all remaining claims, counterclaims, or affirmative defenses in these actions, are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. 6. The Complaints in Civil Action Nos. 20-1153-CFC (D. Del.), 20-1585- CFC (D. Del.), and 21-356-CFC (D. Del.), which have been consolidated into Civil Action No. 20-1153-CFC (D. Del.), and all remaining claims, counterclaims, or affirmative defenses in these actions, are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. 7. The Complaints in Civil Action Nos. 21-1487-CFC (D. Del.) and 21- 1573-CFC (D. Del.), which have been consolidated with Civil Action No. 21-1485- CFC (D. Del.), and all remaining claims, counterclaims, or affirmative defenses in these actions, are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party.”
Source: PACER Docket, Case 1:21-cv-00356, Delaware District Court

The consent judgment is a negotiated court order rather than a contested ruling, meaning the findings of validity, enforceability, and infringement reflect Sun’s agreement rather than an adjudicated determination. The explicit carve-out preserving Sun’s right to challenge the patents for non-ANDA products is a notable drafting feature — it signals that Sun did not make a blanket concession of invalidity. The injunction running through all patent term extensions and pediatric exclusivity means the effective market exclusion period for Sun’s ANDA products is tied to the last-expiring protection across the 11-patent family, making the commercial timeline difficult to model without independent patent expiry analysis.

PACER case 1:21-cv-00356 · Public docket record Explore in Eureka ↗
Patent at issue

US9949998B2 — empagliflozin/metformin ER formulation and 3 further patents

Publication No.US9949998B2
Application No.US14/918727
Patent details
ProductEmpagliflozin pharmaceutical compositions and SGLT2 inhibitor formulations
Cited in actionMarch 9, 2021

Publication No.US10596120B2
Application No.US15/906414
Patent details
ProductExtended-release metformin combination tablet formulations and manufacturing methods
Cited in actionMarch 9, 2021

Publication No.US7579449B2
Application No.US11/080150
Patent details
ProductSGLT2 inhibitor empagliflozin compound compositions and therapeutic uses
Cited in actionMarch 9, 2021

Publication No.US10258637B2
Application No.US15/918401
Patent details
ProductEmpagliflozin and metformin hydrochloride combination extended-release dosage forms
Cited in actionMarch 9, 2021

The four identified patents — US9949998B2 (app. US14/918727), US10596120B2 (app. US15/906414), US7579449B2 (app. US11/080150), and US10258637B2 (app. US15/918401) — form part of Boehringer Ingelheim’s layered IP estate around SYNJARDY XR. The portfolio spans SGLT2 inhibitor compound claims, pharmaceutical composition claims for empagliflozin/metformin combinations, and extended-release formulation methods. The application dates range from the mid-2000s through to the late 2010s, reflecting successive layers of patent protection built around both the active ingredient and the specific extended-release delivery technology.

For competitors in the SGLT2 inhibitor and type 2 diabetes combination therapy market, this patent family represents a significant FTO challenge. The breadth of the 11-patent portfolio asserted — only four of which are identified in the case data — suggests Boehringer has constructed overlapping claims covering the compound, its formulations, manufacturing processes, and methods of use. Any generic manufacturer considering an ANDA for an empagliflozin-containing combination product, or any innovator developing a competing SGLT2 inhibitor ER combination, should conduct a thorough landscape analysis of the full Boehringer Ingelheim empagliflozin portfolio before committing R&D resources.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should you run an FTO against US9949998B2 and the SYNJARDY XR patent family?

Any pharmaceutical company, generic manufacturer, or drug delivery technology firm working on SGLT2 inhibitor combination products — particularly empagliflozin or metformin extended-release dosage forms — should treat this case as a direct trigger for FTO analysis. The consent judgment validates all 11 patents as enforceable, and the injunction extends through any patent term adjustments and pediatric exclusivity. R&D teams developing competing ER combinations or reformulations should not assume that design-arounds targeting a single patent are sufficient given the portfolio depth demonstrated here.

PatSnap Eureka’s FTO Search Agent allows IP and R&D teams to map the full Boehringer Ingelheim empagliflozin/metformin patent landscape in minutes — identifying claim scope across all asserted and related patents, expiry timelines including PTE and pediatric exclusivity projections, and white-space opportunities for differentiated formulations. Upload your compound or formulation specification and Eureka will generate a prioritised claim-by-claim risk matrix, flagging which of the 11 consent judgment patents pose the highest barrier to your specific product configuration.

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Related litigation

Similar ANDA patent cases: SGLT2 inhibitor and diabetes combination drug litigation

Explore related ANDA infringement actions in the Delaware District Court involving SGLT2 inhibitor and metformin combination drug patents — the same technology domain and venue as this case.

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Boehringer-Ingelheim patent enforcement history, Delaware case history, Boehringer-Ingelheim’s full IP portfolio, and comparable case analysis
Boehringer SGLT2 v. MylanJardiance ANDA litigation historyMetformin ER patent cases D. Del.SGLT2 combo consent judgments
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Strategic implications

What this case signals for the SGLT2 inhibitor combination drug IP landscape

A 1,604-day multi-case consolidation ending in a 11-patent consent judgment sets a clear enforcement template for branded ANDA defence in Delaware.

Portfolio stacking in ANDA defence: 11 patents create durable exclusivity

Boehringer’s strategy of asserting 11 patents across formulation, composition, and method claims forced Sun into a consent structure rather than a viable invalidity defence. Generic manufacturers entering empagliflozin or SGLT2 combination drug markets should conduct deep FTO reviews covering the full Boehringer portfolio — not just the lead compound patents — before filing ANDAs.

Delaware District Court remains the dominant venue for multi-ANDA pharmaceutical consolidations

Seven consolidated civil actions resolved in a single consent judgment illustrates the efficiency — and risk concentration — of D. Del. ANDA consolidations before Judge Connolly. Defendants facing multi-case consolidation in Delaware should assess early whether a negotiated resolution preserving carve-out rights, as Sun obtained here, is preferable to extended litigation against a deep patent portfolio.

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Full strategic analysis in PatSnap Eureka
Unlock gated analysis on SGLT2 combination drug patent strategy and Delaware District Court ANDA enforcement trends.
Pediatric exclusivity timeline riskSun’s carve-out strategy decodedIPR exposure for all 11 patents
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Frequently asked questions

Boehringer-Ingelheim v Sun — key questions answered

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Track empagliflozin patent expiry and ANDA risk with PatSnap Eureka

With 11 patents and multiple term extensions at play, knowing when SYNJARDY XR generic entry becomes viable is complex. PatSnap Eureka maps expiry timelines, PTE status, and litigation risk across the full Boehringer empagliflozin portfolio.

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