Is there a generic for Levonorgestrel?

Yes. The FDA Orange Book lists 21 approved generic (ANDA) applications for Levonorgestrel, referencing the brand KYLEENA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Levonorgestrel?

KYLEENA (NDA 208224, BAYER HLTHCARE) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Levonorgestrel?

The Orange Book lists 7 patents against Levonorgestrel products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Levonorgestrel have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Levonorgestrel. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Levonorgestrel are approved?

Levonorgestrel is approved in the following dosage forms: implant, system, tablet.

FDA Orange Book · active-ingredient family

Levonorgestrel

Levonorgestrel: 10 brands, 21 generics; first approved Dec 10, 1990; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 21 ANDA applications approved.

Earliest patent expiry Feb 07, 2027Latest exclusivity ends Jun 29, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 07, 2027

in 4 mo

Brand (NDA) products

Originator applications

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KYLEENARLDRS
BAYER HLTHCARENDA 2082242016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
19.5MG SYSTEM INTRAUTERINE Rx -
LILETTARLDRS
MEDICINES360NDA 2062292015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
52MG SYSTEM INTRAUTERINE Rx -
SKYLARLDRS
BAYER HLTHCARENDA 2031592013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
13.5MG SYSTEM INTRAUTERINE Rx -
PLAN B ONE-STEPRLDRS
FDN CONSUMERNDA 0219982009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
MIRENARLDRS
BAYER HLTHCARENDA 0212252000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
52MG SYSTEM INTRAUTERINE Rx -
PLAN BRLD
FDN CONSUMERNDA 02104519992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75MG TABLET ORAL Discontinued -
0.75MG TABLET ORAL Discontinued -
JADELLERLD
POPULATION COUNCILNDA 0205441996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG/IMPLANT IMPLANT IMPLANTATION Discontinued -
LEVONORGESTREL
WYETH PHARMS INCNDA 0206271996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
75MG/IMPLANT IMPLANT IMPLANTATION Discontinued -
NORPLANT
POPULATION COUNCILNDA 0198971990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
36MG/IMPLANT IMPLANT IMPLANTATION Discontinued -
NORPLANT SYSTEM IN PLASTIC CONTAINER
WYETH PHARMS INCNDA 0200881990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
36MG/IMPLANT IMPLANT IMPLANTATION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
19.5MG	SYSTEM	INTRAUTERINE	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
52MG	SYSTEM	INTRAUTERINE	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
13.5MG	SYSTEM	INTRAUTERINE	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
52MG	SYSTEM	INTRAUTERINE	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75MG	TABLET	ORAL	Discontinued	-
0.75MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG/IMPLANT	IMPLANT	IMPLANTATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
75MG/IMPLANT	IMPLANT	IMPLANTATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
36MG/IMPLANT	IMPLANT	IMPLANTATION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
36MG/IMPLANT	IMPLANT	IMPLANTATION	Discontinued	-

Generic (ANDA) products (21)

Abbreviated applications

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LEVONORGESTREL
ANNORA PHARMAANDA 2191022025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
NAARI PTEANDA 2076602019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
XIROMEDANDA 2053292018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
LABORATOIRE HRAANDA 2040442018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
LOTUS PHARM CO LTDANDA 2026842016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75MG TABLET ORAL Discontinued -
LEVONORGESTREL
XIROMEDANDA 2027402016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75MG TABLET ORAL Discontinued -
LEVONORGESTREL
GLENMARK PHARMS LTDANDA 2070442016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
HER STYLE
NOVAST LABSANDA 2079762016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
ATHENTIA NEXT
AUROBINDO PHARMAANDA 2068672015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
ALVOGENANDA 2022462015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL Discontinued -
LEVONORGESTREL
NAARI PTEANDA 2023802015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
XIROMEDANDA 2027392014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
OPCICON ONE-STEP
SUN PHARMANDA 2026352014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
PERRIGO R AND DANDA 2023342014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
FALLBACK SOLO
LUPINANDA 2014462014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
NOVEL LABS INCANDA 2025082013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL OTC -
LEVONORGESTREL
LUPIN LTDANDA 0913282013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75MG TABLET ORAL Discontinued -
LEVONORGESTREL
FDN CONSUMERANDA 2006702012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5MG TABLET ORAL Discontinued -
LEVONORGESTREL
L PERRIGO COANDA 0907402010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75MG TABLET ORAL Discontinued -
LEVONORGESTREL
FDN CONSUMERANDA 0786652009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75MG TABLET ORAL Discontinued -
LEVONORGESTREL
WATSON LABSANDA 0786662009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.75MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.75MG	TABLET	ORAL	Discontinued	-

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

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I-917New indication exclusivity (3 years)
Jun 29, 2026
4 mo ago

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11628088	Feb 07, 2027	in 4 mo	Product
11850182	Sep 14, 2029	in 2 yr 11 mo	ProductU-3819
10561524	Sep 16, 2029	in 2 yr 11 mo	U-2948
12004992	Oct 06, 2033	in 7 yr 1 mo	Substance
11090186	Oct 24, 2033	in 7 yr 1 mo	U-2348
10028858	Mar 22, 2034	in 7 yr 6 mo	ProductU-2348
11571328	Sep 07, 2040	in 14 yr 1 mo	Product

Approval history

FDA approval span

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First approval

Dec 10, 1990

36 yr 5 mo ago

Most recent approval

Sep 30, 2025

1 yr 1 mo ago

Approvals span 1990–2025 across 31 FDA applications.

Brand (NDA) 1032%

Generic (ANDA) 2168%

Levonorgestrel: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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Key facts