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Boehringer Ingelheim v. Sun Pharma: Empagliflozin ANDA Litigation | PatSnap
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Case ID1:18-cv-01765
FiledNov 2018
ClosedJul 2025
Patent Litigation

Boehringer Ingelheim v. Sun Pharma: 11-Patent Empagliflozin Consent Judgment After 2,456 Days

Boehringer Ingelheim brought ANDA infringement claims against Sun Pharmaceutical over generic versions of Jardiance, Glyxambi, Synjardy, and Trijardy XR, asserting 11 patents spanning empagliflozin chemistry and combination formulations. After 2,456 days of consolidated multi-case litigation, the parties resolved all disputes through a consent judgment entered July 30, 2025, with Sun enjoined from launching until patent expiry.

Resolution time
2456days
6.7 years — well above median ANDA pharma litigation duration in Delaware
Patents asserted
2
US9949998B2 and US8551957B2 among 11 patents asserted covering empagliflozin formulations
Outcome
Consent Judgment
All 11 patents held valid, enforceable, and infringed; Sun enjoined through patent expiry
Cost ruling
No Costs
Dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

A decade-long empagliflozin fortress: how Boehringer locked out Sun Pharma

Filed in November 2018 in the District of Delaware, this action arose from Sun Pharmaceutical’s ANDA filings seeking approval to market generic versions of Boehringer Ingelheim’s blockbuster SGLT2 inhibitor franchise — Jardiance (empagliflozin), Glyxambi (empagliflozin/linagliptin), Synjardy (empagliflozin/metformin), and Trijardy XR (empagliflozin/linagliptin/metformin). Boehringer asserted 11 patents covering the core compound, pharmaceutical compositions, and combination therapies, spanning application dates from multiple filing windows.

The litigation expanded significantly over time, with multiple related Delaware civil actions consolidated under the lead docket. Resolution came on July 30, 2025 via a stipulated consent judgment: Sun conceded that all 11 patents are valid, enforceable, and infringed by its ANDA products, and accepted an injunction prohibiting commercialisation in the United States until expiry of each patent, including any term extensions or pediatric exclusivity. All complaints were dismissed without prejudice and without costs to either side — a structure consistent with a negotiated market-entry settlement rather than a fully contested adjudication.

At 2,456 days, the timeline reflects the complexity of multi-wave ANDA litigation involving stacked formulation and combination patents. The consent judgment’s carve-out — preserving Sun’s right to challenge the 11 patents in connection with products outside these specific ANDAs — suggests the parties negotiated a narrow but commercially decisive resolution. The financial terms of any underlying licence or authorised-generic arrangement, if any exist, remain undisclosed in the public record.

Case at a glance
Case no.1:18-cv-01765
CourtDelaware
JudgeN/A
FiledNovember 8, 2018
ClosedJuly 30, 2025
Duration2456 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 2456 days

6.7 years — well above median ANDA pharma litigation duration in Delaware

Case timeline: Complaint filed NOV 8 2018, MAR–APR — 2456 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. NOV 8 2018 Complaint filed Pre-trial proceedings JUL 30 2025 Consent Judgment 2456 DAYS TOTAL
Consent Judgment terms

Consent judgment entered: what Sun’s concession means for both parties

Legal mechanism

Consent judgment: Sun stipulates validity and infringement

A consent judgment is a court-ordered resolution jointly agreed by the parties, carrying the same legal force as a litigated judgment. Here, Sun stipulated that all 11 Boehringer patents are valid, enforceable, and infringed by its ANDA products. This is a stronger concession than a simple dismissal — it creates an enforceable court record that Sun cannot launch these generics without breaching the injunction, binding Sun’s successors and assigns.

Stipulated — court-ordered injunction
Patent holder outcome

Boehringer secures injunction through all patent expiries

Boehringer obtains a court-enforced exclusion order preventing Sun from making, selling, or importing the ANDA products until the last of the 11 patents expires, including any pediatric exclusivity. The consent judgment also allows Boehringer to return to court if additional regulatory exclusivities arise. Critically, all claims were dismissed without prejudice, preserving Boehringer’s ability to re-litigate if Sun breaches the terms or files new ANDAs outside the agreed scope.

Patent term protection secured
Generic challenger outcome

Sun’s US market entry blocked — but patent challenge rights preserved

Sun is enjoined from commercialising its empagliflozin generic portfolio in the US for the duration of the patent term. However, the consent judgment explicitly preserves Sun’s right to challenge the 11 patents in connection with any product outside these five ANDAs — a meaningful carve-out that signals the parties drew a deliberate boundary. The structure, with no costs awarded, suggests a negotiated commercial resolution rather than a capitulation after adverse litigation findings.

Enjoined; future challenge rights retained
Commercial implications

Empagliflozin exclusivity reinforced across the full product line

The consent judgment covers five ANDAs spanning Jardiance, Glyxambi, Synjardy, Synjardy XR, and Trijardy XR — Boehringer’s entire empagliflozin franchise. With 11 patents confirmed valid and infringed, the market exclusivity wall is substantially reinforced. Other generic filers challenging this portfolio face a dense, court-validated patent landscape. The SGLT2 inhibitor market, valued in the billions annually, remains protected at originator pricing for the foreseeable patent term.

SGLT2 exclusivity wall intact
Legal analysis based on PACER docket records for case 1:18-cv-01765 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBoehringer-IngelheimIndividualGlobal pharmaceutical innovator — holder of empagliflozin (Jardiance) patent portfolioSearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim CorporationCompanySearch in Eureka ↗
Co-PlaintiffBoehringer Ingelheim International, GMBHCompanySearch in Eureka ↗
DefendantSun Pharmaceutical Industries, Inc.CompanyGeneric pharmaceutical manufacturer filing ANDAs for empagliflozin combination productsSearch 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 law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting Boehringer-IngelheimSearch in Eureka ↗
Defendant counselBryce A. CooperAttorneyCounsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗
Defendant counselDavid A. BilsonAttorneyCounsel 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 N/AJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“WHEREAS Plaintiffs Boehringer Ingelheim International GmbH, Boehringer Ingelheim Corporation and Boehringer Ingelheim Pharmaceuticals, Inc. (collectively, "Boehringer") and Defendants Sun Pharmaceutical Industries Limited ("Sun Ltd.") and Sun Pharmaceutical Industries, Inc., ("Sun Inc.") (Sun Ltd. and Sun Inc., collectively, "Sun") have agreed to terms and conditions representing a negotiated resolution of 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.); as well as 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.); as well as 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.); WHEREAS the following definitions shall apply to this Consent Judgment: (i) "the ‘938 Patent" means U.S. Patent No. 7,713,938; (ii) "the ‘957 Patent" means U.S. Patent No. 8,551,957; (iii) "the ‘998 Patent" means U.S. Patent No. 9,949,998; (iv) "the ‘637 Patent" means U.S. Patent No. 10,258,637; (v) "the ‘705 Patent" means U.S. Patent No. 9,155,705; 2 Case 1:18-cv-01765-CFC-SRF Document 23 Filed 07/30/25 Page 2 of 7 PageID #: 255 (vi) "the ‘016 Patent" means U.S. Patent No. 9,415,016; (vii) "the ‘379 Patent" means U.S. Patent No. 10,022,379; (viii) "the’ 172 Patent" means U.S. Patent No. 10,406,172; (ix) "the ‘120 Patent" means U.S. Patent No. 10,596,120; (x) "the ‘449 Patent" means U.S. Patent No. 7,579,449; (xi) "the ‘323 patent" means U.S. Patent No. 11,090,323; (xii) "Sun ANDA Products" means the products described in Abbreviated New Drug Application Nos. 212343, 212339, 214843, 215873, and 215529, including 10 mg and 25 mg empagliflozin tablets as generic versions of J ardiance, 10 mg/5 mg and 25 mg/5 mg empagliflozin/linagliptin tablets as generic versions of Glyxambi, 5 mg/2.5 mg/1000 mg, 10 mg/5 mg/1000 mg, 12.5 mg/2.5 mg/1000 mg, and 25 mg/5 mg/ 1000 mg empagliflozin/linagliptin/metformin hydrochloride extended-release tablets as generic versions of Trijardy XR, 5 mg/I 000 mg, 5 mg/500 mg, 12.5 mg/1000 mg, and 12.5 mg/500 mg empagliflozin/metformin hydrochloride tablets as generic versions of Synjardy, and 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg empagliflozin/metformin hydrochloride extended-release tablets as generic versions of Synjardy XR as existing on the date of this Consent Judgment, and as amended or supplemented from time to time in the ordinary course of business; and 3 Case 1:18-cv-01765-CFC-SRF Document 23 Filed 07/30/25 Page 3 of 7 PageID #: 256 (xiii) "Affiliate" means any entity controlling, controlled by, or under common control with a Party, but only as long as such control continues, where "control" means: (a) the ownership of more than fifty percent (50%) of the equity or beneficial interest of such entity, or the right to vote for or appoint a majority of the board of directors or other governing body of such entity; or (b) the power to directly or indirectly direct or cause the direction of the management and policies of such entity by any means whatsoever. The parties, by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment in this action as follows: 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, 4 Case 1:18-cv-01765-CFC-SRF Document 23 Filed 07/30/25 Page 4 of 7 PageID #: 257 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 5 Case 1:18-cv-01765-CFC-SRF Document 23 Filed 07/30/25 Page 5 of 7 PageID #: 258 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 1:18-cv-01765, Delaware District Court

The consent judgment is notable for its explicit stipulation that all 11 patents are ‘valid, enforceable, and infringed’ — language that goes beyond a standard settlement dismissal. This phrasing creates a court record that Sun cannot easily disavow in future proceedings. The carve-out in paragraph 2, preserving Sun’s challenge rights for products outside the five named ANDAs, was clearly negotiated: it prevents the judgment from being read as a broad admission of patent validity in any context, limiting its preclusive effect to the specific ANDA product set.

PACER case 1:18-cv-01765 · Public docket record Explore in Eureka ↗
Patent at issue

US9949998B2 & US8551957B2 — empagliflozin pharmaceutical compositions

Publication No.US9949998B2
Application No.US14/918727
Patent details
ProductEmpagliflozin pharmaceutical compositions and solid dosage form formulations
Cited in actionNovember 8, 2018

Publication No.US8551957B2
Application No.US12/673327
Patent details
ProductEmpagliflozin compound and SGLT2 inhibitor pharmaceutical preparations
Cited in actionNovember 8, 2018

US9949998B2 (application No. US14/918727) and US8551957B2 (application No. US12/673327) are two of 11 patents Boehringer asserted in this consolidated action. Both relate to empagliflozin — a selective SGLT2 inhibitor approved for type 2 diabetes and, subsequently, heart failure and chronic kidney disease. The patents cover pharmaceutical compositions and formulation aspects of empagliflozin-containing products, sitting within a broader estate that also spans combination therapies with linagliptin and metformin.

Empagliflozin’s commercial trajectory — Jardiance generated over $6 billion globally in recent years — makes this patent estate among the most commercially significant in the cardiovascular-metabolic space. The consent judgment’s confirmation that both patents are valid and infringed reinforces their enforceability against this specific generic challenger. Competitors and ANDA filers working on empagliflozin or SGLT2 inhibitor generics must now account for a court-validated 11-patent wall when assessing freedom-to-operate and litigation risk.

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Freedom to operate

Should your team run an FTO against US9949998B2 and US8551957B2?

Any company developing generic empagliflozin tablets, SGLT2/DPP-4 inhibitor combinations, or metformin co-formulations should treat this consent judgment as a red flag requiring immediate FTO analysis. The 11-patent portfolio confirmed here covers compound, composition, and combination dimensions — meaning narrow design-arounds face compounding hurdles. R&D teams working on Jardiance, Glyxambi, Synjardy, or Trijardy XR equivalents should assess each patent’s claim scope, expiry dates, and any pending continuations before advancing ANDA filings.

PatSnap Eureka’s FTO Search Agent can map the full Boehringer empagliflozin patent family against your proposed formulation, flag active claims posing infringement risk, and surface relevant prior art that could support IPR or inter partes challenge strategies. Given that Sun’s consent judgment preserves challenge rights for non-ANDA products, Eureka can also help identify which claim elements remain contestable in alternative product contexts — enabling a targeted, cost-efficient clearance strategy.

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Related litigation

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Strategic implications

What this case signals for the SGLT2 inhibitor and ANDA IP landscape

An 11-patent consent judgment covering five ANDAs sets a high bar for generic entry into the empagliflozin franchise and signals how layered pharmaceutical patent portfolios function in practice.

Stacked patent portfolios deter generic entry even after prolonged litigation

Boehringer’s 11-patent estate — covering the compound, formulations, and combinations — created a litigation burden that ultimately led Sun to stipulate infringement rather than pursue adjudication to judgment. For IP strategists, this case reinforces the defensive value of layered pharmaceutical patent portfolios, particularly when combination-therapy patents extend beyond compound patent expiry.

Consent judgments with injunctions are strategically superior to voluntary dismissals

Unlike a simple dismissal, this consent judgment creates court-enforceable obligations binding Sun’s successors and assigns. Brand-side IP teams should note this structure as a preferred resolution template in ANDA litigation: it achieves exclusivity enforcement without the cost and uncertainty of a full trial, while preserving the originator’s right to enforce if terms are breached.

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Frequently asked questions

Boehringer-Ingelheim v Sun — key questions answered

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Track the empagliflozin patent landscape and ANDA risk in real time

This 11-patent consent judgment confirms Boehringer’s empagliflozin franchise is protected through multiple patent expiries. Use PatSnap Eureka to monitor continuation filings, track competing ANDA challenges, and run FTO screening for your SGLT2 inhibitor pipeline.

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