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Boehringer Ingelheim v. Sun Pharmaceutical | Empagliflozin Patent | PatSnap
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Case ID1:21-cv-01487
FiledOct 2021
ClosedJul 2025
Patent Litigation

Boehringer Ingelheim v. Sun Pharmaceutical: Empagliflozin Consent Judgment

Boehringer Ingelheim secured a consent judgment against Sun Pharmaceutical and Ohm Laboratories covering 11 patents protecting JARDIANCE, GLYXAMBI, SYNJARDY XR, and TRIJARDY XR. Sun is enjoined from launching generic empagliflozin products until all asserted patents expire — a resolution reached after 1,377 days of litigation across multiple consolidated Delaware actions.

Resolution time
1377days
1,377 days — nearly 4 years of consolidated multi-product ANDA litigation before resolution
Patents asserted
1
US11090323B2 and 10 further patents asserted across four empagliflozin-based product families
Outcome
Consent Judgment
11 patents found valid, enforceable, and infringed; Sun enjoined until expiry of all asserted patents
Cost ruling
No Cost Award
Dismissed without costs, disbursements, or attorneys’ fees to any party per consent judgment terms
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Multi-patent ANDA blockade secures Boehringer’s entire empagliflozin franchise

Boehringer Ingelheim Corporation and Boehringer Ingelheim International GmbH filed suit against Sun Pharmaceutical Industries, Inc. and Ohm Laboratories, Inc. in the District of Delaware on October 22, 2021, asserting infringement arising from Sun’s ANDA filings seeking approval to market generic versions of JARDIANCE (empagliflozin), GLYXAMBI (empagliflozin/linagliptin), SYNJARDY XR (empagliflozin/metformin ER), and TRIJARDY XR (empagliflozin/linagliptin/metformin ER). The case was one of several consolidated Delaware actions stretching back to 2018, collectively placing 11 patents at issue.

The litigation concluded on July 30, 2025, via a consent judgment entered by Judge Colm F. Connolly. Under its terms, all 11 patents — the ‘938, ‘957, ‘998, ‘637, ‘705, ‘016, ‘379, ‘172, ‘120, ‘449, and ‘323 patents — were declared valid, enforceable, and infringed by Sun’s ANDA products. Sun and its successors are permanently enjoined from making, selling, importing, or distributing the infringing products in the United States until each patent’s expiry, including any patent term extension, adjustment, or pediatric exclusivity.

The nearly four-year duration across multiple consolidated dockets suggests complex multi-product negotiations rather than a swift capitulation, consistent with Boehringer seeking to protect a franchise generating substantial revenue. The consent judgment structure — with no cost award and explicit carve-outs permitting Sun to challenge these patents against different products — suggests a negotiated resolution rather than a full trial adjudication. The specific commercial terms of any parallel settlement agreement between the parties remain undisclosed in the public record.

Case at a glance
Case no.1:21-cv-01487
CourtDelaware
JudgeColm F. Connolly
FiledOctober 22, 2021
ClosedJuly 30, 2025
Duration1377 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 1377 days

1,377 days — nearly 4 years of consolidated multi-product ANDA litigation before resolution

Case timeline: Complaint filed OCT 22 2021, SEP–OCT — 1377 days total Horizontal timeline showing the three key events in Boehringer-Ingelheim v Sun Pharmaceutical Industries, Inc. from filing to resolution. Source: PACER, Delaware District Court. OCT 22 2021 Complaint filed Pre-trial proceedings JUL 30 2025 Consent Judgment 1377 DAYS TOTAL
Consent Judgment terms

Consent judgment entered: what the order means for both parties

Legal mechanism

Consent judgment is a court-enforceable negotiated order

A consent judgment is a binding court order jointly agreed by the parties, carrying the same enforcement weight as a litigated verdict. Here, the court formally declares 11 patents valid, enforceable, and infringed — not as a finding after trial, but as a stipulated legal conclusion. Crucially, any future breach of the injunction can be pursued directly in the Delaware District Court, with both parties having waived venue and personal jurisdiction defenses.

Stipulated infringement finding
Patent holder outcome

Boehringer secures injunctive protection across its full SGLT-2 franchise

Boehringer Ingelheim obtained the broadest available relief short of a jury verdict: a permanent injunction blocking Sun from entering the market with any of the five ANDA product families until all 11 patents expire. The order also allows Boehringer to return to court if additional regulatory exclusivities are granted, future-proofing the protection. No cost award limits the financial exposure of the resolution.

Full injunction until patent expiry
Challenger outcome

Sun retains rights to challenge patents on non-ANDA products

Sun and Ohm are barred from commercialising the five ANDA product lines in the United States for the duration of all 11 patents. However, the consent judgment explicitly preserves Sun’s right to challenge the validity, enforceability, and infringement of these patents in connection with any product not described in the five ANDAs at issue. This carve-out suggests the settlement was carefully negotiated to limit — but not entirely foreclose — Sun’s future IP positioning.

Market entry blocked; challenge rights preserved
Commercial implications

JARDIANCE franchise shielded from generic competition until patent cliff

With 11 patents upheld across four commercial products, Boehringer’s empagliflozin franchise — which includes the blockbuster JARDIANCE and its combination successors — faces no generic competition from Sun through the patent term. For the broader SGLT-2 inhibitor sector, the outcome reinforces that layered multi-patent protection strategies can effectively extend exclusivity across product families. Rival generic filers and formulation developers should note the explicit product-specific carve-out as a potential litigation pathway.

Generic entry delayed; franchise protected
Legal analysis based on PACER docket records for case 1:21-cv-01487 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBoehringer-IngelheimIndividualGlobal pharmaceutical innovator — holder of 11 empagliflozin-related patents including US11090323B2Search in Eureka ↗
Co-PlaintiffBoehringer Ingelheim CorporationCompanySearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim International, GMBHCompanySearch in Eureka ↗
DefendantSun Pharmaceutical Industries, Inc.CompanyGeneric drug manufacturer and subsidiary Ohm Laboratories seeking ANDA approval for empagliflozin productsSearch in Eureka ↗
Co-DefendantOhm Laboratories, Inc.CompanySearch in Eureka ↗
Co-DefendantSun Pharmaceutical Industries, 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 counselCharles B. KleinAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselDavid A. BilsonAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselJason Z. PesickAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselJohn C. Phillips , Jr.AttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselJovial WongAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant law firmPhillips, McLaughlin & Hall PALaw FirmRepresenting Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Presiding judgeJudge Colm F. ConnollyJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“IT IS HEREBY ORDERED, ADJUDGED AND DECREED that: 1. 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-01487, Delaware District Court

The consent judgment’s operative language — that the 11 patents ‘are valid, enforceable, and infringed’ — constitutes a stipulated court finding, not a merits adjudication after trial. This distinction matters: the patents were not tested through claim construction, expert testimony, or cross-examination. The explicit carve-out permitting Sun to challenge these same patents for different products underscores that the infringement finding is product-specific and ANDA-limited. The court’s retained jurisdiction to enforce the order and award preliminary injunctive relief for any breach gives Boehringer a swift enforcement mechanism if Sun attempts a premature launch.

PACER case 1:21-cv-01487 · Public docket record Explore in Eureka ↗
Patent at issue

US11090323B2 — Empagliflozin pharmaceutical compositions

Publication No.US11090323B2
Application No.US16/288192
Patent details
ProductEmpagliflozin pharmaceutical compositions for treating type 2 diabetes
Cited in actionOctober 22, 2021

US11090323B2, filed under application number US16/288192, is one of 11 patents asserted by Boehringer Ingelheim in this litigation, covering empagliflozin-based pharmaceutical compositions. Empagliflozin is an SGLT-2 inhibitor approved for treatment of type 2 diabetes and, subsequently, heart failure and chronic kidney disease. The ‘323 patent, like the others in the asserted portfolio, protects specific formulation and composition aspects of the empagliflozin franchise, supporting Boehringer’s JARDIANCE, GLYXAMBI, SYNJARDY XR, and TRIJARDY XR product lines.

The breadth of the 11-patent portfolio asserted in this consolidated litigation — spanning the base empagliflozin compound, fixed-dose combinations with linagliptin and metformin, and extended-release formulations — reflects a classic evergreening and layering strategy in pharmaceutical IP. For competitors developing SGLT-2 inhibitor generics or follow-on therapies, the consent judgment signals that any ANDA filer must contend with a deep, multi-layer patent estate that has now been judicially stipulated as valid and enforceable against Sun’s specific product profiles.

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Freedom to operate

Should you run an FTO against US11090323B2 and the empagliflozin patent portfolio?

Any company developing generic empagliflozin tablets, empagliflozin/linagliptin combinations, or empagliflozin/metformin extended-release formulations should treat this consent judgment as a high-priority FTO trigger. The 11 patents upheld here cover a wide formulation and combination space — and while the stipulated infringement finding applies only to Sun’s five ANDAs, the underlying patent claims remain enforceable against all third parties. Formulators, CDMO partners, and generic filers outside the Sun ANDA set face the same patent landscape without the benefit of Sun’s negotiated carve-out.

PatSnap Eureka’s FTO Search Agent can map the full Boehringer Ingelheim empagliflozin patent portfolio against your specific product formulation, dosage form, and route of administration — identifying claim overlap, expiry dates including potential pediatric exclusivity extensions, and any post-grant proceedings. Eureka’s litigation overlay also flags which patents have been asserted in ANDA cases, helping your team prioritise freedom-to-operate risk before ANDA filing or product launch decisions.

PatSnap Eureka FTO Search

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Related litigation

Similar ANDA patent cases: SGLT-2 inhibitor litigation in Delaware

Explore related ANDA infringement actions involving SGLT-2 inhibitors and empagliflozin patents litigated in the District of Delaware.

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Strategic implications

What this case signals for the SGLT-2 inhibitor IP landscape

A multi-patent consent judgment across four empagliflozin products sets a high bar for generic entry into a blockbuster diabetes franchise.

Layered patent portfolios can block generic entry across entire drug families

Boehringer’s ability to assert 11 patents spanning the base compound, combinations, and extended-release formulations demonstrates how a coordinated ANDA litigation strategy across consolidated cases can protect an entire franchise. Generic challengers face not just one invalidity argument but a portfolio-wide defense burden.

Consent judgments without cost awards signal negotiated market-access deals

The absence of any attorneys’ fee or cost award, combined with the product-specific carve-out, is consistent with an agreed entry date tied to specific patent expirations rather than a pure litigation defeat. Pharma IP teams should read these structural signals when assessing the real competitive timeline for generic launch.

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Full strategic analysis in PatSnap Eureka
Unlock gated insights on SGLT-2 inhibitor patent strategy, Delaware ANDA litigation trends, and Sun’s future challenge vectors.
Generic entry timelineSGLT-2 portfolio risk mapPediatric exclusivity impact
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Frequently asked questions

Boehringer-Ingelheim v Sun — key questions answered

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Monitor the empagliflozin patent estate before your next ANDA filing

With 11 patents upheld across four commercial products, the empagliflozin patent landscape demands continuous monitoring. Use PatSnap Eureka to run FTO searches, track patent expiry extensions, and receive alerts on new ANDA filings or IPR petitions against the Boehringer portfolio.

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