$7.5M Makena Class Action Settlement - File a Claim by November 10, 2025
By Steve Levine
Published: Oct 21, 2025
Status: Open to Claims
Claim Deadline: November 10, 2025
Proof Required: No
What Is This Settlement About?
You may be part of a new $7,500,000 class action settlement reached with AMAG Pharmaceuticals, Inc. over allegations that AMAG misrepresented Makena’s effectiveness at reducing the risk of preterm birth. The FDA approved Makena in 2011 and withdrew approval in April 2023 after a post-marketing study did not confirm efficacy. AMAG denies wrongdoing. The parties agreed to settle to avoid the cost and uncertainty of further litigation.Who Is Eligible?
Natural persons in the United States who took, were prescribed, purchased, paid for, or otherwise incurred out-of-pocket costs in connection with treatment with Makena from March 8, 2019 through July 11, 2025. Exclusions apply for the Court, Defendant and affiliates, counsel, and anyone who validly opts out.Covered Products
Makena (hydroxyprogesterone caproate injection) in any dose or formulation, whether single or multi-dose vials or auto-injector, including NDCs 64011-243-01, 64011-247-02, and 64011-301-03. Generic or compounded versions are not covered.How Much Can I Get?
Payments are from the $7,500,000 Settlement Fund and may be increased or decreased pro rata so that total payments equal the available funds after fees, costs, and service awards.• With Proof of Treatment and Proof of Out-of-Pocket Payment: $22 per treatment during the Class Period. If you participated in a Government Healthcare Program at the time of treatment, $4 per treatment. Subject to pro rata adjustment.
• Without proof: $1 per treatment, up to $40 maximum. Subject to pro rata adjustment.
Who Is AMAG Pharmaceuticals?
AMAG Pharmaceuticals is a Massachusetts-based drug company that developed and sold Makena, a hormone injection meant to help prevent preterm birth. The company marketed Makena from 2011 until the FDA withdrew its approval in 2023 after studies failed to prove it worked. AMAG was later acquired by Covis Pharma, which continued selling the drug until it was pulled from the market.What Is Makena?
Makena was a prescription hormone injection made to help lower the risk of preterm birth in pregnant women with a history of early delivery. It was approved by the FDA in 2011 but later found to be ineffective. The FDA officially withdrew its approval in 2023 after studies showed no clear benefit.Do I Need Proof to File a Claim?
You can file without proofs. Providing Proof of Treatment and Proof of Out-of-Pocket Payment may result in a higher payment. Proofs can include medical or pharmacy records and receipts that show Makena treatments and what you personally paid.How Do I File a Claim?
Submit a Claim Form by November 10, 2025. File online or download and mail the form to the administrator. You can also request a form by phone or email.Key Dates
Claim submission deadline: November 10, 2025
Opt out deadline: November 10, 2025
Objection deadline: November 10, 2025
Final Approval Hearing: January 12, 2026 at 10:30 AM, Courtroom 5D, Martin Luther King Building and U.S. Courthouse, 50 Walnut Street, Newark, NJ 07101
Can I Claim If Insurance Paid?
Yes, if you had out of pocket costs like copays or coinsurance. You can claim only your own unreimbursed amount.Does This Include Generic Versions of Makena?
No. The settlement covers brand Makena only. Compounded or generic hydroxyprogesterone caproate is not included.When Will Payments Be Made?
Payments will be issued after the Court grants final approval and any appeals are resolved. Payments will be made by the method you select on the Claim Form.What Are My Options?
• Submit a Claim Form by November 10, 2025 to receive payment if eligible.• Exclude yourself by November 10, 2025 to keep your right to sue separately. You will not receive payment from this settlement.
• Object by November 10, 2025 if you stay in the class and want to tell the Court you do not like something about the settlement. You may still file a claim.
• Do nothing and remain in the class, but receive no payment and release claims resolved by this settlement.
Case Overview
Case Title: Maher v. AMAG Pharmaceuticals, Inc.Case No.: 2:20-cv-00152-JXN-JBC
Court: U.S. District Court for the District of New Jersey
Settlement Amount: $7,500,000
How To Opt Out
Submit an exclusion request online at MakenaSettlement.com by November 10, 2025, or mail a letter or Exclusion Request Form postmarked by November 10, 2025 to: Makena Claim Administrator, Attn: Exclusion Requests, PO Box 58220, Philadelphia, PA 19102. Include your full name, current address, personal signature, and a clear request to be excluded from the settlement in Maher v. AMAG Pharmaceuticals, Inc.How To Object
If you do not exclude yourself, you may object by filing a written objection received by the Clerk of the Court by November 10, 2025. Title it “Objection to Class Settlement in Maher v. AMAG Pharmaceuticals Inc., 2:20-cv-00152-JXN-JBC,” include your contact information, proof you are a Settlement Class Member, the reasons for your objection with any supporting law and facts, and your signature. Mail or deliver to: Clerk of Court, U.S. District Court for the District of New Jersey, Martin Luther King Building and U.S. Courthouse, 50 Walnut Street, Newark, NJ 07101. You may ask to speak at the hearing in your written objection.Attend the Final Approval Hearing
The hearing is set for January 12, 2026 at 10:30 AM in Courtroom 5D, 50 Walnut Street, Newark, NJ 07101, or as updated by the Court. Attendance is optional.Official Settlement Notice
Claim Form Website: MakenaSettlement.com
Submit Claim
Sources
• Official Settlement Website: www.MakenaSettlement.com• U.S. District Court for the District of New Jersey, Maher v. AMAG Pharmaceuticals, Inc., Case No. 2:20-cv-00152-JXN-JBC
Filing Class Action Settlement Claims
Please submit only truthful information. False claims can be rejected and may carry penalties. If you are unsure whether you qualify, review the official notice or contact the administrator. OpenClassActions.com is a consumer news site and is not a settlement administrator or a law firm.For more class actions keep scrolling below.
RoundUp Cancer Lawsuits: How to Qualify
Status: Open to Claims
Submit Claim
Backpage $215M Sex Trafficking Settlement
Status: Open to Claims
Submit Claim
Pickleball Class Action Settlement
Payout: $150 - $300
Submit Claim
$1.9M PetSafe e-Collar Settlement
Deadline: Dec 2, 2025
Payout: $30 - $420
Movie Theater Settlement
Deadline: December 22, 2025
Submit Claim
$6.94M Vending Machine Charges Settlement
Deadline: November 14, 2025
Submit Claim| Class Action Summary | |
| Status | Open to Claims |
|---|---|
| Claim Form Deadline | November 10, 2025 |
| Settlement Amount | $7,500,000 |
| Category | Prescription Drug Marketing |
| Estimated Payout per Person |
Proof of Treatment and Proof of Out-of-Pocket Payment: full out-of-pocket per treatment, pro
rata if needed. Proof of Treatment only: $22 per treatment, or $4 per treatment with Government Healthcare Program participation, pro rata. No proofs: $1 per treatment up to $40, pro rata. |
| Class Period | March 8, 2019 through July 11, 2025 |
| Case Number | 2:20-cv-00152-JXN-JBC |
| Case Title | Maher v. AMAG Pharmaceuticals, Inc. |
| Court | U.S. District Court for the District of New Jersey |
| Final Approval Hearing | January 12, 2026 at 10:30 AM, Newark, NJ |
| Claim Website | MakenaSettlement.com |
| Administrator Contact | Makena Claim Administrator, 1650 Arch Street, Suite 2210, Philadelphia, PA 19103 • info@MakenaSettlement.com • 1 (833) 722-4162 |