H.R. 1503House116th Congress (2019-2021)Enacted

Orange Book Transparency Act of 2020

AI-Generated Summary

Updated April 14, 2026 at 2:49 AM UTC

The Orange Book Transparency Act of 2020 changes how the FDA’s Orange Book lists patents and exclusivities for brand‑name drugs. It requires drug sponsors to submit detailed patent information when they apply for approval and to keep that information up‑to‑date. The law also adds reporting requirements and a GAO study to improve transparency for patents that cover drug‑device combinations.

Key Provisions

Applicants must provide the patent number and expiration date for any drug‑substance, formulation, or method‑of‑use patent that could be asserted when filing a new drug application.
Within 30 days of FDA approval, the approved holder must file the same patent information, and must update it if a new patent issues after approval.
The Orange Book will now list applicable exclusivity periods alongside patents, showing their expiration dates.
If a listed patent is cancelled or invalidated, the holder must notify the FDA within 14 days so the entry can be corrected, except during a 180‑day exclusivity period.
The HHS Secretary must solicit public comment on what patent data should be listed and report the feedback to Congress within one year.
The Government Accountability Office must deliver a report within two years on patents covering drug‑device combinations and recommend changes to reduce market entry barriers.

Legislative Activity

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29 earlier actions

Became Law Latest Action

Became Public Law No: 116-290.

January 5, 2021

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HouseIntro Referral

Introduced in House

March 5, 2019

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

March 5, 2019

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

March 6, 2019

HouseCommittee

Subcommittee Consideration and Mark-up Session Held.

Health Subcommittee

March 27, 2019

HouseCommittee

Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

Health Subcommittee

March 27, 2019

HouseCommittee

Committee Consideration and Mark-up Session Held.

Energy and Commerce Committee

April 3, 2019

HouseCommittee

Ordered to be Reported (Amended) by Voice Vote.

Energy and Commerce Committee

April 3, 2019

HouseCommittee

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-47.

Energy and Commerce Committee

May 2, 2019

HouseCalendars

Placed on the Union Calendar, Calendar No. 25.

May 2, 2019

HouseFloor

Ms. Eshoo moved to suspend the rules and pass the bill, as amended.

May 8, 2019 • 12:25 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H3486-3488)

May 8, 2019 • 12:25 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 1503.

May 8, 2019 • 12:25 PM

HouseFloor

At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.

May 8, 2019 • 12:36 PM

HouseFloor

Considered as unfinished business. (consideration: CR H3491)

May 8, 2019 • 1:31 PM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 422 - 0 (Roll no. 187).(text: CR H3486-3487)

View vote Passed

May 8, 2019 • 1:59 PM

HouseFloor

On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 422 - 0 (Roll no. 187). (text: CR H3486-3487)

View vote Passed

May 8, 2019 • 1:59 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

May 8, 2019 • 1:59 PM

SenateIntro Referral

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

May 9, 2019

SenateFloor

Measure laid before Senate by unanimous consent. (consideration: CR S7244)

December 7, 2020

SenateCommittee

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

Health, Education, Labor, and Pensions Committee

December 7, 2020

SenateFloor

Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7242-7243)

December 7, 2020

SenateFloor

Message on Senate action sent to the House.

December 8, 2020

HouseResolving Differences

Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.

December 10, 2020 • 12:12 PM

HouseFloor

Mrs. Dingell asked unanimous consent to take the bill, H.R. 1503 from the Speaker's Table and agree to the Senate amendment. (consideration: CR H7130-7131)

December 10, 2020 • 12:12 PM

HouseNot Used

Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7130-7131)

December 10, 2020

HouseResolving Differences

On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7130-7131)

December 10, 2020 • 12:12 PM

HouseResolving Differences

Motion to reconsider laid on the table Agreed to without objection.

December 10, 2020 • 12:12 PM

President

Presented to President.

December 24, 2020

Became Law

Signed by President.

January 5, 2021

Became Law

Became Public Law No: 116-290.

January 5, 2021

Voting History

1 vote recorded • Roll call available

HOUSE

Roll Call Available

May 8, 2019 at 1:58 PM

On Motion to Suspend the Rules and Pass, as Amended

Majority required: 2/3 (66.7%)

Passed

422 - 0

Floor Debate

6 members

What members said about H.R. 1503 on the floor

2 Republicans4 Democrats

Rep. Anna G. EshooD-CA-18 · May 8, 2019

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1503) to amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and…

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1503) to amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on H.R. 1503.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in support of H.R. 1503. This is a different color book. It is the Orange Book Transparency Act of 2019, sponsored by the gentlewoman from Illinois, Congresswoman Robin Kelly. Her bipartisan legislation makes important updates to the Food and Drug Administration's Orange Book to ensure that this resource is accurate and up-to-date to promote the development of generic drugs that save so many Americans so much money.

When it passed in 1984, the Drug Price Competition and Patent Term Restoration Act, also referred to as Hatch-Waxman, created the Orange Book as a resource for drug manufacturers to reference when deciding when and how to seek approval for new drug products. The so-called ``Orange Book'' contains valuable information, is regularly referenced by manufacturers, and is published in a user-friendly way on FDA's website.

But this resource has not been updated since it was created in 1994. That is a long time ago. It is over 3 decades ago. And the Orange Book Transparency Act of 2019 makes important updates to the resource to adapt to the changes in drug development since Hatch-Waxman became law.

Generic drug manufacturers rely heavily on the Orange Book, and it is imperative that this resource is accurate and up-to-date so drug manufacturers can invest in products that promote competition and lower drug prices for the American people.

The Orange Book Transparency Act of 2019 passed the Energy and Commerce Committee by voice vote last month, and I was proud to support it. I urge my colleagues to support the Orange Book Transparency Act of 2019 today.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 4 minutes to the gentlewoman from Illinois (Ms. Kelly), the author of H.R. 1503 and a wonderful member of the Health Subcommittee.

Mr. Speaker, I urge all Members of the House to support this bipartisan legislation that is going to move us closer to our overall goal of lowering the cost of prescription drugs for the American people.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.

Rep. Michael C. BurgessR-TX-26 · May 8, 2019

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in support of H.R. 1503, the Orange Book Transparency Act of 2019. This is a bipartisan product that moved through…

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in support of H.R. 1503, the Orange Book Transparency Act of 2019. This is a bipartisan product that moved through the Energy and Commerce Committee, and I would like to thank Representative Robin Kelly for introducing this legislation.

The publication of the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, lists drug products that have been approved by the Food and Drug Administration on the basis of safety and effectiveness. Importantly, the Orange Book lists therapeutic equivalence evaluations for approved multisource prescription drug products in addition to relevant patent and exclusivity information.

This publication provides information to State health agencies, prescribers, and to others to inform decisionmaking, and allow for the containment of healthcare costs, as well as educate the public.

A preliminary version of the Orange Book was produced in 1979. It was not until 1984, with the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch- Waxman Act, that Congress codified the Orange Book.

This bill amends existing statute to make the Orange Book more useful, particularly for manufacturers of generic drugs. Enactment of this bill will allow these manufacturers to know which branded products face competition and when those products will no longer be protected by patents. Insurance companies, doctors, and patients will be able to determine when a generic alternative is available for a more expensive branded product.

The Food and Drug Administration is already performing the practices contained in this bill, but the legislation would codify current practices and ensure that certain patents are listed in the Orange Book. Additionally, patents that are found invalid would have to be removed following the conclusion of any appeals process.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield 3 minutes to the gentleman from Kentucky (Mr. Guthrie), the Republican ranking member of the Oversight and Investigations Subcommittee of the Energy and Commerce Committee.

Mr. Speaker, I yield myself the balance of my time.

H.R. 1503 would support the work that the Food and Drug Administration is already conducting and facilitate competition in the marketplace. Therefore, I urge my fellow Members to support this important legislation.

Mr. Speaker, I yield back the balance of my time.

Rep. Robin L. KellyD-IL-2 · May 8, 2019

Mr. Speaker, I am pleased today to speak on my bill, H.R. 1503, the Orange Book Transparency Act, and the critical issue of transparency in the drug and medical device development space. Should my…

Mr. Speaker, I am pleased today to speak on my bill, H.R. 1503, the Orange Book Transparency Act, and the critical issue of transparency in the drug and medical device development space.

Should my colleagues vote in favor of this significant bill, the Orange Book Transparency Act will more efficiently achieve lowered costs and higher quality life-saving medicines for consumers. It will enhance market competition by getting generic drugs to market more rapidly. As much data show us, enhancing the market for generic drugs is one of the quickest ways to lower the costs that consumers pay at the pharmacy.

Two things matter to me with respect to healthcare costs. One, we must be proactive in enhancing transparency with regard to the information made available to generic drug developers. Most importantly, we must improve efficiency in the market for prescription drugs in order to ultimately lower costs to patients, their families, and their caregivers.

The Orange Book Transparency Act addresses both of these points by ensuring clarity in patent and exclusivity information maintained by FDA. It also requires that the Government Accountability Office study the effects of listing drug delivery patents in the Orange Book.

To be very clear, I support intellectual property protections for those researching and developing innovative treatments, but we have the responsibility to close loopholes that allow drugmakers to prevent timely access to information that would lead to new generic drug development, increasing patient access and affordability.

Today, I present a strong and straightforward piece of legislation in order to get lower-cost drugs to Americans in my district and across the country. I am ecstatic that this bill is not only straightforward but also bipartisan.

Mr. Speaker, I thank my colleague from Kentucky, Mr. Guthrie, for his work on this bill and key stakeholders for their feedback throughout the process.

The Orange Book Transparency Act moves us in the right direction toward transparency and lower drug costs.

Mr. Speaker, I urge all my colleagues to vote in support of H.R. 1503 today.

Rep. Brett GuthrieR-KY-2 · May 8, 2019

Mr. Speaker, I rise today in support of H.R. 1503, the Orange Book Transparency Act of 2019. The Food and Drug Administration's list of approved brand name therapeutic drug products, known as the…

Rep. André CarsonD-IN-7 · Jun 11, 2019

Mr. Speaker, everyone knows that Americans pay too much for their prescription drugs, and something must be done. That is why I am pleased House Democrats are addressing the rising costs of these…

Show 1 more

Rep. Jason CrowD-CO-6 · May 9, 2019

Madam Speaker, on May 8, 2019, I was unable to be present to cast my vote on the Orange Book Transparency Act (H.R. 1503) and the Purple Book Transparency Act (H.R. 1520). Had I been present for roll…

Bill Text

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Enrolled BillPublication date not provided

One Hundred Sixteenth Congress of the United States of America

At the Second Session

Begun and held at the City of Washington on Friday, the third day of January, two thousand and twenty

H. R. 1503

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes.

Short title

This Act may be cited as the Orange Book Transparency Act of 2020.

Orange Book modernization

(a)

Submission of patent information for brand name drugs

(1)

In general

Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended to read as follows:

(b)

(1)

(A)

Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—

(i)

full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;

(ii)

a full list of the articles used as components of such drug;

(iii)

a full statement of the composition of such drug;

(iv)

a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;

(v)

such samples of such drug and of the articles used as components thereof as the Secretary may require;

(vi)

specimens of the labeling proposed to be used for such drug;

(vii)

any assessments required under section 505B; and

(viii)

the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—

(I)

claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or

(II)

claims a method of using such drug for which approval is sought or has been granted in the application.

(B)

If an application is filed under this subsection for a drug, and a patent of the type described in subparagraph (A)(viii) is issued after the filing date but before approval of the application, the applicant shall amend the application to include the patent number and expiration date.

(b)

Subsequent submission of patent information

(1)

In general

Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(2)) is amended—

(A)

by inserting before the first sentence the following: Not later than 30 days after the date of approval of an application submitted under subsection (b), the holder of the approved application shall file with the Secretary the patent number and the expiration date of any patent described in subsection (b)(1)(A)(viii), except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application. If a patent described in subsection (b)(1)(A)(viii) is issued after the date of approval of an application submitted under subsection (b), the holder of the approved application shall, not later than 30 days after the date of issuance of the patent, file the patent number and the expiration date of the patent, except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application.;

(B)

in the first sentence following the sentences added by subparagraph (A), by striking which claims the drug for which and all that follows through of the drug. and inserting described in subsection (b)(1)(A)(viii).;

(C)

in the second sentence following the sentences added by subparagraph (A), by inserting after could not file patent information under subsection (b) because no patent the following: of the type for which information is required to be submitted in subsection (b)(1)(A)(viii); and

(D)

by adding at the end the following: Patent information that is not the type of patent information required by subsection (b)(1)(A)(viii) shall not be submitted under this paragraph..

(2)

Updating list

Clause (iii) of section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by striking (b) or.

(c)

Listing of exclusivities

Subparagraph (A) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following:

(iv)

For each drug included on the list, the Secretary shall specify any exclusivity period that is applicable, for which the Secretary has determined the expiration date, and for which such period has not yet expired, under—

(I)

clause (ii), (iii), or (iv) of subsection (c)(3)(E);

(II)

clause (iv) or (v) of paragraph (5)(B);

(III)

clause (ii), (iii), or (iv) of paragraph (5)(F);

(IV)

section 505A;

(V)

section 505E;

(VI)

section 527(a); or

(VII)

subsection (u).

(d)

Orange book updates with respect to invalidated patents

(1)

Amendment

Section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the following:

(D)

In the case of a listed drug for which the list under subparagraph (A)(i) includes a patent for such drug, and any claim of the patent has been cancelled or invalidated pursuant to a final decision issued by the Patent Trial and Appeal Board of the United States Patent and Trademark Office or by a court, from which no appeal has been, or can be, taken, if the holder of the applicable application approved under subsection (c) determines that a patent for such drug, or any patent information for such drug, no longer meets the listing requirements under this section—

(i)

the holder of such approved application shall notify the Secretary, in writing, within 14 days of such decision of such cancellation or invalidation and request that such patent or patent information, as applicable, be amended or withdrawn in accordance with the decision issued by the Patent Trial and Appeal Board or a court;

(ii)

the holder of such approved application shall include in any notification under clause (i) information related to such patent cancellation or invalidation decision and submit such information, including a copy of such decision, to the Secretary; and

(iii)

the Secretary shall, in response to a notification under clause (i), amend or remove patent or patent information in accordance with the relevant decision from the Patent Trial and Appeals Board or court, as applicable, except that the Secretary shall not remove from the list any patent or patent information before the expiration of any 180-day exclusivity period under paragraph (5)(B)(iv) that relies on a certification described in paragraph (2)(A)(vii)(IV).

(2)

Applicability

Subparagraph (D) of section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), as added by paragraph (1), applies only with respect to a decision described in such subparagraph that is issued on or after the date of enactment of this Act.

(e)

Review and report

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall—

(1)

solicit public comment regarding the types of patent information that should be included on, or removed from, the list under section 507(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)); and

(2)

transmit to Congress a summary of such comments and actions the Food and Drug Administration is considering taking, if any, in response to public comment pursuant to paragraph (1) about the types of patent information that should be included or removed from such list.

(f)

GAO report to congress

(1)

In general

Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States (referred to in this section as the Comptroller General) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the patents included in the list published under section 505(j)(7) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(7)) that claim an active ingredient or formulation of a drug in combination with a device that is used for delivery of such drug, including an analysis of such patents and their claims.

(2)

Content

The Comptroller General shall include in the report under paragraph (1)—

(A)

data on—

(i)

the number of patents included in the list published under section 505(j)(7) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)(7)) that claim the active ingredient or formulation of a drug in combination with a device that is used for delivery of the drug, and that together claim the finished dosage form of the drug; and

(ii)

the number of claims with respect to each patent included in the list published under such section 505(j)(7) that claim a device that is used for the delivery of the drug, but do not claim such device in combination with an active ingredient or formulation of a drug;

(B)

an analysis of the listing of patents described in subparagraph (A)(ii), including the timing of listing such patents in relation to patents described in subparagraph (A)(i), and the effect listing the patents described in subparagraph (A)(ii) has on market entry of one or more drugs approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act as compared to the effect of not listing the patents described in subparagraph (A)(ii); and

(C)

recommendations about which kinds of patents relating to devices described in subparagraph (A)(i) should be submitted to the Secretary of Health and Human Services for inclusion on the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act and which patents should not be required to be so submitted in order to reduce barriers to approval and market entry.

(g)

Conforming amendments

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—

(1)

in subsection (c)(3)(E), by striking clause (A) of subsection (b)(1) each place it appears and inserting subsection (b)(1)(A)(i); and

(2)

in subsection (j)(2)(A)(vi), by striking clauses (B) through (F) of subsection (b)(1) and inserting clauses (ii) through (vi) of subsection (b)(1)(A).

Speaker of the House of Representatives.

Vice President of the United States and President of the Senate.